JK Medirise-Disposable Medical Device Company

Breakthrough Device Designation Granted for New Neuromodulation Platform

In a pilot study treating refractory epilepsy with Neuroelectrics’ Starstim platform, patients experienced a 44 percent median reduction in seizure frequency.

Business Wire 09.22.21

Hyperfine Names Paykel, Teisseyre to Executive Leadership Roles

Neela Paykel is serving as general counsel and Tom Teisseyre assumes the chief product officer position.

Business Wire 09.22.21

Tubing & Extrusion

Accu-Tube Appoints Matthew Haddle as CEO

Haddle has a track record of leading organizations through strategic expansions across the medical device, aerospace, and industrial sectors.

Accu-Tube 09.22.21

First CellFX Procedure Performed in Canada

Pulse Biosciences expands its controlled launch of the CellFX System into the country.

Business Wire 09.22.21

Turner Imaging Systems Announces International Expansion

Company forges marketing agreement in the U.K. and Ireland.

Business Wire 09.22.21

Heraeus Acquires Mo-Sci Corporation, ETS Technology Holdings

The two deals will strengthen Heraeus' healthcare and medtech portfolio.

Heraeus 09.22.21

MedTech Innovator Names the Finalists for the Title of MedTech Innovator 2021

Attendees of The MedTech Conference, powered by AdvaMed, will vote for the Grand Prize winner.

MedTech Innovator 09.21.21

Boston Scientific Agrees to Acquire Devoro Medical

Advances its efforts to ensure physicians have the right tools to improve procedural efficiencies.

Boston Scientific 09.21.21

CE Mark Granted to Predictive Software for Kidney Allograft Survival

Algorithm gives the probability the graft will still be functional at three, five, and seven years after evaluation by a healthcare professional.

Cibiltech 09.21.21

Electroducer Raises 3 Million Euros to Market Heart Valve Disease Tech

Electroducer Sleeve based on a medical technique called Direct Wire Pacing, which was invented by the company’s founder.

Electroducer 09.21.21

OmniVision Debuts Industry’s First 8 Megapixel Medical-Grade Image Sensors

The OH08A/B image sensors provide high resolution with excellent image quality for 10-12mm outer diameter endoscopes.

OmniVision Technologies Inc. 09.21.21

Diagnostics

FDA Warns of Possible False Positives for Abbott COVID-19 Lab Tests

May be related to current mixing parameters of the PCR reaction mixture.

U.S. Food and Drug Administration 09.20.21

Surgical

Precision Coating Merges with N2 Biomedical

Expands its medical coatings platform.

Ampersand Capital Partners 09.20.21

Diagnostics

Babson Diagnostics Raises $31 Million in Series B Funding

Money will be used to help drive commercialization of customer-first, highly accessible diagnostic blood testing.

Business Wire 09.20.21

Patient Monitoring

VitalConnect Launches New Version of VistaCenter for Cardiac & Remote Patient Monitoring

Brings market-leading patient management and monitoring tools to physicians.

VitalConnect Inc. 09.16.21

Medical Devices Market to Top $671.49 Billion by 2027

Wearables and rising cases of chronic diseases will help fuel growth, industry data predicts.

Precedence Research 09.16.21

Improved Outcomes Proven With Insulet’s Omnipod 5 System

Studies show the automated insulin delivery system improved HbA1c nearly one percentage point in kids and 0.60 percent in adolescents and adults.

Business Wire 09.16.21

Diagnostics

Siemens Healthineers’ Somatom X.ceed Tomography Scanner Cleared by FDA

Expands precision medicine and transforms care delivery.

Siemens Healthineers 09.14.21

Surgical

Molli Surgical's Breast Tumor Marker

MPO's Sean Fenske speaks with Dr. Fazila Seker of MOLLI Surgical about the benefits of her company’s breast tumor marking system.

Sean Fenske, Editor-in-Chief 09.14.21

Digital Health

The Benefits of Computer Vision Technology for Healthcare Applications

How new technology could save millions of dollars and help patients receive better treatment.

Henry Bell, Head of Product at Vendorland 09.13.21

Patient Monitoring

Masimo Launches Single-Patient-Use rainbow SuperSensor in Europe

Uses 12 LEDs to simultaneously offer 12 blood constituent parameters noninvasively and continuously.

Business Wire 09.13.21

Vertigo Treatment Receives FDA Breakthrough Device Designation

The device's developer—Otolith Labs—closes $3.3 million in seed financing.

Business Wire 09.13.21

Digital Health

RapidAI Launches Rapid Workflow for Pulmonary Embolism

Rapid Workflow for PE helps hospital teams align, activate and communicate about patient status to administer care faster.

RapidAI 09.13.21

RapidPulse Closes $15 Million Series A Financing

Two industry veterans join the team to support the development of a cyclic aspiration system for ischemic stroke.

Globe Newswire 09.10.21

Quanta Raises $245 Million in Series D Funding Round

Money will help accelerate the commercialization of the company's SC+ Portable Hemodialysis System.

Business Wire 09.10.21

Thermo Fisher Scientific Launches Updated COVID-19 Test

Updated version of highly sensitive and accurate COVID-19 PCR kit accounts for known and future viral mutations.

PR Newswire 09.10.21

Contract Manufacturing | R&D & Design

Midwest Products & Engineering Acquires MindFlow Design

Design firm to enhance MPE's concept to completion model.

PR Newswire 09.10.21

Know Labs Awarded New Patent for Non-Invasive Diagnostic Tech Platform

Company has been granted 22 patents to date and has 35 more pending.

Business Wire 09.09.21

Vicarious Surgical Opens New Corporate Headquarters in Massachusetts

The new space houses a full-scale operating room for robotics testing as well as R&D and company operations.

Business Wire 09.09.21

Neurological | Patient Monitoring

FDA OKs NeuroOne's Evo sEEG Electrode

Company's second FDA 510(k) clearance received.

PR Newswire 09.08.21

Luis J. Malavé Joins Integrity Applications Board

New member has more than 30 years of leadership experience in the medtech industry, primarily in diabetes management.

Globe Newswire 09.08.21

Surgical

Stryker Buys Gauss Surgical

Gains Triton AI-enabled platform for real-time monitoring of blood loss during surgery.

PR Newswire 09.07.21

Cardiovascular

FDA Approves TransMedics' OCS Heart System for Donor Hearts

Indicated for preservation of DBD (donors after brain death) hearts.

PR Newswire 09.07.21

Surgical

RonovoRx's RenovoCath Earns New FDA 510(k)

Use of RenovoCath may improve targeted delivery of chemotherapy.

PR Newswire 09.07.21

CE Mark Granted to Expandable, Biodegradable Biliary Stent

The UNITY-B Percutaneous Balloon Expandable Biodegradable Biliary Stent is intended to facilitate the drainage of obstructed ducts requiring larger openings.

PR Newswire 09.07.21

Bright Future Ahead for Renal Denervation

No devices yet approved in the United States for the high blood pressure treatment.

GlobalData 09.02.21

Global Brain Computer Interface Market to Top $1.6B by 2028

Growth partly expected from collaborations among various research institutes to develop bran disease diagnostics.

Globe Newswire 09.02.21

Cardiovascular

Abbott Buys Walk Vascular, a Thrombectomy System Maker

Adds mechanical thrombectomy devices for treating patients with peripheral blood clots.

PR Newswire 09.02.21

Baxter to Acquire Hillrom in $10.5 Billion Deal

The acquisition will broaden access to care in the hospital, home and alternate site settings.

Baxter International 09.02.21

Sectoral Asset Management Invests $9M in Cagent Vascular

Money will be used to help manufacture and commercialize the Serranator product.

Business Wire 09.01.21

Aleva Neurotherapeutics Recruits First Patient Into PMCF Study

Study aims to demonstrate improved outcomes with Aleva´s directSTIM Directional Deep Brain Stimulation system.

Globe Newswire 09.01.21

Surgical

Boston Scientific Closes Lumenis Surgical Biz Deal

Company gains laser systems, fibers, and accessories for urology and otolaryngology procedures.

PR Newswire 09.01.21

COVID-19 Accelerated Demand for Handheld Ultrasound Devices in China

Market for these products is expected to grow 5 percent through 2025.

GlobalData 09.01.21

iNitrile's Co-Founder Raises $33M for the Company

Company will use the money to further develop its automatic glove dispenser process.

Business Wire 08.31.21

Chronic Disease

Glooko’s Remote Patient Monitoring for Diabetics

MPO's Sean Fenske speaks with Russ Johannesson of Glooko about the advantages of being able to monitor diabetes remotely.

Sean Fenske, Editor-in-Chief 08.31.21

Electronics | R&D & Design

Closed Loop Thermal Control in Medical Devices

A closed-loop feedback approach is an effective mechanism to address thermal control challenges.

Kenneth MacCallum, P.Eng., Principal Engineering Physicist, StarFish Medical 08.30.21

Molding

Westfall Technik Opens New Medical Molding Plant and Clean Room

The 40,000-square-foot facility near Chicago features three Class 8-certified clean rooms and one white space for helping firms meet GMP requirements.

Business Wire 08.30.21

Ramin Mousavi Appointed CEO of CathWorks

New leader worked at Baxter International and Edwards Lifesciences.

PR Newswire 08.27.21

Diagnostics

FDA Issues EUA for BD Veritor At-Home Covid-19 Test

The test does not require a prescription, a laboratory or a long wait for results.

BD 08.26.21

PartsSource Unveils New Operations Dashboard

New dashboard gives clients real-time insights across the medical device supply chain.

Business Wire 08.26.21

Digital Health

Why Patient Data Security is of Essential Importance in 2021

How to protect confidential patient information and comply with regulations such as HIPAA.

Anton Zheliabin, Product manager, ComeBack Mobility 08.25.21

Putnam Plastics Corporation Completes Facility in CT

New addition provides additional space for the company to continue to grow and support the growing needs of its partners within industry.

Putnam Plastics Corporation 08.24.21

Able Medical Launches the Valkyrie Thoracic Fixation System

The product is a single-use, bioactive sternal plating system for use after open heart surgery.

Business Wire 08.24.21

Safeguard DNA Diagnostics Launches Dry Collection Swabs for COVID-19 Testing

The dry swabs are being rolled out in Philippine laboratories.

