Focus 42 LLC

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

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

RedDress’ ActiGraft System Receives New FDA Clearance

ActiGraft Ver.02 System is intended for the safe and rapid POC preparation of an in-vitro blood clot.

Globe Newswire 09.22.21

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

Surgical

Olympus Corporation Launches Powerseal Advanced Bipolar Surgical Energy Products

Deliver consistent sealing reliability in an ergonomic, multifunctional design that promotes procedural efficiency.

Olympus Corporation 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

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

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

Paragonix Launches Global Registry for Studying Donor Lung Preservation

Registry will capture data on how organ preservation and transportation impact patient outcomes in lung transplantation.

Business Wire 09.20.21

Diagnostics

FDA Clears Inova Diagnostics' Digital Multi-Analyte System

The product, Aptiva, received CE marking in August 2020.

PR Newswire 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

Indago Announces $10 Million Financing Close and Name Change

Lazurite Holdings is developing technology to create the operating room of the future.

Business Wire 09.15.21

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

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

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

Glytec Appoints Nausheen Moulana as Chief Technology Officer

Engineering and technology veteran to lead company’s product vision and support growing demand for insulin dosing software.

Business Wire 09.09.21

908 Devices Develops New Data Integrations With Key Industry Partners

Integration of Sartorius SIMCA and Securecell Lucullus PIMS with REBEL Spent Media Analyzer allows for data-driven decisions.

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

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

Roche's COVID-19 Molecular Test Granted EUA

First test authorized for use in screening, testing asymptomatic and symptomatic individuals with results within 20 minutes.

PR Newswire 09.02.21

SCIEX Debuts the ZenoTOF 7600 System

System delivers new capabilities for life science research and biotherapeutic development.

Business Wire 09.02.21

Bright Future Ahead for Renal Denervation

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

GlobalData 09.02.21

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

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

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

AdaptHealth Appoints Stephen Griggs as CEO

New leader founded AeroCare in 2000.

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

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

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

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

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

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

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

Diagnostics

BD Launches FACSymphony A1 Benchtop Cell Analyzer

Brings sophisticated flow cytometry capabilities to laboratories of all sizes.

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

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

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

Materials

Pandemic has Accelerated Nearshoring Medtech Materials

Buying materials from overseas may be cost-effective, but it can create an environment with less collaboration and less room for innovation.

Michael Barbella, Managing Editor 08.06.21

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

Patient Monitoring

LifeSignals Inc. Receives FDA Approval for Remote Monitoring Platform

The LX1550 Platform can be used by clinicians for the continuous collection of patient physiological data at home and in healthcare settings.

LifeSignals Inc. 08.05.21

ASTM International, NSERC HI-AM Network Sign MOU

The agreement will support the development of additive manufacturing standards.

ASTM International 08.05.21

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

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

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

Cardiovascular | Patient Monitoring

Abbott Rolls Out Jot Dx Insertable Cardiac Monitor

Device has option to control the amount of electronic data received for irregular heart rhythms.

Abbott Laboratories 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

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

Patient Monitoring

FDA OKs LifeSignals' LX1550 Multiparameter Remote Monitoring Platform

Delivers continuous remote patient vital signs monitoring in both hospital and home.

PR 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

3D/Additive Manufacturing | Molding

Metal Injection Molding and Metal 3D Printing Examination

Both MIM and metal AM serve as alternative options to machining for medtech manufacturers requiring metal components.

Mark Crawford, Contributing Writer 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

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

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

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

Substantial Growth Predicted for Global Ventilators Market

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

Market Study Report 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

Digital Health

Heartbeat Health Raises $20 Million Series B Funding

Money will be used to expand virtual heart care.

Business Wire 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

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

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

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

MPE Inc. Expands Into EMEA Market

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

PR Newswire 07.06.21

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

OnLume Surgical Completes $7 Million Series A Financing

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

Business Wire 07.01.21

Ultra-Fast COVID-19 Antibody Test Under Development

Test could be used worldwide to help prioritize who should receive coronavirus vaccines.

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

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

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

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

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

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

Glytec Raises $21 Million for R&D, Product Innovation

Glytec’s eGlycemic Management System is proven to reduce low blood sugar by 99.8 percent and 30-day readmissions by 36-68 percent.

Business Wire 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

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

Summit Partners Invests in Veranex

Investment will form a concept-to-commercialization medtech services company.

Veranex 06.21.21

Baxter Receives Grant to Lead Extracorporeal Blood Purification Research

Company will focus on enabling more selective approaches for certain extracorporeal blood purification therapies.

Business Wire 06.18.21

CE Mark Granted for Biostable Science's HAART 200 Device

More than 1,000 patients now treated worldwide with the HAART Aortic Annuloplasty product.

Business Wire 06.18.21

Spectrum Plastics Group Buys KCS Plastics Ltd.

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

Spectrum Plastics Group 06.15.21

QIAGEN Launches Technology to Triple COVID-19 Lab Testing Capacity

The innovation integrates sample preparation and detection in a single kit, enabling throughput of more than 670 tests per PCR cycler in an eight-hour shift.

Business Wire 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

Validant Acquires Greenleaf Health

Greenleaf Chief Executive Patrick Ronan named new CEO of Validant.

Business Wire 06.14.21

Software & IT

How Digitization Enables Safe, Connected Operations in Manufacturing

In a post-pandemic world, it’s time for companies to address the weaknesses revealed from the experience.

David Butcher, Staff Writer, MasterControl 06.08.21

Neurological

FDA Approves Medtronic's SenSight Directional Lead System for DBS

Directional lead system enables precision, personalization, and enhanced patient comfort.

Sam Brusco, Associate Editor 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

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

Cardiovascular | Patient Monitoring

AliveCor Buys CardioLabs, an Independent Dx Testing Firm

Sets stage for launch of advanced ambulatory monitoring services.

Sam Brusco, Associate Editor 06.03.21

Chronic Disease

Medtronic Receives CE Marks for InPen and Guardian 4 Sensor

New portfolio of diabetes products will launch in Europe later this year.

Charles Sternberg, Assistant 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

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

Software & IT

Four Considerations for Manufacturers When Applying Digitization

The pandemic illustrated the importance of going digital, but some manufacturers still have to make the switch.

David Butcher, Staff Writer, MasterControl 06.01.21

Contract Manufacturing

Maintaining Quality in the Fast-Paced Contract Manufacturing Industry

A cautionary tale from pharma offers lessons to device manufacturers about the dangers of a quality system that isn’t digital.

Dale Thompson, Staff Writer, MasterControl 05.27.21

Validation - What's Your Level?

...

SWM International Completes Acquisition of Scapa Group Plc

Scapa Expands SWM’s Capabilities and Enhances Long-Term Growth Profile

Teleflex to Sell Respiratory Assets to Medline for $286M

Divestments include oxygen and aerosol therapy, active humidification, non-invasive ventilation, and incentive spirometers.