Business Wire 08.24.21

Patient Monitoring

Valencell’s Wearable Biomedical Sensors

MPO's Sean Fenske speaks with Dr. Steven LeBoeuf of Valencell about the advantage of biomedical sensors that can be integrated into many devices.

Sean Fenske, Editor-in-Chief 08.24.21

Stanislav Glezer Joins Inogen as Chief Medical Officer

New hire most recently worked for Becton, Dickinson and Company as worldwide vice president of Medical Affairs for Diabetes Care.

Business Wire 08.24.21

Packaging & Sterilization

Amcor Launches Enhanced Heat Seal Coating Technology

New heat seal adhesive helps medical device manufacturers better mitigate risk for greater patient safety.

Amcor 08.23.21

DFM and Scientific Molding: Reduce Medical Tooling Costs and Validation Times

Looking to reduce lead time and costs in medical tooling?

08.19.21

Neurological

FDA OKs BrainsWay Deep TMS to Reduce Anxiety in Depressed Patients

Expanded depression indication further demonstrates company’s leadership position.

GlobeNewswire 08.19.21

Glaukos' PRESERFLO MicroShunt Approved in Australia

Product is an ab-externo, drainage system that helps drain eye fluid and reduces IOP in patients with primary open-angle glaucoma.

Business Wire 08.19.21

Digital Health

iCAD Signs Global Distribution Agreement With Sectra

Agreement will expand access to ProFound AI and ProFound AI Risk to more facilities and imaging centers worldwide.

Globe Newswire 08.19.21

Butterfly Network Building New Corporate Headquarters in Massachusetts

New facility will have the capacity for approximately 275 people with the ability to expand further.

Business Wire 08.19.21

Cala Health Expands its Executive Team

Steve Higa and Greg Schulte add deep strategic experience, operational excellence to the company's management.

Business Wire 08.19.21

Cardiovascular

Abiomed's Impella ECP Heart Pump Granted Breakthrough Status

The world’s smallest heart pump, according to the company.

Business Wire 08.19.21

Diagnostics

EchoNous’ Lexsa Linear Probe Cleared by FDA

An ultra-portable device capable of producing diagnostic-quality images rivaling those from larger, more expensive cart-based units.

EchoNous 08.19.21

Electronics

Freudenberg Medical Increases Capabilities for Sensor Integration

Positions the company to work with sensors such as temperature and pressure sensors, entire sensor arrays, and fiber optic sensors.

Freudenberg Medical 08.18.21

Diagnostics

FDA Extends EUA for Spectrum Solutions’ SDNA-1000 Saliva Collection Device

New authorization includes the unsupervised self-collection of saliva for COVID-19 testing.

Spectrum Solutions 08.18.21

Probo Medical Acquires Tenvision

Deal is the fourth acquisition for the company this year.

Business Wire 08.18.21

Machining & Laser Processing

The Importance of Metal Fabrication in the Innovation of Medical Devices

How metal fabrication powered by CNC machines has come to the rescue of the innovation of medical devices.

Peter Jacobs, senior director of marketing at CNC Masters 08.17.21

R&D & Design

Trelleborg Launches Rapid Development Center in Minnesota

Provides Trelleborg’s healthcare and medical customers a single partner for design, rapid prototyping, development and serial production.

Trelleborg 08.16.21

Materials

Developing Next Generation Implants with Bioresorbables—A Medtech Makers Q&A

To help restore natural anatomy following a medical procedure, some device makers are curious about bioresorbable molded devices.

Minnesota Rubber and Plastics Announces New Innovation Center

Will offer customers an engineer-to-engineer collaboration experience designed to improve product performance and enhance speed-to-market.

Minnesota Rubber and Plastics 08.13.21

Health Canada Approves Butterfly iQ+ Platform

The second-generation handheld device is now available in 20 countries worldwide.

Business Wire 08.13.21

Satellite Healthcare, Outset Medical Partner to Boost Home Dialysis

Outset Medical’s Tablo Hemodialysis System selected as the tech to further enable Satellite Healthcare’s efforts to drive home hemodialysis growth.

Business Wire 08.13.21

HD Medical Appoints Shaun Setty as Chief Medical Officer

Cardiothoracic surgeon positions the company for growth in the CVD detection and monitoring market.

Business Wire 08.13.21

First Clinical Use of SoundBite Medical's Active Wire Platform

Doctors tout strong results with the company's Active Wire 0.014-inch platform in severely calcified peripheral lesions.

Business Wire 08.13.21

Molding Modern Medtech

Insights on best practices and technologies for successfully specifying molded components.

08.12.21

Cardiovascular

Acutus Medical Receives FDA Clearance for AcQMap 8 Software Upgrades

Introduces advanced new mapping algorithms into the AcQMap 3D imaging and mapping system.

Acutus Medical 08.12.21

Surgical

FDA Clears 3NT Medical’s Peregrine Drivable ENT Scope

Provides ENT surgeons with unparalleled views of the sinus anatomy to enhance the surgical experience.

3NT Medical 08.12.21

Diagnostics

BD Launches FACSymphony A1 Benchtop Cell Analyzer

Brings sophisticated flow cytometry capabilities to laboratories of all sizes.

BD 08.12.21

BD Names Christopher DelOrefice as EVP and CFO

DelOrefice joins the company from Johnson & Johnson.

BD 08.12.21

Digital Health

Four Real-World Applications for Voice Tech in Healthcare

How voice enablement is impacting seniors and healthcare professionals.

Bruce Ryan, Director of Engineering, Harman Embedded Audio 08.11.21

Tubing & Extrusion

A Quality Validation Program for Extrusion—MPO Videobites

Tim Steele of Microspec Corporation offers insights on the importance of a validation program for extrusion for medical device makers.

Cardiovascular

Philip Morris International Acquires OtiTopic

PMI will use the purchase to grow its pipeline of ‘Beyond Nicotine’ inhaled therapeutic products.

Philip Morris International Inc. 08.11.21

Surgical

FDA OKs Boston Scientific's EXALT Model B Single-Use Bronchoscope

Designed for bedside procedures in the ICU and OR.

PR Newswire 08.10.21

Nolato AB Finalizes Two North American Expansions

Adds space for new programs in Vermont and Wisconsin.

Nolato AB 08.10.21

Chronic Disease

HIMSS 2021: Siemens Healthineers Adds Cell Lung Cancer Pathway for AI-Pathway Companion

Assists multidisciplinary teams by facilitating patient management and case reviews in a single dashboard.

Siemens Healthineers 08.10.21

Neurological | Software & IT

FDA OKs SpinTech's STAGE MRI Software

Allows scanning the entire brain in roughly five minutes.

PR Newswire 08.09.21

Diagnostics | Digital Health | Software & IT

GE Healthcare, AWS Partner to Transform Care Delivery

AI-based imaging applications and Edison Health Services platform on AWS.

Business Wire 08.09.21

Digital Health | Software & IT

HIMSS 2021: Philips Introduces Two New HealthSuite Solutions

Cloud-based solutions for orchestrated patient logistics and enterprise telehealth for acute care.

GlobeNewswire 08.09.21

Neurological

FDA Approves ZOLL's remedē for Central Sleep Apnea

Transvenous phrenic nerve stimulation for moderate to severe CSA approved.

Business Wire 08.06.21

How to Become ISO 13485 Certified

Complying to ensure lifelong quality of medical devices and gain access to certain medical device markets.

Emily Drinks, Digital Content Consultant with WebFX 08.05.21

Cardiovascular

Early Catheter Ablation of VT Outperforms Conventional Medical Therapy

First randomized trial of its kind to enroll patients with nonischemic cardiomyopathy.

Heart Rhythm Society 08.05.21

Draper Makes Advances in Extracorporeal Membrane Oxygenation

Develops artificial lung technology with $4.9 million army grant.

08.04.21

Cardiovascular

FDA OKs Abbott's AI OCT Imaging for Vessels in the Heart

Ultreon 1.0 Software is the first-of-its-kind imaging software according to the company.

PR Newswire 08.04.21

Digital Health

How Medical Device Connectivity Is Improving Accessibility in Healthcare

The fifth generation of wireless connectivity sets the stage for better medical devices.

Adrian Johansen 08.03.21

Digital Health

Baxter Begins Collaboration with Amazon Web Services

Advancing strategic priorities in digital health, customer experience, and technology modernization.

Baxter 08.03.21

Materials

Smaller Devices Require More Efficient Material Integration

Silicones are becoming increasingly well-suited for implantable medical devices and combination products.

Michael Barbella, Managing Editor 08.03.21

Chronic Disease

Abbott Fined $160M to Resolve Medicare Diabetes Lawsuit

Resolves allegations Abbott companies Arriva and Alere made, or caused, claims to Medicare that were false.

U.S. Department of Justice 08.02.21

Chronic Disease | Patient Monitoring | Software & IT

FDA OKs Abbott's FreeStyle Libre 2 iOS App

Users can check glucose with a compatible iPhone every minute with optional real-time glucose alarms.

Abbott Laboratories 08.02.21

Digital Health

Hello Heart Raises $45M to Expand Digital Heart Health Platform

Series C financing was led by IVP and includes existing investors.

Business Wire 08.02.21

Non-Profit Group Launches Initiative to Diversify Medtech Workforce

Collaborative Community developing ways to recruit and retain minority physicians, researchers, and other stakeholders in research and product development.

Business Wire 08.02.21

Materials

Pandemic Underscores Importance of Medtech Material Innovation

Materials must meet the changing needs of medtech and society in general through preventative, diagnostic and therapeutic solutions.

Michael Barbella, Managing Editor 07.30.21

Promaxo Taps Srirama Venkataraman as VP of Clinical Research & Strategy

With previous roles at Philips and Stryker, Dr. Venkataraman will bring his expertise to Promaxo’s MRI and robotic platform.

Business Wire 07.30.21

Cardiovascular | Digital Health

BioFourmis' Digital Heart Failure Therapeutic Earns Breakthrough Status

Augments guideline-directed use of heart failure medications.

PR Newswire 07.30.21

Diagnostics

KA Imaging Forges U.S. Distribution Deal With Alpha Imaging

Alpha Imaging serves 14 states in the Northeast, mid-Atlantic, and central U.S.

KA Imaging 07.30.21

Neurological

Nevro Corp Receives FDA Approval for Senza System

The 10 kHz high frequency spinal cord stimulation therapy is designed for treatment of chronic pain associated with painful diabetic neuropathy.