Sam Brusco, Associate 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

Quidel Granted EUA to Market COVID-19 Antigen Test

Assay provides results in 15 minutes and s now available without a prescription.

Michael Barbella, Managing Editor 05.17.21

Hologic Launches Project Health Equality

Aims to address the barriers that prevent Black and Hispanic women in the U.S. from receiving the same quality health care as white women.

Charles Sternberg, Assistant Editor 05.17.21

Neurological

Rice Researchers Seek to Create an Implant That Controls the Body’s Circadian Clock

Could halve the time it takes to recover from jet lag and similar disruptions to the body's sleep/wake cycles.

Charles Sternberg, Assistant Editor 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

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

Scott Dunbar Named Acting CEO of Second Sight Medical Products

Temporary leader has been with the company nearly 20 years.

Michael Barbella, Managing Editor 05.14.21

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

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

Materials

Swedish Researchers Develop Material That Prevents Infections in Wounds

New hydrogel works against all types of bacteria, including antibiotic-resistant ones.

Charles Sternberg, Assistant 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.

Diagnostics

Medtronic’s Pillcam and GI Genius—A Medtech Matters Podcast

MPO's Sean Fenske speaks with Giovanni Di Napoli of Medtronic about the company’s diagnostic technologies they are offering for the gastrointestinal space.

Sean Fenske, Editor-in-Chief 05.11.21

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

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

Chronic Disease | Digital Health

Glooko, Eli Lilly Begin Connected Insulin Pen Collaboration

Will integrate Lilly's Tempo Pen and Tempo Smart Button with Glooko's platform.

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

QIAGEN Granted EUA for its 4-Plex COVID-19 Test

The assay can detect and differentiate influenzas A and B, respiratory syncytial virus (RSV), and COVID-19 infections within 80 minutes.

Michael Barbella, Managing Editor 05.06.21

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

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

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

Spectrum Plastics Group Acquires Laser Light Technologies

Advances the group’s offerings as a full-service partner for medical devices, life sciences, and other applications.

Charles Sternberg, Assistant Editor 05.03.21

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

Diagnostics

Hillrom Advances Its Physical Assessment Tools

Launches the Welch Allyn PanOptic Plus Ophthalmoscope and MacroView Plus Otoscope.

Charles Sternberg, Assistant Editor 04.29.21

Diagnostics | R&D & Design

5 Guidelines for Productizing an Optically Based Medical Device

Pitfalls most relevant to optical medical devices, but many are applicable to medical devices without optics.

Brian King, Principal Optical Systems Engineer, StarFish Medical 04.29.21

BD Names Elizabeth McCombs as CTO

Also announces the creation of an external Scientific Advisory Board.

Charles Sternberg, Assistant Editor 04.28.21

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

Surgical

Medtronic, Surgical Theater Partner for AR Platform in Cranial Procedures

SyncAR integrates with StealthStation S8 Surgical Navigation System for augmented reality (AR) platform.

Sam Brusco, Associate 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

Optimize EP Upgrades Software to Better Manage Patient Data

Upgrade adds another layer of information physicians can use to make more informed diagnostic decisions for cardiac device patients.

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

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

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

Cardiovascular

Riva Health Raises $15.5 Million for Breakthrough Mobile Cardiology Technology

Menlo Ventures, UCHealth invest to bring comprehensive hypertension measurement and management to the phone.

Michael Barbella, Managing Editor 04.20.21

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

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

Cardiovascular | Software & IT

BioSig Launches Software Update for PURE EP Electrophysiology Platform

The upgrade includes enhanced signal processing for advanced cardiac signal analysis.

Sam Brusco, Associate Editor 04.14.21

Surgical

Katena Acquires Ophthalmic Surgical Instrument Maker ASICO

Katena obtains high-quality ophthalmic surgical instruments.

Sam Brusco, Associate Editor 04.14.21

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

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

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

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

Olympus Corporation Opens Facility in Westborough, MA

Will serve as the global headquarters for its Therapeutic Solutions Division and its medical business in the U.S.

Charles Sternberg, Assistant Editor 04.08.21

J&J Vision, Menicon Begin Myopia Contact Lens Making Partnership

The firms aim to bring forward a portfolio of products and services to manage myopia progression in children.

Sam Brusco, Associate 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

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

Samsara Vision, Medevise Consulting Forge European Partnership

Pair will collaborate to advance clinical research, coordinate reimbursement, and drive sales, marketing, and customer relationships.

Michael Barbella, Managing Editor 04.05.21

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

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

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

Tubing & Extrusion

Transporting Treatment: An Examination of Tubing Technologies

OEMs rely on tubing providers to move media and electrical current through the channels via multilumen solutions and extrusion technologies.

Mark Crawford, Contributing Writer 04.01.21

Surgical

Ethicon Launches Echelon+ Stapler

Increases staple line security and reduces complications in surgery.

Charles Sternberg, Assistant Editor 04.01.21

Materials

Outward Appearance: Reviewing Surface Treatment Options

Surface modifications and coatings imbue medical devices with a slew of valuable properties.

Sam Brusco , Associate Editor 04.01.21

Contract Manufacturing | Software & IT | Testing

Quality & Regulatory Solutions for the FDA Regulated Industries

EMMA International specializes in full-circle solutions for the medical device, biologics, and pharma industries.

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

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

Philips Debuts AI-Enabled CT Workflow Solution

Precise Suite on the Incisive CT platform aims to help drive diagnostic confidence and improve the patient and staff experience.

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

Solid Growth Forecast for Australian Implantable Ports Market

Market is partially driven by the increasing prevalence of cancer and availability of advanced treatment options.

Michael Barbella, Managing Editor 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

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

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

Neurolief's Brain Neuromodulation Technology Cleared by FDA for Migraine Treatment

Relivion is the only non-invasive multi-channel neuromodulation technology for the treatment of acute migraine.

Michael Barbella, Managing Editor 03.25.21

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

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.

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

Catheter and Medical Design Acquires VitalDyne Medical Inc.

Provides customers with greater speed, flexibility, and value.

Charles Sternberg, Assistant Editor 03.16.21

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

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

Software & IT

2021: The Year for Insights Into Quality Data

For users of paper-based quality systems, data can seem overwhelming and disorganized.

Sarah Beale, Staff Writer, MasterControl 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

3M Bags Contract from Michigan Medicine for AI-Powered Clinician, Revenue Cycle Tech

Solutions aim to help Michigan Medicine reduce physician stress, bolster thorough clinical documentation.

Sam Brusco, Associate Editor 03.10.21

Digital Health

Market for Virtual Critical Care Solutions to Nearly Double

With critical care becoming increasingly data intensive, companies will need to collaborate with cloud solutions providers.

Michael Barbella, Managing Editor 03.09.21

Virginia School of Medicine Dean Appointed to Baxter's Board

Former Owens-Illinois CEO to serve as lead independent director.

Michael Barbella, Managing Editor 03.09.21

Neurological

Abbott Releases NeuroSphere Virtual Clinic for Remote Neuromodulation Care

Patients can communicate with a physician and remotely receive stimulation settings in real-time with a web connection.

Sam Brusco, Associate Editor

Cretex CFO Announces Retirement

Scott Lunger will succeed Steve Ragaller as CFO.

Charles Sternberg, Assistant Editor 03.05.21

Diagnostics

EchoNous Expands Its Kosmos Hardware Platform

Adds continuous wave and pulsed wave Doppler capabilities.

Charles Sternberg, Assistant Editor 03.04.21

FDA Making Progress With Technology and Data Action Plans

There is an urgent need to get advanced technologies into the healthcare ecosystem, but all products must first get regulatory approval.

Alan Rencher, Vice President, Engineering, MasterControl 03.04.21

Plastikos Medical Begins Phase II of Expansion

Will more than double the size of its current ISO-7 cleanroom.

Charles Sternberg, Assistant Editor 03.03.21

Diagnostics

Quidel's QuickVue At-Home COVID-19 Test Earns EUA

Easy-to-use at-home test provides results in ten minutes with a doctor’s prescription.

Sam Brusco, Associate Editor 03.02.21

FDA Clears Ava Fertility Tracking Wearable Device

The wearable is clinically proven as effective as LH tests in predicting ovulation—and with more fertile days detected.

Michael Barbella, Managing Editor 02.26.21

First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System

The product received CE Mark approval in January.

Michael Barbella, Managing Editor 02.26.21

Portescap Slotless Brushless DC Motors Receive ISO 13485 Certification

Meet the highest quality standards for manufacturing.

Charles Sternberg, Assistant Editor 02.25.21

Cardiovascular

FDA Breakthrough Device Designation Given to MI Transcatheter Heart Pump

Puzzle Medical Device's ModulHeart helps patients avoid open-heart surgery and reduces blood trauma.

Michael Barbella, Managing Editor 02.25.21

FDA Approves Daytime Treatment for Sleep Apnea and Snoring

Signifier Medical’s proprietary therapy eXciteOSA is the first and only daytime genioglossal (tongue) muscle-neurostimulation technology approved in the U.S.

Michael Barbella, Managing Editor 02.23.21

Surgical

FDA Green Lights EPI's EndoClot Hemostat to Manage GI Bleeding

Rapidly and reliably controls bleeding during GI procedures.

Sam Brusco, Associate Editor 02.23.21

Apple iPhone 12 Magnet Can Deactivate Implantable Cardiac Devices

Doctors say manufacturers and implanting physicians should inform patients about the potentially dangerous magnet-implantable cardiac device interaction.

Michael Barbella, Managing Editor 02.23.21

Smart Healthcare Products Market to Nearly Double in the Next Decade

An increasing focus on mHealth, remote patient monitoring, and the use of data for disease diagnosis is expected to drive the growth.

Michael Barbella, Managing Editor 02.23.21

Diagnostics

Rice University Researchers Receive Funding to Develop Covid-19 Sensor System

Real-time electronic system will be able to detect minute amounts of SARS-CoV-2.

Charles Sternberg, Assistant Editor 02.22.21

Trademark Plastics Inc. Partners with MedAccred

Reaffirms its commitment to complete quality assurance.

Charles Sternberg, Assistant Editor 02.19.21

Bicuspid Aortic Stenosis Treatment to Create Huge Market Potential for TAVR Devices

Up to 53 percent of adult patients with diagnosed severe aortic stenosis are estimated to have bicuspid valve anatomy.

Michael Barbella, Managing Editor 02.18.21

FDA Clears Pulse Biosciences' CellFX System

The product delivers Nano-Pulse Stimulation technology in dermatologic procedures.

Michael Barbella, Managing Editor 02.17.21

4 Trends Driving Medical Manufacturing in 2021

Manufacturers across the sector had to manage disruptions last year, but economists say recovery may begin soon.

Emily Newton, Editor-in-Chief, Revolutionized 02.16.21

Qosina and EcoVadis Set to Improve Supply Chain Sustainability for Medical, Pharma and Beauty

Qosina Corp. has partnered with EcoVadis, the world’s most trusted provider of business sustainability ratings

Diagnostics

Hologic’s Breast Health Happenings

MPO's Sean Fenske speaks with Jennifer Meade of Hologic about the company’s recent M&A as well as its initiatives in women’s health.

Sean Fenske, Editor-in-Chief 02.16.21

Diagnostics | Digital Health | Software & IT

Pioneering AI Solutions to Reinforce Healthcare Services

Can AI live up to its hype in the healthcare landscape?

Sunil Jha, Senior Research Content Developer, Global Market Insights 02.12.21

Cardiovascular | Neurological

Cerus Endovascular's Contour Neurovascular System Gains Breakthrough Status

Indicated for the treatment of intracranial aneurysms.

Sam Brusco, Associate Editor 02.12.21

Digital Health

Evolving Trends in the Medical and Orthopedic Devices Industry

There are a number of areas worth keeping an eye on within medtech in 2021 and beyond.

Jacqueline Trovato, Healthcare/Legal Writer 02.09.21

Diagnostics

Rapid Medical Diagnostic Kits Market Size Worth $23.04 Billion By 2027

A desire to provide rapid disease treatments is driving the market's growth.

Michael Barbella, Managing Editor 02.09.21

Surgical

Apollo Endosurgery to Welcome New Leader

Charles (Chas) McKhann will become CEO of the company on March 1.

Sam Brusco, Associate Editor 02.08.21

SteriPack Names New President & CEO

Andrew McLean brings over 20 years of medical device and pharmaceutical expertise.

Sam Brusco, Associate Editor 02.05.21

R&D & Design

Pandemic-Level Playing Field: How COVID-19 Made Space for Progress

Pandemic restrictions may have diminished certain advantages large companies hold over small and mid-sized competitors.

Dawn A. Lissy, President & Founder, Empirical 02.03.21

Contract Manufacturing

Use Vertical Integration to Increase Productivity, Drive Innovation

The concept of vertical integration is simple: a company combining two or more stages of production that would normally be operated by separate companies.

Ryan Lipe, Senior Vice President of Sales & Marketing, MGS 02.03.21

Perspectives on Post-Pandemic: Expect Supply Chain Security to Increase

Dr. Mark Ostwald of Freudenberg Medical speaks to the changes to the supply chain as well as the benefits realized in communication options.

Dr. Mark Ostwald, President—Minimally Invasive Solutions and Europe, Freudenberg Medical 02.03.21

Testing

Element Material Technology Acquires Avomeen

Strengthens its life sciences business unit in North America.