Nevro Corp. 07.29.21

Outset Medical Appoints Katie Szyman to its Board

Szyman joins four other female leaders on the company's Board of Directors.

Outset Medical Inc. 07.29.21

Confluent Medical Expanding Costa Rica Manufacturing Facility

Company is adding capacity for nitinol processing and catheter manufacturing.

Business Wire 07.29.21

3D/Additive Manufacturing | Software & IT

3D Systems Sells Simbionix to Surgical Sciences for $305M

Divestiture results from company’s singular focus on additive manufacturing.

3D Systems 07.29.21

Surgical

Baxter Buys CryoLife's PerClot Polysaccharide Hemostatic System

Marks Baxter’s entry into the attractive global hemostatic powder segment.

Baxter 07.29.21

Gerald R. Mattys Joins Pelvital USA Board of Directors

Newest member most recently served as CEO at Tactile Medical.

Business Wire 07.29.21

Molding

Rapidwerks Expands its Molding Capabilities

Company has added four injection molding machines to provide customers with larger components.

Rapidwerks Inc. 07.28.21

'Yo-Yo' Growth Seen for Global Respiratory Protective Equipment Market

High costs associated with supplied-air respirators could act as a bottleneck to the market expansion, however.

Globe Newswire 07.27.21

Global Peripheral Intravenous Catheter Market to Reach $7.3B by 2027

Driving the sector are trends such as the increasing incidence of chronic and life threatening diseases.

Business Wire 07.27.21

Packaging & Sterilization

Facility Falsified Sterilization Data—Mike on Medtech

Mike Drues and Sean Fenske discuss troubling concerns over a sterilization provider in Italy.

Sean Fenske, Editor-in-Chief 07.27.21

Materials

Disinfectant Resistance is Crucial in Medtech Material Selection

Understanding the kinds of materials that stand up to healthcare-grade disinfectants can help ensure device longevity.

Michael Barbella, Managing Editor 07.27.21

Cardiovascular

Data Confirm the Accuracy of HeartFlow Planner in Modeling Post-PCI Outcomes

The interactive planning tool enables heart teams to modify vessels virtually and determine the optimal treatment strategy before procedures.

Business Wire 07.23.21

Materials

Electronics Integration Impacting Medtech Materials

Conductive materials are becoming a necessary part of medical devices as digital healthcare continues to evolve.

Michael Barbella, Managing Editor 07.23.21

BD Acquires Velano Vascular

Will use innovative needle-free blood draw technology to reduce pain and discomfort of multiple needlesticks.

BD 07.22.21

Pratip Dastidar Joins Establishment Labs as Head of Global Operations

New hire will also lead the company’s digital transformation initiatives.

Business Wire 07.20.21

Diagnostics

Nova POC Creatinine/eGFR Method More Accurate Than Lab Method

One of the first studies to compare the accuracy of POC creatinine/eGFR devices to iohexol mGFR method yields promising results.

Nova Biomedical 07.20.21

Knobbe Martens Talks Trade Secrets

MPO's Sean Fenske speaks with Adam Powell of Knobbe Martens about a company’s trade secrets and how to protect them.

Sean Fenske, Editor-in-Chief 07.20.21

Cardiovascular

CARMAT Celebrates First Aeson Artificial Heart Commercial Implant

Represents first CARMAT sale, paves the way for the company’s commercial development.

Business Wire 07.20.21

Diagnostics

Owlstone Medical Launches Breath Testing for Digestive Health

Testing enables patients to take better control over their digestive health through a simple at-home breath test.

Owlstone Medical 07.19.21

MDIC Partners With Booz Allen on Device Cybersecurity

Companies will identify best practices in cybersecurity benchmarking that can be replicated by manufacturers to ensure patient safety and security.

Business Wire 07.19.21

Outset Medical Joins Home Healthcare Initiative

Dialysis services provider will partner with Moving Health Home to increase access to home healthcare.

Business Wire 07.19.21

Study Confirms Benefits of ZOLL's Implantable Sleep Apnea Device

Data show sustained improvement in sleep disordered breathing, arousals, sleep architecture, and daytime sleepiness through five years.

Business Wire 07.19.21

Global Enteral Feeding Devices Market to Reach $4.85 Billion by 2027

Innovation and product launches are expected to drive growth.

Business Wire 07.14.21

Digital Health

DataRobot Launches AI for Health Incubator

Company is accelerating critical healthcare research to help physicians and medical professionals better leverage AI.

Business Wire 07.14.21

VistaMed, OneProjects and Tyndall Receive €5.1 million to Improve Treatment of Cardiac Arrhythmias

Project aims to provide a catheter to deliver direct 3D, intraprocedural analysis of the success of cardiac ablation, in the treatment of atrial fibrillation.

VistaMed 07.14.21

Patient Monitoring

Survey: Patient Focus Breeds Success for Remote Cardiac Monitoring Programs

Data show practices struggle to keep patients engaged in their care, straining staff and making it impossible for clinical and financial benefits to be realized

Business Wire 07.14.21

Digital Health

Tilak Healthcare Launches U.S. Pilot for Medical Vision Monitoring App

The smartphone app is especially suited to monitor patients with chronic eye diseases associated with aging.

Business Wire 07.14.21

Second Sight Touts Cortical Prosthesis Study Results

Preliminary findings show participants benefit from Orion Visual Cortical Prosthesis.

Business Wire 07.14.21

Substantial Growth Predicted for Global Ventilators Market

Aging population, increasing infectious disease rates to drive growth through 2026.

Market Study Report 07.13.21

Tubing & Extrusion

Thousands of Stock Components for Medtech—MPO Videobites

Jeff Cushner of Qosina speaks with MPO's Sean Fenske about how his company fulfills medical device component needs rapidly.

Cardiovascular

HeartFlow Completes Patient Enrollment in the PRECISE Trial

More than 2,000 patients enrolled in randomized controlled trial to evaluate a precision-testing pathway for suspected coronary artery disease.

Business Wire 07.13.21

Cardiovascular

Endologix Launches ALTO Abdominal Stent Graft System in Canada, Argentina

Company expands global reach with latest endovascular aneurysm repair technology.

07.13.21

Fluid Management System Market to be Worth $23.2 Billion By 2028

North America dominated the global market for fluid management system in 2020 and will continue that dominance over the next seven years.

Polaris Market Research 07.13.21

Avanos Medical Fined $22M for MicroCool Surgical Gown Misbranding

Gowns were falsely labeled as providing the highest level of protection against fluid and virus penetration.

U.S. Department of Justice 07.12.21

Xenter Appoints Four Healthcare Industry Leaders to its Board

Company also closes a $12 million Series A stock offering.

Business Wire 07.12.21

Testing

EAG Expands Medical Device Testing Services With New Lab

The laboratory includes a dedicated medical device polymer analysis area.

Business Wire 07.12.21

Contraline Expands Board of Directors

Medical device industry veteran Martin J. Emerson has joined the company's board.

Business Wire 07.09.21

Digital Health

ClearDATA, BioIntelliSense Collaborate to Enhance RPM Security and Compliance

Compliant transmission of medical grade data from the home enables providers to safely monitor patients and meet demand for scalable remote care.

Business Wire 07.09.21

Cardiovascular | Patient Monitoring

FDA OKs QTc Interval Measurement for AliveCor's Personal ECG

Long QTc interval is a potentially life-threatening side effect of certain medications.

PR Newswire 07.09.21

Diagnostics

Lumos Diagnostics Appoints Three Industry Leaders as Independent Directors

Trio brings strong knowledge of equity markets and broad corporate governance expertise to the firm.

Business Wire 07.09.21

Neurological

Royal Philips Enters Strategic Partnership with NICO.LAB

Advances its commitment to improving outcomes for people who suffer a stroke.

Philips 07.08.21

First U.S. Ischemic Stroke Patients Treated With Rapid Medical’s Clot Retriever

TIGERTRIEVER is the only physician-adjustable device for greater procedural control.

Michael Barbella 07.08.21

Surgical

USMI Developing First Robotic System for Cancer Surgery

Stand-alone solution for robotic-assisted surgery will target open, laparoscopic/mini-invasive, endoscopic, thoracoscopic, and trans-oral surgical procedures.

Business Wire 07.08.21

Cardiovascular

Enrollment Underway in Philips' WE-TRUST Stroke Study

Will assess impact of the Direct to Angio Suite workflow in improving patient outcomes.

Philips 07.07.21

Confluent Medical Invests in The Electrospinning Company

The investment will enable Confluent to expand its design options used in structural heart markets.

Business Wire 07.07.21

Santen Granted Health Canada Approval of PRESERFLO MicroShunt

The product is currently available in Europe.

Business Wire 07.07.21

EU MDR Preparedness: How Is COVID-19 a Factor?

Properly plan ahead so that your company can tackle regulatory hurdles without any struggles.

Jon Speer, Founder of Greenlight Guru 07.06.21

Contract Manufacturing

Receiving FDA Approval in Under One Month

How the team working on an “Open-Source” COVID Ambu-bot Ventilator optimized its short timeline.

Aaron Burlew, Senior Applications Engineer, Teknic Inc. 07.06.21

Cardiovascular

Implicity’s Cardiac Device Remote Monitoring

MPO's Sean Fenske speaks with Dr. Arnaud Rosier of Implicity about the cardiac device monitoring solutions his company offers.

Sean Fenske, Editor-in-Chief 07.06.21

Cardiovascular | Surgical

Surmodics Buys Vetex Medical

Adds ReVene Thrombectomy Catheter to the company's portfolio.

Business Wire 07.06.21

Contract Manufacturing

MPE Inc. Expands Into EMEA Market

Company has hired a director of International Markets to help lead the expansion.

PR Newswire 07.06.21

Molding

Why is it Suddenly Difficult to Buy Plastic Components in 2021?

Analyzing the pandemic’s impact on the bioprocess and medical device industries.

Dave Splett , VP of Business Development at Injectech, LLC 07.02.21

Surgical

Robocath Completes First Robotic Coronary Angioplasties in Belgium

The first robotic procedures are part of a clinical study which involves six European centers.

Robocath 07.02.21

Surgical

FDA Clears Standard Bariatrics' Stapling Technology for Sleeve Gastrectomy

The Titan SGS design ensures more consistent staple formation across the entire 23-centimeter cutline.

PR Newswire 07.02.21

R&D & Design

Medical Device Development: Three Tips for Success

Analyzing the design phase of the medical device development process.

Shrinidh Joshi, medtech consultant on Kolabtree 07.01.21

Diagnostics

Global POC Diagnostic, Testing Market to Top $34B by 2027

The advent of advanced technologies, a growing geriatric population, and the rising prevalence of infectious as well as chronic diseases will help drive growth.

Globe Newswire 07.01.21

Safeguard Medical Buys PerSys Medical

Brings broadest portfolio of life-saving medical equipment, tech, services to first responders.

PR Newswire 07.01.21

OnLume Surgical Completes $7 Million Series A Financing

Funding supports commercial launch of novel fluorescence image-guided surgery system.

Business Wire 07.01.21

Diagnostics

How an MDQMS Can Lead to More Efficient and Sustainable Diagnostic Tests

Leveraging technology to improve speed to market without sacrificing quality.

Brandon Henning, VP of Product at Greenlight Guru 07.01.21

Surgical

The Future of AI and OR Medical Devices

Bringing artificial intelligence to the operating room.

Michael Hutton, Upper GI Specialist at Royal Cornwall Hospitals NHS Trust 06.30.21

Cardiovascular

The Reemergence of Pulsed Field Ablation in Cardiac Electrophysiology

Reviewing the innovative technology’s history and impact on persistent atrial fibrillation.

Steven Mickelsen, MD, Chief Translational Science Officer, Acutus Medical 06.29.21

Medtronic Starts Construction on New Innovation Center

Will unite over 1,000 employees from the Boulder and Louisville facilities onto one campus.

Medtronic plc 06.29.21

Diagnostics

Interventional Systems’ Miniature Medical Robot Cleared by FDA

Makes way for the European company to start building its U.S. presence.

Interventional Systems 06.29.21

Diagnostics

PixCell's Rapid Blood Test Diagnostics

MPO's Sean Fenske speaks with Hanan Ben-Asher of PixCell Medical about the opportunities enabled with rapid blood diagnostics.

Sean Fenske, Editor-in-Chief 06.29.21

Cardiovascular

FDA Approves Abiomed's Next-Gen Impella RP for Right Heart Failure

Safe and effective to treat acute right heart failure for up to 14 days.

Business Wire 06.29.21

TÜV SÜD North America Gains FDA Accreditation for Device Testing

TÜV SÜD offers ASCA-accredited laboratory testing of medical devices at five U.S. locations and in Canada.

Business Wire 06.29.21

Cardiovascular

FDA Approves AtriCure's EPi-Sense System for Persistent Afib

Trial showed a 29 percent difference in effectiveness at 12 months, a 35 percent difference in effectiveness at 18 months for long-standing persistent Afib.

Business Wire 06.29.21

Digital Health

Canon Medical Expands AI-Based Image Reconstruction Tech

AiCE) Deep Learning Reconstruction can now be used for 96 percent of all procedures using the Vantage Galan 3T MR system.

Business Wire 06.29.21

Aziyo Biologics Begins De Novo CanGaroo Clinical Study

Trial aims to provide insights into the profiles of patients selected for CanGaroo Envelope implantation.

Globe Newswire 06.29.21

Wellesley College President Joins Abiomed Board of Directors

Paula A. Johnson, M.D., also was a professor of medicine at Harvard Medical School.

Business Wire 06.28.21

Cardiovascular

Paragonix Study Shows Improved Outcomes for Heart Transplant Patients

Donor hearts preserved by the company's SherpaPak had statistically significant increases in total ischemic time and travel distance.

Business Wire 06.28.21

COVID-19 Sample Collection Kits Market to Reach $16.56B by 2028

Most lucrative growth to occur in Asia Pacific region.

Polaris Market Research 06.28.21

New miniature drives for medical robots and multi-axis systems

maxon is once again expanding its range of configurable drives with more brushless DC motors, gearheads, and encoders from the ECX series.

maxon drives are heading to the Red Planet with NASA’s Perseverance rover

In July, NASA will be sending its fifth rover to Mars.

Now available: new DRIVEN magazine and maxon’s product catalog

The new issue of DRIVEN, the maxon magazine, awaits the reader with fascinating articles about agricultural robotics, drone technology, and cleanrooms.

AdvaMed Encourages Biden to Prioritize Medical Supplies Transport

Hoping to see supply chain bottlenecks alleviated before Fall due to flu season and uncertainty around COVID variants.

AdvaMed 06.23.21

Surgical

Medtronic’s Hugo Robotic Surgery System Makes Clinical Debut

The robotic prostatectomy marked the start of the Hugo RAS System global patient registry.

PR Newswire 06.23.21

Digital Health

Pear Therapeutics to Become Public Company

Seeks to expand its leadership position in prescription digital therapeutics.

Pear Therapeutics 06.23.21

Canada Approves Drug-Releasing Contact Lens for Eye Allergies

Daily disposable lens corrects vision and provides relief to patients suffering from allergic conjunctivitis.

PR Newswire 06.23.21

Surgical

Ethicon Launches ENSEAL X1 Curved Jaw Tissue Sealer

Bipolar energy device increases procedural efficiency and provides stronger sealing.

PR Newswire 06.22.21

Diagnostics

DARPA Enlists University to Develop AI for Portable Ultrasound

Research team will put expert knowledge at the fingertips of frontline medics.

Carnegie Mellon University 06.22.21

MedTech Innovator Selects 20 Firms for Asia Pacific Accelerator

Finalist companies comprised of promising entrepreneurs from the Asia Pacific Region.

Business Wire 06.22.21

Elixir Medical Expands DynamX Study to Facilities in Two European Countries

Trial is enrolling 444 patients from 30 centers in Europe and Japan.

Business Wire 06.21.21

Second U.S. Patent Awarded to Alvalux for Wearable Light Therapy Device

Company received its first patent earlier this year for a wearable dermal repair system marketed under the CicaLux brand.

PR Newswire 06.21.21

Digital Health

LifeConnect Partners With Movement Interactive and AffirmXH

The partnership will now expand the Hiji Band’s potential into healthcare, providing new data sources from patients in their real environments.

LifeConnect 06.18.21

Surgical

RSIP Vision Offers Real-Time Surgical Workflow Recognition for Robotic Surgery

The module automatically tracks and identifies surgical steps during procedures, providing the basis for intraoperative clinical decision support systems.

RSIP Vision 06.17.21

Spectrum Plastics Group Buys KCS Plastics Ltd.

Acquisition brings blown films capacity and new capabilities to the firm.

Spectrum Plastics Group 06.15.21

Kerecis Introduces Fish Skin Product for Healing Burns

Large, mesh fish-skin grafts from Iceland can bring relief to patients and help them regain active lives.

Business Wire 06.15.21

Global Ophthalmic Viscoelastic Devices Market to Reach $1.4B by 2030

'Ssurge period’ in procedures and OVD sales to begin, but the increase will not offset pandemic-induced revenue losses until next year.

GlobalData 06.15.21

Philips Recalls Certain Sleep and Respiratory Care Devices

Mitigates potential health risks related to the sound abatement foam component.

GlobeNewswire 06.14.21

Surgical

Aspen Surgical Buys Stork Labor and Delivery Products

Provides a platform for growth in obstetrics and gynecology.

Business Wire 06.14.21

Validant Acquires Greenleaf Health

Greenleaf Chief Executive Patrick Ronan named new CEO of Validant.

Business Wire 06.14.21

Aptar CSP Technologies Earns ISO 13485 Certification

Recognition comes as the company prepares to commercialize a new medical device using its proprietary 3-Phase Activ-Polymer platform technology.

Aptar CSP Technologies 06.14.21

Vivasure Medical First Patient in Study of Next-Gen PerQseal+ Device

Trial will provide investigators with a better understanding of the product's benefits.

Michael Barbella 06.14.21

Feinstein Institutes Scientists Develop Long-Term Vagus Nerve Implant

Research could help advance the field of bioelectric medicine.

Business Wire 06.11.21

Probo Medical Acquires SonoDepot

Deal extends Probo as a coast-to-coast third-party service provider.

Business Wire 06.11.21

NanoVibronix Begins Real World Patient Study of UroShield

Patient recruitment underway; interim results expected in October.

Business Wire 06.11.21

Tubing & Extrusion

Zeus Acquires CathX Medical

Will integrate the catheter-based contract manufacturer.

Zeus Industrial Products Inc. 06.10.21

Patient Monitoring

Nuvo's Remote Uterine Monitoring Earns FDA Nod

Expands clinical utility of INVU by Nuvo platform.

PR Newswire 06.10.21

Cardiovascular | Surgical

FDA Clears Neurescue's Intelligent Balloon Catheter

Cleared for hemorrhage control and IDE approved for cardiac arrest.

Business Wire 06.10.21

Patient Monitoring

Xandar Kardian’s Health Monitoring Radar Gains Clearance

This radar people-counting solution enables continuous and completely autonomous vital sign readings in real-time

Xandar Kardian 06.10.21

Patient Monitoring

FDA OKs Canon Medical's Digital PET/CT for AI-Based Image Reconstruction

Cartesion Prime with AiCE helps clinicians produce high-quality images consistently.

Business Wire 06.10.21

Qosina Expands Class VI Tubing Portfolio for Single-Use Medical Device and Bioprocess Applications

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WINNING THE SPEED

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Cardiovascular | Surgical

Medtronic Reveal LINQ ICM Trial Data Shows Superiority

Demonstrated seven-fold increase in detecting atrial fibrillation vs. standard of care.

Sam Brusco, Associate Editor 06.08.21

Cardiovascular | Surgical

FDA OKs AngioDynamics' AlphaVac Mechanical Thrombectomy System

Non-surgical removal of thrombi or emboli from the vasculature.

Sam Brusco, Associate Editor 06.08.21

Molding

MTD Micro Molding Marks Facility Expansion Opening

Ceremony included unveiling of plaque to honor late president.

Sean Fenske, Editor-in-Chief 06.07.21

Private Equity Group to Buy Medline for Over $30B

Medline will remain a privately held, family-led company.

Sam Brusco, Associate Editor 06.07.21

Global Diabetes Care Devices Market to Garner $39.4B by 2027

The increasing geriatric population is forecast to drive market growth over the next six years.

Michael Barbella, Managing Editor 06.07.21

Katena Products Acquires ASICO LLC

ASICO supplies ophthalmic surgical instruments to healthcare providers.