Charles Sternberg, Assistant Editor 02.03.21

Surgical

J&J Granted FDA Approval for Monofocal IOL

TECNIS Eyhance and TECNIS Eyhance Toric II IOLs help treat cataract patients.

Sam Brusco, Associate Editor 02.03.21

A Blueprint for Reducing Medtech Industry's Carbon Footprint

Global warming impact of “single-use” medical devices can be halved by using reprocessed products.

Michael Barbella, Managing Editor 02.03.21

Pulse Biosciences Granted CE Mark Approval for CellFX System

Product delivers nano-pulse stimulation technology to clear hard-to-treat benign skin lesions.

Michael Barbella, Managing Editor 02.03.21

Stericycle Settles Environmental Violations at Its Medical Waste Incinerator

Agreement includes Supplemental Environmental Project to provide low-emitting school buses to local school district.

Michael Barbella, Managing Editor 02.01.21

Cardiovascular | Surgical

Edwards Releases 5-Year RESILIA Tissue Aortic Valve Study Data

There were no incidences of structural valve deterioration at the five-year mark.

Sam Brusco, Associate Editor 02.01.21

Patient Monitoring

Hillrom Buys EarlySense's Contact-Free Continuous Monitoring Tech

EarlySense's contact-free continuous monitoring, analytics tech was integrated into the Centrella Smart+ med-surg bed.

Sam Brusco, Associate Editor 02.01.21

Global Ventilators Market to Reach $1.6 Billion by 2030

But the sector is forecast to experience a downturn this year.

Michael Barbella, Managing Editor 02.01.21

Additive Manufacturing Center of Excellence Welcomes New Advisory Board Additions

The new members represent a cross-section of industry, government, research institutions, and non-profit agencies.

Michael Barbella, Managing Editor 01.29.21

Kwivik Therapeutics, EirMed Partner to Accelerate Product Commercialization

Kwivik has developed a pipeline of products for certain respiratory, emergency medical, asthma, migraine/cluster headache, wound care, and skin care markets.

Michael Barbella, Managing Editor 01.27.21

FDA Clears 3D Acellular Dermal Matrix

The technology is supported by more than 150 peer-reviewed published articles.

Michael Barbella, Managing Editor 01.27.21

QT Imaging Signs Distribution Agreement With Freedom Ventures for Breast Scanner

Transmission ultrasound breast imaging now to become available in EMEA markets.

Michael Barbella, Managing Editor 01.25.21

MedAcuity, Fathom Partner on Human Factors Engineering Services

Focused on facilitating safe and effective use of medical devices, HFE is a critical aspect of product development.

Michael Barbella, Managing Editor 01.25.21

Cretex Companies CEO Steps Down

Jeff Wollerman will succeed Lynn Schuler as CEO of the company.

Charles Sternberg, Assistant Editor 01.22.21

CHF Solutions Appoints CEO

Nestor Jaramillo Jr succeeds John Erb.

Globe Newswire 01.19.21

CMS Expedites Breakthrough Device Access; Industry Applauds

New rule creates an accelerated Medicare coverage pathway for innovative products that the FDA deems ‘breakthrough.’

MPO Staff 01.13.21

Materials

Momentive Performance Materials Acquires KCC Corp.’s Silicones Business

Further strengthens its global capabilities in advanced silicones.

PRNewswire 01.11.21

Cardiovascular

Acutus Medical Launches AcQCross Transseptal System in Europe

The product is designed to improve safety and efficiency in any procedure requiring left heart access.

Globe Newswire 01.08.21

VivaLNK Expands its Medical Data Platform

The platform boasts more than 90 healthcare solution partners across 22 countries amid an increase in remote patient monitoring adoption.

VivaLNK 01.07.21

Greenlight Guru and Nelson Labs Partner

Alliance helps customers mitigate risk and go to market faster.

Greenlight Guru 01.06.21

Packaging & Sterilization | Surgical

Olympus Releases ScopeLocker Endoscope Storage Cabinet

HEPA hinged door endoscope storage system addresses infection prevention needs in busy GI suites.

Olympus 01.06.21

Chronic Disease | Diagnostics

Hologic to Buy Cancer Test Maker Biotheranostics for $230M

Accelerates Hologic’s entry into the oncology growth market, provides new lab capabilities.

Business Wire 01.06.21

Impact of COVID-19 on the Medtech Supply Chain

Agility, reliability, and resiliency all describe objectives of a company’s supply chain management system.

Joe McBeth, Vice President, Global Supply Chain, Jabil 12.16.20

Cardiovascular | Diagnostics

Genetesis' CardioFlux Imaging Tech Gains Breakthrough Status

Leverages room temperature magnetometers to noninvasively measure heart’s naturally-generated magnetic fields.

Business Wire 12.16.20

New CEO Named at Alpha Source Group

Company expands customized service solutions to focus on OEM partnerships.

Alpha Source Group 12.15.20

Diagnostics

FDA, EU Nods for POC Testing on Siemens Healthineers' epoc NXS Host Mobile Computer

Provides critical test results at the point of care in less than a minute.

Siemens Healthineers 12.15.20

Surgical

Olympus Adds 3D, IR, Novel Light Tech to MIS Imaging Platform

Expanded VISERA ELITE II surgical imaging capabilities may help reduce costs, improve efficiency.

Olympus

Preparing Your Design Controls for FDA Approval

Design controls are a set of procedures to build into medical device design and development.

Adam Freeman, Freelance Medical Device and Combination Product Design Specialist, Kolabtree 12.09.20

Diversified Plastics Appoints Engineering Manager

New executive has nearly 30 years of experience serving in leadership positions in a range of industries.

Diversified Plastics Inc. 12.09.20

Sofwave Medical Granted CE Mark for Skin Tightening, Wrinkle Reduction Device

Company's device also received regulatory approval from the Medical Device Division of the Israeli Ministry of Health.

PR Newswire 12.09.20

Chronic Disease

Medtronic Launches Pediatric/Neonatal Acute Dialysis Machine

The Carpediem system is designed to treat patients requiring renal replacement therapy weighing between 2.5 and 10 kilograms (5.5 to 22 pounds).

PR Newswire 12.08.20

Materials

DURECT to Sell LACTEL Absorbable Polymer to Evonik for $15M

Expands Evonik's position as a global CDMO for drug delivery solutions.

PR Newswire 12.08.20

Survey Finds On-Site Inspections Plummeted by 93 Percent

Findings from Greenlight Guru survey reveal internal divides within organizations are making medical device companies less competitive.

Greenlight Guru 12.08.20

MedAcuity Partners With Loft to Support the Full MedTech Product Development Lifecycle

Companies will focus on designing hardware and software that acts in harmony in a single diagnostic or wearable medical device or system.

MedAcuity 12.08.20

Diagnostics

CRISPR-Based COVID-19 Test Uses Smartphone Camera

The rapid, one-step mobile test could help combat the pandemic and fully reopen communities.