Michael Barbella, Managing Editor 06.07.21

Intertek Granted ASCA Recognition by FDA for Medical Device Premarket Testing

he ASCA Pilot Program is a voluntary program developed to provide increased confidence in testing results.

Michael Barbella, Managing Editor 06.04.21

Bodyport Names Amit Rushi as Chief Commercial Officer

Phyllis Whiteley, Ph.D., is appointed board chairman.

Michael Barbella, Managing Editor 06.04.21

CeQur Raises $115 Million Series C5 Financing

Money will support the commercialization and scale-up of automated manufacturing for the firm's Simplicity wearable insulin delivery device.

Michael Barbella, Managing Editor 06.04.21

Freudenberg Medical's Dr. Sherry Gray Retires as VP/GM

Gray will be succeeded by Ana Quesada.

Charles Sternberg, Assistant Editor 06.04.21

Cardiovascular | Software & IT

GE Healthcare, ACC Team Up to Advance AI in Cardiac Care

Collaboration will start tackling overwhelming challenges related to AFib management.

Sam Brusco, Associate Editor 06.03.21

3D/Additive Manufacturing

Materialise Acquires Option to Buy Link3D

Potential deal will accelerate roadmap to offer cloud-based access to integrated software platform.

Michael Barbella, Managing Editor 06.03.21

NovaSignal Launches Cerebral Blood Flow Measurement Platform

Product is a unified, AI-driven cerebral ultrasound solution that provides clinicians with evidence to guide patient diagnosis and treatment.

Michael Barbella, Managing Editor 06.03.21

Cardiovascular | Digital Health | Software & IT

FDA Clears Avicenna.AI's Triage Solution for Deadly Vascular Conditions

CINA CHEST detects and supports emergency triage of pulmonary embolism and aortic dissection.

Sam Brusco, Associate Editor 06.02.21

Patient Monitoring

BioBeat Rolls Out Wearable Continuous Ambulatory Blood Pressure Monitoring Device

New clinical data supports use of Biobeat ABPM cuffless-monitor as reliable and accurate solution for out-of-clinic blood pressure monitoring.

Charles Sternberg, Assistant Editor 06.02.21

Will Recent Changes in CMS Rules Sink Us?

As of Jan. 1, CMS started cutting its list of inpatient-only services.

Dawn A. Lissy, Founder & President, Empirical 06.02.21

Chronic Disease | Digital Health

Baxter Launches Sharesource Analytics 1.0 for Dialysis

Digital health module to enhance clinical management of home dialysis patients.

Sam Brusco, Associate Editor 06.02.21

Packaging & Sterilization

STERIS Completes $4.6B Deal for Cantel Medical

Adds infection prevention products and services to STERIS' portfolio.

Sam Brusco, Associate Editor 06.02.21

Chronic Disease

Ibex Medical Analytics Earns CE Mark for Galen Breast Solution

Demonstrates very high accuracy in detecting multiple types of breast cancer in a blinded study.

Charles Sternberg, Assistant Editor 06.01.21

Contract Manufacturing

Resonetics Acquires Distal Solutions

Adds interventional medical device design and development services to Resonetics' portfolio.

Sam Brusco, Associate Editor 06.01.21

Cardiovascular

Abiomed Buys preCARDIA, a Heart Failure Tech Firm

preCARDIA system treats acute decompensated heart failure.

Sam Brusco, Associate Editor 06.01.21

Memic Innovative Surgery Raises $96 Million

Funding will primarily support commercialization of the Hominis surgical robot in the United States.

Michael Barbella, Managing Editor 06.01.21

Double-Digit Growth Predicted for South Korean Renal Dialysis Market

Frequent need for dialysis, adoption of advanced technologies, and development of better home dialysis equipment is expected to drive expansion.

Michael Barbella, Managing Editor 06.01.21

Cardiovascular

Varian's Cardiac Radioablation System Earns Breakthrough Status

Noninvasive therapy currently in development for select refractory ventricular tachycardia patients.

Sam Brusco, Associate Editor 05.28.21

Digital Health

Philips, Ibex Medical Analytics Partner to Accelerate Adoption of AI-Powered Digital Pathology

Combination of Philips’ digital pathology solutions and Ibex’s AI-powered Galen platform has improved reporting efficiency by 27 percent.

Michael Barbella, Managing Editor 05.27.21

amg International Receives CE Mark for Unity-B Biodegradable Stent

Compliments Archimedes, amg’s CE approved pancreaticobiliary biodegradable implant.

Charles Sternberg, Assistant Editor 05.26.21

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Cardiovascular | Surgical

Medtronic Two-Year Evolut Low-Risk TAVR Trial Results Released

Demonstrates hemodynamic advantages of Evolut TAVR System over open-heart surgery.

Sam Brusco, Associate Editor 05.18.21

BD to Build $200 Million Manufacturing Facility in Zaragoza, Spain

Construction of the new plant will begin in late 2021.

Charles Sternberg, Assistant Editor 05.18.21

3M Unveils Silicone Adhesive for People With Fragile Skin

Product is breathable, conformable, enables up to a seven-day wear time, and minimizes skin cell removal.

Michael Barbella, Managing Editor 05.18.21

FDA Clears Nanox's Single-Source Digital X-Ray

Company's technology digitally generates electrons and successfully replaces the thermionic filament ‎in the X-ray tube.

Michael Barbella, Managing Editor 05.17.21

Cardiovascular

Abbott Recalls Assurity, Endurity Pacemakers

Potential moisture ingress is causing electrical shorts and reduced battery life.

Sam Brusco, Associate Editor 05.17.21

Cardiovascular | Surgical

Abbott's Navitor TAVI System Gains CE Mark

The new TAVI system features advancements to reduce or eliminate risk of blood leakage around valve implant.

Sam Brusco, Associate Editor 05.17.21

Electronics

Miniaturizing Linear Motion and Measurement—A Medical Equipment Challenge

A real world example of a successful engineering challenge to develop a smaller, lighter motion control solution.

Christian Meier, Senior Product Manager, SCHNEEBERGER 05.14.21

Diagnostics

BD Announces CE Marked Assay for HPV Screening from At-Home Self-Collected Samples

Affords women greater access to testing.

Charles Sternberg, Assistant Editor 05.14.21

Tech Etch Appoints Brian Roberts as CFO

Roberts brings 25 years of extensive international financial and operational experience.

Charles Sternberg, Assistant Editor 05.14.21

Fresenius Kabi, Corvida Medical Forge Distribution Pact for Drug Transfer Device

Agreement enhances Fresenius Kabi’s offerings in oncology care.

Michael Barbella, Managing Editor 05.14.21

Two Sublime Radial Access Platform Devices Used for First Time in Patients

Surmodics' Sublime Radial Access .014 RX PTA Dilatation Catheter, Sublime Radial Access Guide Sheath deliver solid performance.

Michael Barbella, Managing Editor 05.14.21

Contract Manufacturing

Empowering Connected Medtech Manufacturing Workers

With a worker shortage on the horizon and lessons learned from the pandemic, connected workers could help ease the challenges ahead.

Louis Columbus, Enterprise Software Strategist, DELMIAWORKS 05.13.21

Contract Manufacturing

A Contract Manufacturer Selection Handbook

This article will offer considerations and best practices for selecting the right partner for your medical device development project.

Ashley Turrell, Director of Strategy, Natech Plastics 05.13.21

Digital Health

Empowering Value-Based Care Through Interoperability

EHR interoperability and medical device connectivity enable healthcare providers to meet the shift toward value-based care and reimbursement.

Josh Hetler, Executive Vice President, Business Intelligence, DataLink 05.13.21

MDS Acquires Assets of APS Plastics and Manufacturing

Expands its machining capabilities.

Charles Sternberg, Assistant Editor 05.12.21

Chronic Disease

NXgenPort Enters License Agreement with Mayo Clinic

Collaboration advances the company’s development and product testing efforts.

Charles Sternberg, Assistant Editor 05.12.21

Diagnostics

Olympus Releases New Endobronchial Ultrasound Bronchoscope

The BF-UC190F aids physicians in diagnosing and staging lung cancer without surgery.

Sam Brusco, Associate Editor 05.12.21

Surgical

Olympus Rolls Out Airway Mobilescopes

All-in-one design allows a range of recordable, sharable airway management procedures.

Sam Brusco, Associate Editor 05.12.21

Double-Digit Growth Expected for South Korean Coronary Stents Market

Increase to be driven by improved outcomes of stenting procedures and lower prices.

Michael Barbella, Managing Editor 05.12.21

Contract Manufacturing

Leveraging Your Outsourcing Relationship for Success—A Medtech Makers Q&A

A contract manufacturer should complement the OEM in every step of the product development process, from concept to commercialization.

Alvalux Medical Awarded Patent for Wearable Dermal Repair System

Product helps improve old and prevent new hypertrophic and keloid scar healing.

Michael Barbella, Managing Editor 05.11.21

FDA Grants EUA to Beckman Coulter's COVID-19 Antibody Test

Assay being rolled out in laboratories throughout the New York City metropolitan area.

Michael Barbella, Managing Editor 05.11.21

Europe's Needle-free IV Connectors Market to Top $442.5 Million by 2027

Product approvals and launches are expected to drive growth over the next six years.

Michael Barbella, Managing Editor 05.10.21

Paige Appoints Chief Commercial Officer and Medical Director

Andy Moye has worked in molecular diagnostics, biotechnology and life sciences.

Michael Barbella, Managing Editor 05.10.21

RenovaCare Appoints Interim President and CEO

Kaiyo Nedd, a practicing medical doctor in Canada, will lead the company until a replacement is found.

Michael Barbella, Managing Editor 05.10.21

Patient Monitoring

Medtronic Rolls Out SonarMed Pediatric Monitor

Alerts clinicians to potential airway obstructions during ventilation.

Sam Brusco, Associate Editor 05.10.21

Neurological

Theranica’s Therapeutic Wearable Wins Award

Nerivio was named as the ‘Best New Technology Solution for Pain Management.’

Charles Sternberg, Assistant Editor 05.07.21

Diagnostics

RSIP Vision Launches Prostate MRI-to-Ultrasound Registration Tool

Module creates a warped MRI scan that matches real-time ultrasound results to precisely locate clinically relevant regions & reduce procedural risks to patients

Charles Sternberg, Assistant Editor 05.07.21

Surgical

FDA Approves J&J Vision's TECNIS Synergy, Synergy Toric II IOLs

Next-generation presbyopia-correcting intraocular lens (PCIOL) also approved in Canada.

Sam Brusco, Associate Editor 05.07.21

GORE Reports First Use of the EXCLUDER Conformable AAA Endoprosthesis

Cases successfully performed in Brooklyn, N.Y., and Houston.

Michael Barbella, Managing Editor 05.07.21

Lumendi Introduces its EZ Glide Hydrophilic Coating

The coating is activated by water or saline and improves endoscopic performance of the DiLumen EIP.

Michael Barbella, Managing Editor 05.07.21

Cardinal Health Partners With FourKites to Build Cognitive Supply Chain

FourKites will serve as innovation partner and central data hub for all Cardinal Health shipments.

Michael Barbella, Managing Editor 05.07.21

Chronic Disease | Diagnostics

GE Healthcare Buys Zionexa, a Breast Cancer Dx Startup

Acquired molecular imaging agent aims for more targeted metastatic breast cancer treatment.

Sam Brusco, Associate Editor 05.06.21

Cardiovascular | Patient Monitoring

Abbott Begins Trial for Patients with Simultaneous AFib and Heart Failure

Will use cardiac ablation and sensors to monitor pulmonary artery pressure and abnormal heartbeats.

Sam Brusco, Associate Editor 05.06.21

Chronic Disease

BD to Spin Off Diabetes Care Biz

Transaction is expected to be completed in the first half of 2022.

Sam Brusco, Associate Editor 05.06.21

FDA Approves Helius Medical's Stimulator Device for Gait Improvement

The product is a short-term treatment for gait deficit as a result of mild to moderate symptoms from multiple sclerosis.

Michael Barbella, Managing Editor 05.06.21

PolyVascular Awarded $2 Million Grant to Study Pediatric Heart Valve

Company hires Will Clifton as COO to manage the path to human trials in the United States.

Michael Barbella, Managing Editor 05.06.21

Digital Health

Connect America to Buy Philips' Aging and Caregiving Biz

Combined business will service expanded customer base of Personal Emergency Response System.

Sam Brusco, Associate Editor 05.05.21

Surgical

PENTAX Appoints Former Philips VP Ojas A. Buch as President, Americas

Buch also held leadership roles at GE Healthcare, St. Jude Medical (Abbott), and CareFusion (Yvaire).

Sam Brusco, Associate Editor 05.05.21

Wytech Industries Appoints President

David Ohmann brings 25 years of experience in international, orthopedic, and advanced surgical medical device segments.

Charles Sternberg, Assistant Editor 05.05.21

Strong Growth Forecast for Japan's Assisted Reproductive Tech Devices Market

Government-enacted family-friendly policies and subsidization of female reproductive health methods will help drive the sector's expansion.

Michael Barbella, Managing Editor 05.05.21

Stephanie Fehr Appointed to Invacare Corporation's Board

New addition currently works for UnitedHealthcare and spent nearly two decades at Apple Computer Inc.

Michael Barbella, Managing Editor 05.05.21

NeurOptics Launches Pupillometry Program at Tennessee Hospital

Neurological intensive care unit implements pupillometry as a tool to support management of brain injury patients.

Michael Barbella, Managing Editor 05.05.21

Patient Monitoring

Biobeat Receives CE Mark for AI-Powered Remote Patient Monitoring Platform

Provides continuous vital sign measurement and patient deterioration identification capabilities in hospital and home settings.

Charles Sternberg, Assistant Editor 05.04.21

Study Shows High Safety, Efficacy for Adjustable Thrombectomy Device

Data demonstrate 84.6 percent revascularization success with Rapid Medical’s TIGERTRIEVER.

Michael Barbella, Managing Editor 05.04.21

Outset Medical Appoints Andrea Saia to Board of Directors

New member has focused her 40-year career building leading global brands in the consumer products and medical technology businesses.

Michael Barbella, Managing Editor 05.04.21

Cardiovascular | Surgical

Medtronic's Evolut PRO+ TAVI System Gains CE Mark

PRO+ TAVI System launches with four valve sizes and lowest delivery profile yet.

Sam Brusco, Associate Editor 05.04.21

Surgical

CooperCompanies Buys obp Medical for $60M

Builds on CooperSurgical‘s strong family of OB/GYN medical devices.

Sam Brusco, Associate Editor 05.04.21

Surgical

FDA Clears XPERIENCE No Rinse Antimicrobial Solution

The solution defends against germs for hours and can used in virtually every open surgery case.

Michael Barbella, Managing Editor 05.04.21

Scapa Healthcare - Windsor, CT Scapa Soft-Pro® Silicone Adhesive Coating Capabilities & Services

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Digital Health

How Can a Device End User Aid in Cybersecurity?

MPO's Sean Fenske gets tips from Alan Grau of Sectigo about how a medical device end user, whether physician or patient, can help ensure the unit is secure.

Sean Fenske, Editor-in-Chief

Preparing for the EU’s MDR

As the clock to the deadline is in the final minutes, this article offers a few tips to help ensure companies meet with the requirements.

Nick Tippmann, Vice President of Marketing, Greenlight Guru 04.29.21

Materials

The Plastics Problem—Infection Control vs. Medical Equipment

Due to harsh chemicals, medical device manufacturers need a solution to the problems caused by regular cleaning of healthcare equipment.

Ryan Hoobler, VP of Engineering, Code Corporation 04.29.21

Tubing & Extrusion

Demystifying Multi-Lumen Tubing—A Medtech Makers Q&A

MicroSpec’s Tim Steele shares his expertise on factors to consider when specifying multi-lumen tubing and also reveals common challenges he encounters.

Electronics

EMS Providers Play Key Role in Product Development Amid Pandemic

EMS firms acting as 'a central point' to ensure 'all the pieces come together.'

Michael Barbella, Managing Editor 04.27.21

Cardiovascular

Ceryx Medical Appoints Chas Taylor as Chairman

New leader founded three international cardiovascular businesses.

Michael Barbella, Managing Editor 04.27.21

Neurological

LivaNova, Verily Begin Difficult-to-Treat Depression Study

Verily research tools will evaluate real-world VNS Therapy effectiveness as adjunctive difficult-to-treat depression treatment.

Sam Brusco, Associate Editor 04.27.21

Cardiovascular Systems Acquires Peripheral Support Catheters from WavePoint Medical

Agreement also includes development of portfolio of CTO products.

Michael Barbella, Managing Editor 04.26.21

Device Companies to Help AI Market Reach $52 Billion in 2024

Medtronic and Royal Philips recently invested in AI and machine learning technologies.

Michael Barbella, Managing Editor 04.26.21

LG Expands Diagnostic Medical Monitor Line

Unveils new 12-megapixel multimodality display.

Charles Sternberg, Assistant Editor 04.23.21

Cardiovascular

Getinge Heart Lung Machine Becomes Available for European Hospitals

The HL 40 is designed to increase safety and ensure maximum uptime in cardiac surgery.

Charles Sternberg, Assistant Editor 04.23.21

Digital Health

What Could Medical Device Hacking’s Future Look Like?

MPO's Sean Fenske and Alan Grau of Sectigo discuss potential hacking strategies for future instances of gaining access to medical technology.

Sean Fenske, Editor-in-Chief

Electronics

OEMs Increasingly Choosing EMS Providers Closer to Home

Firstronic CEO notices preference among major device firms to reshore electronics manufacturing.

Michael Barbella, Managing Editor 04.23.21

Patient Monitoring

Cipher Skin's Biomechanics Measuring Mesh

MPO's Sean Fenske speaks with Dr. Shaka Bahadu of Cipher Skin about his measurement mesh and the healthcare applications for it.

Sean Fenske, Editor-in-Chief 04.22.21

Study Shows Benefits of CCHD Screening Using Masimo SET Pulse Oximetry

Prevalence of critical congenital heart disease in the Sri Lankan study was 2.02 per 1,000 live births.

Michael Barbella, Managing Editor 04.22.21

Machining & Laser Processing

Developing Leaders in the Workforce—MPO Videobites

Dax Strohmeyer of Triangle speaks with MPO’s Sean Fenske about the company’s establishment of a program to address the need for future leaders.

Sean Fenske, Editor-in-Chief

Software & IT

Realizing the Value of Today’s Connected Worker—A Medtech Makers Q&A

Connected workers gain an advantage while in the workplace as they can maintain oversight of the systems and projects they are tied to at any moment.

Patient Monitoring

FDA Grants 510(k) Clearance to LivaNova’s B-Capta

An in-line, blood-gas monitoring system integrated into the S5 Heart-Lung Machine.

Charles Sternberg, Assistant Editor 04.20.21

Gynesonics Appoints Susan Stimson to Its Board of Directors

Executive with extensive commercialization experience to provide key insights on global launch strategies.

Michael Barbella, Managing Editor 04.20.21

Electronics

EMS' Engineering Resources Increasingly in Demand

Unpredictable demand, the need to reduce costs, and shorter production lead times driving companies to seek earlier interaction with product engineers.

Michael Barbella, Managing Editor 04.20.21

Cardiovascular

FDA OKs Canon Medical's One-Beat Spectral Cardiac CT

Aquilion ONE / PRISM Edition now offers AI-powered spectral capabilities for cardiac exams.

Sam Brusco, Associate Editor 04.19.21

IZI Medical Products Launches Fully Automatic Quick-Core Auto Biopsy System

Product has three programmable firing modes for tissue sampling.

Michael Barbella, Managing Editor 04.19.21

Seed Grants Awarded to Five Proposals for Pediatric Medical Device Development

Projects address infant feeding development, neonatal jaundice, pediatric dysphagia, unplanned extubations, and adrenal crisis.

Michael Barbella, Managing Editor 04.19.21

Digital Health

Real-World Medical Device Hacking Tales

MPO's Sean Fenske gains some insights from Alan Grau of Sectigo on examples of real-world healthcare device hacking incidents and the details involved.

Sean Fenske, Editor-in-Chief

Iterative Scopes Announces IBD-Focused Scientific Advisory Board

The governing body also will include experts in artificial intelligence.

Michael Barbella, Managing Editor 04.16.21

Electronics

Fiber Optics Introducing New Cleanliness Requirements for Medical Electronics

Devices with high-speed data capabilities and high-resolution video must be rugged enough to withstand OR environment and harsh sterilization methods.