PR Newswire 12.07.20

Digital Health

Expert Roundup: Achieving Success in the 2021 Medical Device Landscape

Industry experts share their advice on factors medical device manufacturers need to consider for the coming year to stay ahead.

Nick Tippmann, Vice President Of Marketing, Greenlight Guru 12.04.20

Molding

Tooling Precision is Key to Micromolding Success

Tool quality dictates part quality for all sizes of medical components.

Michael Barbella, Managing Editor 12.03.20

Motion Dynamics Acquires ViaMed Holdings

Enables Motion Dynamics to provide a broader range of capabilities, products, and services.

Motion Dynamics LLC 12.03.20

Patient-Level Data Confirm Safety Profile of Stellarex Low-Dose, Drug-Coated Balloon

No difference in mortality between patients treated with Philips' Stellarex drug-coated balloon and those treated with percutaneous angioplasty.

Royal Philips 12.03.20

Cardiovascular

LivaNova to Sell Heart Valve Biz to Gyrus Capital for $73M

Enables company to sharpen its focus within primary platforms, neuromodulation and cardiovascular.

Business Wire 12.03.20

Wytech Industries Names Henry Burmeister as CFO

Complex specialty core wire manufacturer adds to its management team.

Wytech Industries 12.02.20

Foxx Life Sciences Appoints SVP of Global Sales and Business Development

Mark Robillard brings industry knowledge and experience in all facets of the life science tools industry.

Foxx Life Sciences 12.01.20

Spectrum Plastics Group Acquires PeelMaster Medical Packaging Corporation

...

Surgical

Galen Robotics' Robotic Surgery Subscription Concept

MPO's Sean Fenske speaks with Bruce Lichorowic of Galen Robotics about the firm’s unique subscription plan for its robotic surgery system.

Sean Fenske, Editor-in-Chief 12.01.20

RSNA News: Royal Philips Introduces Patient Management System

Offers personalized care to patients during the COVID-19 pandemic.

Royal Philips 11.30.20

Chronic Disease

Increasing Comfort for Chemotherapy Patients

Leveraging a freelance researcher in bringing the Chemo Mouthpiece to market—A case study.

Ramya Sriram, Digital Content Manager, Kolabtree 11.24.20

Cardiovascular

VitalConnect Lanches VitalPatch RTM Cardiac Monitoring Solution

Monitors for 21 cardiac arrhythmias through a unique AI-based ECG analysis solution and captures data on four key vital signs.

Business Wire 11.23.20

Advanced NanoTherapies Raises $5.3 Million in Seed-Round Financing

Company accelerates development of its nanoparticle-based drug delivery technology platform to treat peripheral artery disease and other applications.

Business Wire 11.23.20

Chronic Disease | Patient Monitoring

FDA OKs Baxter's Homechoice Claria with Sharesource

Sharesource is a two-way remote patient management platform for patients on peritoneal dialysis.

Business Wire 11.23.20

Femtech Firm Launches Two-in-One Medical Device to Help Women With Conception

A $1.5 million seed accelerates manufacturing and shipping; app is updated to incorporate user feedback.

PR Newswire 11.23.20

Surgical

FDA Clears Penumbra's Lightning 12 Aspiration Catheter for Pulmonary Embolism

Indigo Aspiration System with Lightning 12 removes these difficult-to-access, life-threatening clots.

Business Wire 11.20.20

Chronic Disease

Varian Begins First Human Trial of FLASH Therapy for Cancer

ProBeam particle accelerator was modified to enable radiation therapy delivery at ultra-high dose rates.

PR Newswire 11.20.20

Molding

Miniaturization of Medical Devices Creating Big Assembly Challenges

Extremely tight tolerances leave no room for error.

Michael Barbella, Managing Editor 11.20.20

Graham Partners Acquires Teamvantage, CMD, Paradigme

Will provide operational resources to foster a strong growth trajectory for the companies.

Teamvantage 11.19.20

Global Neurovascular Devices Market to Surpass $3.18 Billion by 2027

Product launches are expected to help drive the market's growth.

Business Wire 11.19.20

Sommetrics' aerSleep II Sleep Apnea Treatment Earns Breakthrough Designation

aerSleep II applies negative pressure over the external surface of the neck to hold airway open during sleep.

Business Wire 11.17.20

Diagnostics | Patient Monitoring

Digital Radiology Ushering Innovations in the Medical Imaging Market

Radiology is on the cusp of revolution following the soaring popularity of digital radiography.

Sunil Jha, Research Content Developer, Global Market Insights 11.17.20

FDA Agrees to Participate in MDIC's Collaborative Community Initiative

Effort is designed to help advance medical device quality and safety to achieve better patient outcomes.

Business Wire 11.17.20

Foldax Strengthens its Scientific and Medical Advisory Boards

Company adds two new members to each of the governing bodies.

Business Wire 11.17.20

Cardiovascular | Surgical

Boston Scientific Recalls, Discontinues LOTUS Edge Aortic Valve

Voluntary recall is related solely to the delivery system.

PR Newswire 11.17.20

R&D & Design

How Design Controls Can Prevent Medical Device Recalls

Incorporating risk management early in development will help eliminate problems before they impact the product’s manufacturing lifecycle.

Ramya Sriram, Digital Content Manager, Kolabtree 11.16.20

Indago Appoints President and General Counsel

New leader has 15 years of experience in the life sciences industry.

Business Wire 11.16.20

RenovaCare CEO is Elected Board President

Chief executive assumed role in November 2019.

Globe Newswire 11.16.20

Chronic Disease

Wrighting the MiMedx Ship: An Exclusive Interview

In this interview with the firm’s new CEO, MPO discovers what’s been done to turn the page on the company’s troubled past.

Sean Fenske, Editor-in-Chief 11.13.20

Chronic Disease

Medtronic Launches InPen with Real-Time Guardian Connect CGM Data

Real-time glucose data coupled with InPen’s dose calculator helps users make better dosing decisions.

Medtronic plc 11.12.20

Surgical

OnLume Surgical Awarded $2 Million Grant to Develop Fluorescence-Guided Surgery Device

The company's FGS imaging technology illuminates critical anatomy in real-time during surgery to optimize precision.

Business Wire 11.12.20

Software & IT

BD Acquires CUBEX's Medical Business

Broadens automated dispensing portfolio across care continuum.

PR Newswire 11.12.20

Patient Monitoring

Prevounce Health Launches Remote Patient Monitoring Module

The module combines digital spirometry, smart nebulizers, and pulse oximetry.

PR Newswire 11.10.20

Diagnostics

Smartphone-based Solutions Boost Infectious Disease POC Testing Market 70.2 Percent

Study reveals that digital POC platforms will enable diagnostic testing beyond the clinic, transforming how assay results are gathered and analyzed.