Michael Barbella, Managing Editor 04.15.21

Diagnostics

FDA Grants De Novo Clearance to Medtronic’s GI Genius Model

Assists physicians in detecting pre-cancerous growths, potentially addressing 19 million colonoscopies annually.

Charles Sternberg, Assistant Editor 04.15.21

Acutus Medical Receives FDA Clearance of AcQCross

Product family targets more than 300,000 annual U.S. electrophysiology and structural heart procedures.

Michael Barbella, Managing Editor 04.15.21

Portable Medical Devices Market to Reach $100 Billion by 2027

Sector to grow 8.5 percent annually over the next six years, driven by an increased awareness of overall health and fitness.

Michael Barbella, Managing Editor 04.15.21

Chronic Disease

BD Receives 510(k) Clearance for Pristine Catheter

The clearance was supported by clinical data from a feasibility study with favorable primary patency rates observed out to 180 days.

Charles Sternberg, Assistant Editor 04.15.21

Vicarious Surgical Appoints CFO and Chief Legal Officer

William J. Kelly and June M. Morris have joined the company's executive team.

Michael Barbella, Managing Editor 04.14.21

Nagarro Achieves ISO 13485 Certification

Company's iife sciences and healthcare business unit offers new opportunities in digital disruption and connected medical devices.

Michael Barbella, Managing Editor 04.14.21

MICRO Expands with New Facility in Costa Rica

Increases its cleanroom assembly capacity to better serve its medical device customers.

Charles Sternberg, Assistant Editor 04.13.21

Qosina Announces Expanded Portfolio for Bioprocess Single-use Systems

Qosina is pleased to announce a new extension to their product portfolio, developed specifically for the needs of the single-use bioprocess industry

Cardiovascular

Endologix Acquires PQ Bypass

Gains proprietary Detour platform for percutaneous femoral-popliteal bypass.

Sam Brusco, Associate Editor 04.13.21

Cardiovascular

Elixir Medical Begins Study of Metallic Implant for CAD Treatment

Product is designed to adapt to vessel physiology.

Michael Barbella, Managing Editor 04.13.21

Digital Health

Thinklabs' Digital Stethoscope for Digital Health

MPO's Sean Fenske speaks with Clive Smith of Thinklabs about his digital stethoscope and how it was used during the pandemic.

Sean Fenske, Editor-in-Chief 04.13.21

Why Use a Medical Grade Silicone for Your Components?

...

Software & IT

Three Future Trends and Opportunities in Quality Assurance

As regulated companies, medical device firms must stay abreast of the latest developments to ensure they adopt new protocols to maintain quality assurance.

David Jensen, Staff Writer, MasterControl 04.09.21

Software & IT

Adopting a Data-Driven Quality Model

Employing a data-driven quality model helps you apply quality processes more holistically throughout the organization.

David Jensen, Staff Writer, MasterControl 04.09.21

Cardiovascular

USPTO Issues Patent Covering Hancock Jaffe’s VenoValve

Valve is intended to be surgically implanted in the deep venous system of the leg to treat reflux associated with Chronic Venous Insufficiency (CVI).

Charles Sternberg, Assistant Editor 04.08.21

Viant Completes Expansion of Costa Rica Facility

New capabilities will boost speed to market for complex medical devices.

Charles Sternberg, Assistant Editor 04.08.21

Cardiovascular

Digging into the Cardiac Arrhythmia Monitoring Device Market

The overall market is set to reach an annual valuation of $9 billion by 2026.

Saloni Walimbe, Research Content Developer, Global Market Insights 04.08.21

Contract Manufacturing | R&D & Design

Moving from Concept to Design—MPO Videobites

Mike Schultz of Spectrum Plastics Group speaks with MPO’s Sean Fenske about the Launch Pad Engineering Service the firm offers for medical device manufacturers.

Sean Fenske, Editor-in-Chief

SMC Ltd. Expands Costa Rica Facility

Doubles the current facility, bringing it to 120,000 square feet in the Coyol Free Zone Park in Alajuela, Costa Rica.

Charles Sternberg, Assistant Editor 04.07.21

Berlin Heals' C-MIC Heart Failure Implant Achieves Breakthrough Device Status

Company initiates an early feasibility study in the United States.

Michael Barbella, Managing Editor 04.07.21

Digital Health

Cloud and AI Accelerating Global Medical Imaging Informatics Market

Modern informatics solutions will drive revenue in developed markets, according to Frost & Sullivan.

Michael Barbella, Managing Editor 04.07.21

FreeMind Group Explains Non-Dilutive Funding

MPO's Sean Fenske speaks with Guy Har-Chen of FreeMind Group about non-dilutive funding and the future of digital health.

Sean Fenske, Editor-in-Chief 04.06.21

Grant Issued for Development of 3D-Printed Resorbable Medical Implants

BellaSeno and Fraunhofer Institute for Production Technology are partnering on the innovation.

Michael Barbella, Managing Editor 04.05.21

Philips Survey Reveals COVID-19’s Negative Impact on Sleep Quality, CPAP Use

Seventy percent of people surveyed have experienced one or more new sleep challenges since the start of the pandemic, data show.

Michael Barbella, Managing Editor 04.05.21

Second Sight Aborts Business Combination with Pixium Vision

Pixium said it would take all necessary means—including legal measures—to claim compensation.

Sam Brusco, Associate Editor 04.05.21

Packaging & Sterilization

BD to Invest $65M in Tucson, Arizona Supply Chain Hub

Operations for the final-stage manufacturing and sterilization facility are planned to begin in mid-2022.

Sam Brusco, Associate Editor 04.01.21

Cardiovascular

Cardiovascular Device Market Expands to Tackle Higher Disease Burden

The market is likely to exceed a valuation of $10 billion by 2027.

Vinisha Joshi, Research Content Developer, Global Market Insights 04.01.21

Cardiovascular | Surgical

Home Is Where the Heart (Valve) Is

Artificial heart valve makers reached a number of milestones despite the pandemic’s global squeeze.

Sam Brusco, Associate Editor 04.01.21

Chronic Disease | Digital Health | Patient Monitoring

CGM: Digital Health Meets a Very Large Opportunity

Continuous glucose monitors (CGMs) are one of the most formidable diabetes management tools to be developed in decades.

Maria Shepherd, President and Founder, Medi-Vantage 04.01.21

Surgical

Biomechanical Engineer, Heal Thyself

Choosing a treatment option for spinal disorders can be tricky with extensive knowledge of the industry.

Dawn A. Lissy, Founder & President, Empirical 04.01.21

Molding | Surgical

Optimizing MIM in Medical Device Manufacturing

Metal injection molding (MIM) is a good choice for producing medium- to high-volume medtech parts.

Steve Santoro, Executive Vice President, MICRO 04.01.21

Diagnostics

PPE and Diagnostics: Sourcing Domestically and Speeding Time to Market

With smart onshoring strategies, the medical device industry can collaborate to fix supply chain issues.

Claudio Hanna and Ralph Tricomi , Web Industries 04.01.21

Testing

The Evolution of Chemical Characterization for Medical Devices

Evaluation of biological safety of devices is experiencing some of the most significant changes in history.

Sandi Schaible, Senior Director, Analytical Chemistry and Regulatory Toxicology, WuXi AppTec Medical Device Testing 04.01.21

Digital Health

How Digital Health Fits into the Medtech Mold

Healthcare will need to adopt digital technologies that streamline and enhance connectivity.

Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 04.01.21

Global Supply Chain Wisdom from Coronavirus-Colored Lenses

There are precious pearls of wisdom from this past year that will come in handy during the next “crisis.”

Chris Oleksy, Founder and CEO, Oleksy Enterprises and Co-Founder Next Life Medical; CEO, Emergent Respiratory 04.01.21

Four Considerations When Selling to a Private Equity Fund

A private equity partner can help medtech firms expand into new markets and serve existing clients better.

Bill Hadler and Anisa Mohanty, McDermott Will & Emery 04.01.21

The Reality of Virtual Experiences for Medtech

VR presents a great way to expose doctors and other medical professionals to new technologies.

Sean Fenske, Editor-in-Chief 04.01.21

Surgical

Ethicon Launches Echelon+ Stapler

Increases staple line security and reduces complications in surgery.

Charles Sternberg, Assistant Editor 04.01.21

Diagnostics

BD Gains EUA for Asymptomatic COVID-19 Screening via Rapid Testing

BD Veritor Plus System supports return-to-school and return-to-work programs through serial testing.

Sam Brusco, Associate Editor 04.01.21

Longeviti Launches ClearFit Covers for Brain Surgery Patients

ClearFit Implants can reconstruct the skull and be used as a diagnostic tool.

Michael Barbella, Managing Editor 04.01.21

Diagnostics

Abbott's Rapid COVID-19 Self-Test Receives EUA

Permits asymptomatic, non-prescription, over-the-counter self-use for people with or without symptoms.

Sam Brusco, Associate Editor 04.01.21

Fralock Holdings Acquires Oasis Materials

Third strategic acquisition in 12 months expands Fralock Holdings' solutions across critical industries.

Michael Barbella, Managing Editor 04.01.21

ForSight Robotics Raises $10 Million in Seed Round

Company's platform aims to automate the complex subtleties of ophthalmic surgery with an intuitive, patient-centric system.

Michael Barbella, Managing Editor 04.01.21

Digital Health

Hackers and Home Healthcare Equipment Concerns

MPO's Sean Fenske continues a discussion with Alan Grau of Sectigo about home and mobile healthcare devices and the threat of hackers.

Sean Fenske, Editor-in-Chief

Neurological

Encora's Tremor Reducing Wristband Gains Breakthrough Status

Indicated to provide temporary hand tremor relief in adult essential tremor or Parkinson's patients.

Sam Brusco, Associate Editor 03.31.21

Electronics

Talented Labor Pool a Challenge for EMS Providers

Workers skilled in electrical wiring and installation in medical products can be difficult to find.

Michael Barbella, Managing Editor 03.31.21

Alaxo Airway Stents Establishes Partnership With Portage College

Alliance aims to help support the company's North American growth.

Michael Barbella, Managing Editor 03.31.21

Diagnostics

Diagnosing the IVD Market: An Interview with TEAM Technologies

Chief revenue officer Steve Lents discusses the in-vitro diagnostic market and manufacturing rapid antigen POC COVID-19 tests.

Sam Brusco, Associate Editor 03.30.21

Why Is Manufacturing Demand Increasing for IV Bags?

Many types and sizes of IV bags are in short supply, putting a strain on the industry.

Emily Newton, Editor-in-Chief, Revolutionized 03.30.21

Jabil Healthcare, E3D Collaborate on Drug Delivery Device Tech

Agreement provides Jabil with exclusive license to develop drug delivery device product platform based on E3D mechanical multi-use auto-injector technology.

Michael Barbella, Managing Editor 03.30.21

BDP Reimbursement Delay—Mike on Medtech

Mike Drues and Sean Fenske discuss the causes for the delay in rolling out the four-year reimbursement policy for breakthrough devices.

Sean Fenske, Editor-in-Chief 03.30.21

Cardiovascular

FDA Breakthrough Status Granted to Cook Medical's Zenith Endovascular Graft

ZFEN+ includes up to five precisely located fenestrations to accommodate the visceral vessels.

Michael Barbella, Managing Editor 03.29.21

Ultrasound Stimulation Can Reduce Obesity, Research Indicates

New study is based on the discovery that ultrasound can be used to perform peripheral nerve modulation as a new form of bioelectronic medicine.

Michael Barbella, Managing Editor 03.29.21

Access Vascular Secures $20 Million in Series B Financing

Money will be used to generate post-market data on two commercial devices designed to reduce thrombus accumulation and catheter occlusions.

Michael Barbella, Managing Editor 03.29.21

Harnessing Critical Health Data With Wearable Technology

Optical biosensors could open new doors for front-end patient care.

Robert Newberry and Matthew Rodencal, Sanmina Corporation 03.26.21

Cardiovascular

FDA Approves Medtronic's Harmony TPV for Congenital Heart Disease

Less invasive option to treat pulmonary valve regurgitation for patients with a native or surgically-repaired right ventricular outflow tract.

Sam Brusco, Associate Editor 03.26.21

Digital Health

Home Healthcare and Cybersecurity

MPO's Sean Fenske speaks with Alan Grau of Sectigo about the concerns of cybersecurity for home healthcare equipment and devices.

Sean Fenske, Editor-in-Chief

Software & IT

Using Quality as an Advantage in 2021

Report finds despite pandemic, 79 percent of medical device professionals expect modest or strong revenue growth in 2021.

Jon Speer, Founder, Greenlight Guru 03.25.21

Surgical

Boston Scientific to Pay $189M to Settle Charges Over Surgical Mesh

The company misled consumers about its surgical mesh devices' safety and effectiveness.

Sam Brusco, Associate Editor 03.25.21

Axonics Forges Manufacturing Partnership With Micro Systems Technologies

Companies will produce the newly-developed Axonics non-rechargeable implantable neurostimulator.

Michael Barbella, Managing Editor 03.24.21

Masimo's Rad-G With Temperature Earns CE Mark

Rad-G can be converted from a handheld spot-check device into a continuous monitoring device, in the absence of other multi-parameter monitors.

Michael Barbella, Managing Editor 03.24.21

J&J Executive, CNN On-Air Commentator Appointed to Glaukos Board

With latest additions, the governing body now consists of nine directors.

Michael Barbella, Managing Editor 03.24.21

Tissium Appoints VP of Global Operations

Thierry Darnis brings a deep background as a global leader managing major medical device design and production units at world-class companies.

Charles Sternberg, Assistant Editor 03.23.21

Software & IT

5 Ways Manufacturers Can Improve IoMT Device Security

Manufacturers cannot make development and security mistakes with IoMT devices.

Emily Newton, Editor-in-Chief, Revolutionized 03.23.21

Diagnostics

Optellum Receives FDA Clearance for Virtual Nodule Clinic

Empowers clinicians to make optimal clinical decisions in early-stage lung cancer diagnosis and is now commercially available in the U.S.

Charles Sternberg, Assistant Editor 03.23.21

Chronic Disease

Insulet’s Omnipod 5 Shows Promise in Pivotal Trial

Demonstrated improved clinical outcomes in type 1 diabetes.

Sam Brusco, Associate Editor 03.23.21

Surgical

XACT Robotics' Robotic-Driven Percutaneous Procedures

MPO's Sean Fenske speaks with Chen Levin of XACT Robotics about a self-steering robot for ablation, biopsy, and drug delivery.

Sean Fenske, Editor-in-Chief 03.23.21

Global Medtech Industry Cross-Border M&A Deals Total $4.5B in Q4 2020

The United States topped deal activity.

Michael Barbella, Managing Editor 03.22.21

U.K. Medical Pendant Market to Top $25.5 Million by End of 2027

The increasing incidence of healthcare-associated infections is a major factor fueling the market's growth.

Michael Barbella, Managing Editor 03.22.21

J. Knipper and Company Appoints Chief Financial Officer

New hire has 30 years of diverse experience in accounting, financial management, M&A, and operations.

Michael Barbella, Managing Editor 03.22.21

Cardiovascular | Surgical

CSI Buys Peripheral Support Catheters from WavePoint Medical

Agreement also includes development of portfolio of chronic total occlusion products.

Sam Brusco, Associate Editor 03.22.21

Contract Manufacturing | Molding

Molding Validation Optimization—A Medtech Makers Q&A

PTI’s Steve VanderKooi offers advice to help manufacturers avoid pitfalls and delays to ensure a timely and repeatable validation protocol.

BGF Invests in Vascular Closure Devices Firm

Financing marks BFG's seventh Irish investment in the past two years.

Michael Barbella, Managing Editor 03.19.21

U.S. Safety Needles Market to Top $3.4B by 2028

Favorable government reimbursement for pen needles is expected to help drive the market.

Michael Barbella, Managing Editor 03.19.21

Probo Medical Acquires IMAX Medical

Deal enables IMAX Medical to offer a deeper solution set to suppliers and customers.

Michael Barbella, Managing Editor 03.19.21

Urgotech Unveils Results from Clinical Study of Urgonight

Helped users gain more sleep each night.

Charles Sternberg, Assistant Editor 03.18.21

Chronic Disease

FDA Approves Boston Scientific's TheraSphere Y-90 Glass Microspheres

The only radioembolization treatment approved for U.S. patients with hepatocellular carcinoma.

Sam Brusco, Associate Editor 03.18.21

Olympic Bobsledder Named New Board Chairman at PathogenX

World Cup medalist has spent half his sales and management career in the medical device and healthcare technology sector.

Michael Barbella, Managing Editor 03.18.21

Medtech's Cross Border Venture Financing Deals Top $1B in Q4 2020

The United States led deal activity during the three-month period.

Michael Barbella, Managing Editor 03.18.21

Junkosha Announces Technology Innovator of the Year Award

Celebrates revamped brand image with new corporate logo and website.

Charles Sternberg, Assistant Editor 03.17.21

Hearing Implant Market Value to Expand by $600M This Decade

Sector will be driven by an increasing prevalence of hearing loss among the world's aging populations.

Michael Barbella, Managing Editor 03.17.21

Catheter and Medical Design Acquires VitalDyne Medical Inc.

Provides customers with greater speed, flexibility, and value.

Charles Sternberg, Assistant Editor 03.16.21

Causes, Costs and Cures for Unplanned Downtime

Insights for Medical Device Manufacturers

The Many Hats of an Integrated Contract Manufacturer

and How Each One Fortifies Your Medical Device Supply Chain

Medical Device Supply Chain: At What Stage of a Product’s Lifecycle Should You Bring in a CM Partner

Your contract manufacturing partner can have a dramatic effect on the success (or failure) of your project.

Materials

TISSIUM's Biomorphic Programmable Polymers

MPO's Sean Fenske speaks with Christophe Bancel of TISSIUM about remarkable new materials that can be used to replace human tissue.

Sean Fenske, Editor-in-Chief 03.16.21

Software & IT

Three Reasons Automation and Training Are Essential in Your MDQMS

Having the proper tools in place to ensure all training activities are occurring when and how they should is critical to quality.

Jon Speer, Founder, Greenlight Guru 03.15.21

Testing

NAMSA Appoints New CEO, Board Chairman

Dr. Christophe Berthoux will begin leading the company March 22; former AdvaMed Chairman Nadim Yared to become NAMSA Chairman.

Sam Brusco, Associate Editor 03.15.21

FDA Clears Rhythmlink's New MR Conditional Electrode Portfolio

Sticky Pad Electrode line now boasts MR conditional clearance and CT compatibility.

Michael Barbella, Managing Editor 03.15.21

Four Ways Remote Freelance Experts Can Help Medtech

Changes in the regulatory landscape and working-from-home scenarios reduce the degree of change when working with remote consultants.

Ramya Sriram, Digital Content Manager, Kolabtree 03.15.21

Chronic Disease

FDA OKs Baxter's AK 98 Hemodialysis Machine

Can be used alongside Theranova, Baxter’s novel dialysis membrane.

Sam Brusco, Associate Editor 03.15.21

LifeTech Technology for Life Sciences

Life sciences – smart solutions for medical technology and laboratory automation

CE Mark Granted to ProciseDx for Fecal Calprotectin Point-of-Care Testing

Product will enable GI facilities in Europe to improve and accelerate patient care.

Michael Barbella, Managing Editor 03.12.21

Cardiovascular

Cardinal Health to Sell Cordis Biz to Hellman & Friedman for $1B

Transaction is expected to close in the first half of Cardinal Health's fiscal year 2022.

Sam Brusco, Associate Editor 03.12.21

Cardiovascular

Global Cardiovascular Devices Market to Exceed $62 Billion by 2025

Sector to be driven in part by the robust performance of cardiac assist products.

Michael Barbella, Managing Editor 03.12.21

Testing

Sotera Health Acquires BioScience Laboratories

Strengthens Sotera Health’s antimicrobial and antiviral lab testing capabilities.

Charles Sternberg, Assistant Editor 03.11.21

An Overview of the ASCA Pilot Program

The FDA published a three-part final guidance on the voluntary program.

David Jensen, Staff Writer, MasterControl 03.11.21

Medical Device Cross Border Deal Activity in U.S. Rises in Q4 2020

Venture financing was the industry's leading deal category.

Michael Barbella, Managing Editor 03.11.21

TransEnterix Establishes European Training Center

Netherlands site will provide basic and advanced training on the Senhance Surgical System.

Michael Barbella, Managing Editor 03.11.21

Europe Marks First CellFX Procedures

The cellular-focused CellFX System is designed to clear common benign skin lesions.

Michael Barbella, Managing Editor 03.11.21

Digital Health | Software & IT

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