Frost & Sullivan 11.10.20

R&D & Design

Collaborating with Full-Service Design and Development Providers—A Medtech Makers Q&A

Spectrum Plastics Group’s Paul Melnychuck speaks about the advantages of working with a full-service supplier and contract manufacturer.

Electronics

Big Data's Role in Sensor Design

Insight into device use is driving trends in miniaturization, low-power options, and conversion to digital sensing.

Michael Barbella, Managing Editor 11.09.20

Syneo Acquires Integrated Medical Holdings

Expands the equipment, tooling, and service offerings of the combined companies.

Syneo 11.06.20

HeartHero Inc. Awarded ISO 13485 Certification

Company to continue regulatory path for AED in collaboration with the American College of Cardiology.

Business Wire 11.05.20

Chronic Disease

Pharmaceutical Focus: A Look at Combination Products

Combination products and drug delivery devices aid in patient compliance and a movement toward point-of-care at home.

Mark Crawford, Contributing Writer 11.04.20

3D/Additive Manufacturing

The Printed World: Additive Manufacturing in Medtech

Medical additive manufacturing experts discuss key factors impacting the market both during and post-pandemic.

Sam Brusco, Associate Editor 11.04.20

Virtually the Same? The Challenges of Online Conferences

Like everyone else on the planet, I’m turning increasingly to virtual solutions to our physical challenges in the midst of a pandemic.

Dawn A. Lissy, Founder & President, Empirical 11.04.20

Quality Assurance When Supply Chain Disruptions Arise

From supply chain disruptions to impromptu manufacturing modifications, the medical device industry has faced a whirlwind of complications in 2020.

Sandi Schaible and Peter Steen, WuXi AppTec Medical Device Testing 11.04.20

The Top 30 and M&A in 2021: What’s Next?

With three of the top five companies appointing new CEOs in the last year and the global pandemic eroding earnings, M&A strategies could look a lot different.

Florence Joffroy-Black and Dave Sheppard, MedWorld Advisors 11.04.20

COVID 19: Supply Chain Professionals’ Ultimate Reality Challenge

Having been a part of the medtech supply chain for 40 years, I can say there has never been a more difficult time for supply chain professionals.

Chris Oleksy, Founder and CEO, Oleksy Enterprises and Next Life Medical; CEO, Emergent Respiratory 11.04.20

keepMED Raises Funding for Regulatory Clearance of its Sleep Apnea Device

Company's technology mobilizes the user’s respiratory system to deliver just the amount of PAP needed, intermittently and with minimal airflow.

Business Wire 11.04.20

Philips Releases BiPAP A40 EFL Non-Invasive Ventilator

Expands its home care portfolio for COPD patients.

GlobeNewswire 11.04.20

Former Medtronic, St. Jude Executive Assumes CCO Role at JenaValve

Company is pursuing FDA pre-market approval for its Pericardial TAVR System.

Business Wire 11.04.20

OmniVision Expands Medical Image Signal Processor Family for Endoscopes and Catheters

Two new additions to the OVMed ISP product line increase options for greater design flexibility and rapid integration into medical devices.

OmniVision Technologies Inc. 11.03.20

Cardiovascular

FDA Approves Boston Scientific's Ranger Drug-Coated Balloon

Drug-eluting stent and drug-coated balloon treats patients with peripheral artery disease.

PR Newswire 11.03.20

Digital Health

How AI Is Improving Predictive Analytics in Healthcare

Predictive analytics and artificial intelligence can enable a more efficient pathway to a better treatment protocol.

Thomas Lanigan, Technical Writer 10.30.20

Surgical

MMI Launches Symani Surgical System

Advances robotic microsurgery with the smallest wristed surgical instruments.

MMI 10.28.20

Neurological

First-Ever Treatment Shown to Reverse Alzheimer’s Earns Breakthrough Status

Revolutionary clinical-stage head device to beat back Alzheimer’s disease at home.

Business Wire 10.28.20

NeuroMetrix Issued New U.S. Patent for Quell Wearable Technology

The patent covers core Quell technology that regulates electrical stimulation.

Globe Newswire 10.28.20

Solid Growth Expected for Global Intraoperative Monitoring Electrodes Market

Sector is forecast to expand 7.1 percent annually through 2027.

Coherent Market Insights 10.28.20

Global Central Venous Catheter Market to Surpass $3.06 Billion by 2027

The increasing prevalence of cancer and end-stage renal disease is fueling market growth.

Business Wire 10.26.20

Cardiovascular

CoreMap Completes $10.5 Million Series A Financing

Round led by Qure Ventures will accelerate development of CoreMap’s technology to enable curative, patient-specific treatment of atrial fibrillation.

Globe Newswire 10.23.20

Global Coronary Stents Market to Exceed $15.1 Billion by 2027

Increase is being driven by the rising incidence of cardiovascular diseases, strategic collaborations and acquisitions among key players.

Business Wire 10.23.20

Quasar Medical Devices Expands Headquarters

The company also announces a number of hirings of key personnel.

Quasar Medical Devices LLC 10.22.20

Supply Chain Study Offers Insights on Medtech Recovery

Concerns remain about data accuracy, distribution, surge-related delays, and shortages.

Supplyframe 10.22.20

PENTAX Medical Launches J10 Series Endoscopic Ultrasound Gastroscopes in the U.S.

The gastroscopes provide a lightweight and ergonomic control body design to ensure stability and ease of intubation while reducing hand fatigue.

PR Newswire 10.22.20

Summit Medical, Practico Solutions Develop Tracking Module for Robotic Instrument Reprocessing

Medical device manufacturer responds to recent FDA guidance update to ensure hospital compliance.

Business Wire 10.22.20

Miracor Medical Raises 24 Million Euros

Funds will be used for clinical studies and initiation of PiCSO commercialization.

Business Wire 10.14.20

Cutera Launches truSculpt flex in Canada

Product treats up to eight areas simultaneously, covering the largest area in the body sculpting industry.

Business Wire 10.14.20

ArchiMed Acquires Majority Interest in NAMSA

Investment to accelerate NAMSA’s global growth and strategic vision.

Business Wire 10.14.20

Cardiovascular | Surgical

Medtronic Begins TAVR Study Comparing Evolut Against Edwards' Sapien Valve

Also begins feasibility study of Evolut in moderate and asymptomatic aortic stenosis patients.

PR Newswire 10.14.20

7 Steps to Create Your Own Medical Device Marketing Plan

A successful strategy will result in increased leads while saving time and money.

Robert Jordan, Media Relations Manager, InfoClutch Inc. 10.09.20

Electronics

Connected Health Driving Demand for Comprehensive Electronics Solutions

Medical electronics must be designed to handle the increased bandwidth, high-speed interconnects inclusive of fiber optics, and high signal integrity and speed.

Michael Barbella, Managing Editor 10.09.20

Packaging & Sterilization

Brenda Chamulak named President of Tekni-Plex Packaging Products

Comes from Jabil Packaging Solutions where she was CEO, SVP and president.

Tekni-Plex 10.08.20

Randall Sword Named CEO of Catheter and Medical Design

Joins following his previous position as president and CEO of N2 Biomedical.

Catheter and Medical Design LLC 10.07.20

CE Marking Received for Osprey Medical's DyeVert Power XT Device

Second-generation device is expected to be a core product in the product portfolio being commercialized by GE Healthcare.

Business Wire 10.05.20

Contract Manufacturing | Electronics

Innovation, Miniaturization are Top Priorities for Electronic Components Manufacturers

But many companies are hesitant to start new development projects while the coronavirus is still rampant.

Michael Barbella, Managing Editor 10.05.20

Digital Health

AdvaMed Proposes Modernized CMS Policies for Digital Health

AdvaMed CEO Whitaker calls on CMS to “eliminate bureaucratic obstacles” to digital health.

AdvaMed 10.02.20

Former Guidant CEO Named AdvaMed Lifetime Achievement Award Recipient

Ron Dollens was named CEO when the company spun out from Eli Lilly to form the standalone firm.

AdvaMed 10.01.20

National Pediatric Medical Device Competition Announces Six Winners

Winning devices in virtual pitch event on track to advance pediatric cardiovascular, NICU, and orthopedic and spine device innovations.

National Capital Consortium for Pediatric Device Innovation 10.01.20

Molding

Little Big Parts: Micromolding Under the Microscope

Minimally invasive surgery, device miniaturization, and age-related conditions are increasingly driving the need for micromolded medtech components.

Michael Barbella, Managing Editor 10.01.20

Contract Manufacturing

Expediting Time to Market—A Medtech Makers Q&A

Donatelle’s Mike Kaiser and Todd Owens provide insights on speeding up development to get products out to market more quickly.

Contract Manufacturing

Innovation and Expertise Drive Evolution in Medical Device Manufacturing

MICRO’s president offers a look at the company his family founded 75 years ago as well as the industry it’s supported.

Brian Semcer, President, MICRO 09.29.20

Software & IT

Adopting a Data-Driven Approach to Quality with an MDQMS

FlexLogical is making quality a competitive advantage through its software solution.

Jon Speer, Founder and VP of QA/RA, Greenlight Guru 09.24.20

Software & IT

FDA OKs Varian's Eclipse v16.1 Proton Therapy Treatment Planning Software

Integration of Dual Energy CT images in planning process reduces range uncertainty and helps clinicians spare healthy tissue.

PR Newswire 09.16.20

Beaufort CRO Names Senior VP of Regulatory and Quality

Industry thought leader and veteran strategist to lead the further expansion of global regulatory and quality services.

Business Wire 09.11.20

NextPhase Medical Device Announces New CCO

Industry veteran, Robert Olsen, named chief commercial officer for the company.

NextPhase Medical Devices 09.10.20

STEWART Industries Launches Medical Device Division

Company will manufacture, source, and supply medical products and PPE on a national scale.

Globe Newswire 09.09.20

Korean Ophthalmic Medical Device Developer Launches U.S. Subsidiary

Three-year-old company developed a surgical endoilluminator with a chopping function for cataract surgery.

PR Newswire 09.01.20

Facts to Ensure MDR Success

Even with the delay of the European Union’s MDR deadline until May 26, 2021, the race to reach compliance is still on for medical device manufacturers.

Sherry Parker, Ph.D. and Bob Pryzgoda, Ph.D. 09.01.20

Electronics

Disruptive Medical Device Cybersecurity Solution

A new technology offers a different approach to cybersecurity for implantable devices.

Daniel L. Greene, Ph.D., COO, and James M. Hair III, Ph.D., CSO—Tueor Technologies 08.27.20

Diagnostics

QIAGEN to Launch Digital, Portable COVID-19 Antibody Test

Access Anti-SARS-CoV-2 is an easy-to-use 10-minute test on a portable device that provides highly accurate results on Total Ig antibodies.

QIAGEN 08.26.20

Software & IT

Areas to Consider in Medical Device Risk Management

How to ensure the production of safe and effective medical devices.

Jon Speer, Founder and VP of QA/RA at Greenlight Guru 08.24.20

SaaS Solution Introduced for Guided Compliance in Medtech Product Development

Cognition Corporation's solution is designed to automate the product development process in compliance with industry standards.

PR Newswire 08.24.20

Diagnostics

FDA Clears Siemens Healthineers AI-Based Software

New assistants free radiologists from routine activities during MRI examinations.

Siemens Healthineers 08.20.20

Florida Medical Device Symposium

...

08.03.20

MED-EL is First Hearing Implant Producer to Earn MDR Certification

Delayed by one year, the MDR will apply to all manufacturers selling medical devices within Europe.

MED-EL 08.03.20

McGill, Montreal General Hospital Foundation, & HeroX Launch ‘Made for All’ Challenge

Invite thousands of innovators to develop an affordable ventilator.

PRNewswire 07.28.20

Software & IT

Haemonetics Sheds Blood Bank, Hospital Software Subsidiary Inlog

Inlog was sold to French private equity firm Abénex.

PR Newswire 07.24.20

NCC-PDI Announces Winners of COVID-19 Medical Device Competition

Judges awarded grants for eight medical devices that address COVID-19-related needs.

Children's National 07.22.20

Diagnostics

Study Shows AI Software is Comparable to Radiologists in Triaging Suspected COVID-19

CAD4COVID was developed and validated by two Dutch companies using 24,678 chest X-ray images.

Thirona 07.21.20

R&D & Design

‘COVID-19-Edition’ of Medical Device Competition Announces Finalists

Winners will receive grant awards of up to $50,000.

Children's National 07.13.20

Annual Pediatric Medical Device Competition Reveals 10 Finalists

Cardiovascular, NICU, and orthopedic and spine device innovators gain access to a new pediatric accelerator.

National Capital Consortium for Pediatric Device Innovation 06.30.20

How Are MPO’s Top 30 Addressing COVID-19?

J&J's Janssen moves the start of its Phase 1/2a vaccine clinical trial from September to the first half of July.

Sam Brusco, Associate Editor 06.09.20

Packaging & Sterilization

Six Key Design Features to Ensure Medical Device Packaging Meets ASTM D4169

Well-thought-out packaging is an oft-delayed but essential part of ensuring a medical device operates safely and effectively in the field.

Nigel Syrotuck, Mechanical Engineering Team Lead, StarFish Medical 06.04.20

Minerva Surgical Acquires Boston Scientific Intrauterine Health Products

Combines the Minerva Endometrial Ablation System with the Genesys HTA Endometrial Ablation System.

PRNewswire 05.12.20

Molex Welcomes New SVP and President

Paul Chaffin joins the company from a Minnesota-based Fortune 500 company.

Phillips-Medisize. 05.12.20

Cardiovascular

HRS 2020 Science: Mobile VPG Technology Used to Monitor Pulse Rates

New study shows AI-based facial recognition can enable patient mobile devices to detect AF.

Heart Rhythm Society 05.08.20

Sporting Goods Brand Now Making Millions Of Face Masks

Company will donate face masks to those in need including hospice workers, nursing homes, assisted living facilities, and first responders.

StringKing 04.27.20

GlobalData: Medtronic’s MI Business to Exhibit Slow Growth

Aliyah Farouk, Medical Device Analyst at GlobalData offers her view.

GlobalData 04.24.20

Diagnostics

Siemens Healthineers to Expand SARS-CoV-2 Testing

With a demonstrated sensitivity and specificity of more than 99 percent, the test is expected to exceed the stringent FDA quality guidelines.

Siemens Healthineers 04.23.20

Cardiovascular

VisCardia's Heart Failure Therapy Gains Breakthrough Designation

Designed for the treatment of heart failure with reduced ejection fraction and preserved ventricular synchrony.

NewsWire 04.23.20

The Medtech Supply Chain and COVID-19

How are service providers and component suppliers adjusting to life during a pandemic to ensure they maintain quality?

Sean Fenske, Editor-in-Chief 04.22.20

Medtronic Sees Revenue Losses Due to COVID-19 Pandemic

The company says it is well positioned for recovery.

Globe Newswire 04.22.20

Diagnostics

FDA Clears Siemens Healthineers' Aidan AI

The latest technology enables new features and enhanced security.

Siemens Healthineers 04.22.20

Itamar Medical to Evaluate Impact of CPAP Therapy on Patients with COVID-19

The clinical trial will assess the efficacy of CPAP in COVID-19 confirmed or suspected patients.

Globe Newswire 04.22.20

Terumo's Mirasol Shows Efficacy Against Virus Causing COVID-19 in Plasma, Platelets

The pathogen reduction system is designed to add an extra layer of safety to the blood supply.

Terumo BCT 04.20.20

Diagnostics

bioMérieux Revenue Will Continue to Grow, Says GlobalData

New COVID-19 respiratory panel test is currently in development.

GlobalData 04.20.20

Contract Manufacturing | Diagnostics

AdvaMed's Scott Whitaker on Medtech's COVID-19 Response

MPO Editor-in-Chief Sean Fenske speaks with Scott Whitaker, AdvaMed President and CEO, about how the medtech industry is assisting in the COVID-19 effort.

Sean Fenske, Editor-in-Chief 04.17.20

Baxter’s Q1 Earnings Forecasted to Increase, GlobalData Says

Job postings triple as demand increases.

GlobalData 04.17.20

EU’s Parliament Adopts MDR Delay of One Year

Would allow authorities and manufacturers to prioritize the fight against COVID-19 if member states approve delay.

European Parliament 04.17.20

Molding

Vaupell Midwest Earns MedAccred Accreditation for Plastic Injection Molding

MedAccred is an oversight program designed to provide manufacturing supply-chain oversight for OEMs looking to partner with Contract Manufacturers.

Vaupell Midwest 04.16.20

Patient Monitoring

PulseCam Maps Blood Flow

New Rice U. tech could let doctors monitor blood perfusion in real time with a camera.

Rice University 04.13.20

Tolomatic Develops Open-Source, Ventilator Actuation Prototypes

The proposed technologies are the first step in creating innovative emergency ventilators for patients around the world.

Tolomatic 04.13.20

Industry Events Schedule Disrupted Due to Coronavirus—Full Event List

The medical device manufacturing industry has seen the postponement or cancellation of a number of upcoming events.

Sean Fenske, Editor-in-Chief 03.30.20

R&D & Design

Rice Joins U of U-Led Human Factors Consortium

Brings new expertise to the consortium, led by University of Utah.

University of Utah 03.30.20

Medtronic Shares Ventilator Design Specifications

The company aims to accelerate efforts to increase global ventilator production amid COVID-19.

Medtronic 03.30.20

FDA Grants Lucid Diagnostics Breakthrough Device Designation for Esophageal DNA Test

Test is designed to facilitate the diagnosis of Barrett’s Esophagus, with and without dysplasia.

Globe Newswire 03.30.20

Battelle Develops Decontamination System for Medical Protective Equipment

Organization receives FDA emergency use authorization to reprocess previously worn PPE.

Business Wire 03.30.20

Neil Tween Joins Owlstone Medical

Neil Tween appointed as Chief Financial Officer.

Owlstone Medical 03.30.20

Packaging & Sterilization

EtO Sterilization Concerns—Mike on Medtech

Mike Drues and Sean Fenske discuss the controversy surrounding the most commonly used sterilization method for medical devices—EtO.

Sean Fenske, Editor-in-Chief 03.30.20

Drug/Device and Device/Drug Combinations in the EU and USA

...

01.02.20

MedDevice MedTech Compliance Congress

...

01.02.20

Contract Manufacturing

Ask the Right Questions when Choosing a Contract Manufacturer

The selection process for a new supply partner can be challenging if you don’t know what to ask about.

Mike Fritschy, Vice President, Engineering and Product Development, SMC Ltd. 11.26.18

Software & IT

6 Best Practices for Complying with ISO 13485:2016

At this stage, companies have less than six months to be compliant.

Jon Speer, Co-Founder and VP of QA/RA, Greenlight Guru 10.17.18

With Trump’s Space Force Idea Gaining Steam, Could a U.S. Health Force Be Far Behind?

...

Chris Oleksy, Emergent Respiratory 10.16.18

Cardiovascular | Surgical

Merit Medical Buys Cianna Medical for Up to $200M

Cianna Medical is a leader in wire-free breast localization and has been focused on breast conservation for 11 years.

GlobeNewswire 10.02.18

Meddux Development Receives ISO 13485:2016 Certification

Firm offers engineering design and development of interventional and minimally invasive surgical devices.

Meddux Development Corporation 09.24.18

R&D & Design

The Impact of Changing Healthcare Economics on Device Design

...

Tony Freeman, President, A.S. Freeman Advisors, LLC 09.07.18

Clinical Innovations Acquires French Company MVF Disposables

Deal strengthens global growth strategy and European presence.

Clinical Innovations 09.05.18

Cardiovascular

CHLA/USC Researchers Design Novel Micropacemaker

The researchers team up to design and implant a minimally-invasive device in area around the heart.

Business Wire 08.09.18

Packaging & Sterilization | Surgical

Hoya's Pentax Medical Acquires Majority Stake in PlasmaBiotics SAS

PlasmaBiotics is a company focused on the ultra-fast channel drying and active storage of endoscopes.

PR Newswire 08.01.18

14. B. Braun

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07.26.18

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