Impact Analytical

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

CareDx Appoints Hannah Valantine to its Board

Valantine is a professor of Medicine at Stanford and the former National Institutes of Health chief scientific officer for Scientific Workforce Diversity.

Globe Newswire 09.21.21

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

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

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

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

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

SCIEX Debuts the ZenoTOF 7600 System

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

Business Wire 09.02.21

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

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

PartsSource Unveils New Operations Dashboard

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

Business Wire 08.26.21

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

Cardiovascular

Biomedical Engineers Grow 3D Bioprinted Blood Vessel

Paves the way for possible cardiovascular drug advancements with better precision.

Texas A&M Engineering 08.19.21

BD Names Christopher DelOrefice as EVP and CFO

DelOrefice joins the company from Johnson & Johnson.

BD 08.12.21

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

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

Cardiovascular

Study: Human Oversight ECG Monitors Outperform AI-Dependent Monitoring

Results show ECG monitor is over 200 percent more effective in detecting arrhythmias.

Heart Rhythm Society 08.05.21

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

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

Greg Cebular Named as President of Mack Prototype

Cebular brings 18 years of advanced manufacturing and leadership experience to the company.

Mack Molding 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

Phillips-Medisize Unveils Aria Smart Autoinjector Platform

Small and easy-to-use injection device is designed to support medication management.

Phillips-Medisize 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

Cardiovascular | Digital Health

BioFourmis' Digital Heart Failure Therapeutic Earns Breakthrough Status

Augments guideline-directed use of heart failure medications.

PR Newswire 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

Surgical

Baxter Buys CryoLife's PerClot Polysaccharide Hemostatic System

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

Baxter 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

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

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

ONI Welcomes Dr. Tyler Ralston as Chief Technology Officer

Visionary technology creator will help drive future innovations in single cell microscopy applications.

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

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

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

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

Digital Health

Heartbeat Health Raises $20 Million Series B Funding

Money will be used to expand virtual heart care.

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

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

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

Cardiovascular | Surgical

Surmodics Buys Vetex Medical

Adds ReVene Thrombectomy Catheter to the company's portfolio.

Business Wire 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

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

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

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

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

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

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

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

Getinge’s Torin AI Solution Improves Hospital Efficiency

Designed to improve efficiency in managing schedules for surgical procedures and comes in the wake of a new Getinge survey.

Getinge 06.10.21

Top 483s of 2020—Mike on Medtech

Mike Drues and Sean Fenske discuss the issues medical device manufacturers had during inspections last year.

Sean Fenske, Editor-in-Chief 06.08.21

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 | 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

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

Cardiovascular | Patient Monitoring

FDA OKs Edwards' Acumen IQ Cuff Hypotension Prediction Index Software

Uses machine learning to alert clinicians of likelihood a patient is trending toward hypotension.

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

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

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

Cardiovascular

Abbott Recalls Assurity, Endurity Pacemakers

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

Sam Brusco, Associate 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

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

FDA Grants Breakthrough Device Status to Epilepsy Treatment System

NeuroPace's RNS System is currently available in the United States as an adjunctive therapy for adults with drug-resistant focal epilepsy.

Michael Barbella, Managing Editor 05.12.21

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

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

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

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

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 | 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

Diagnostics

CerTest Biotec & BD Add Saliva to the Visasure SARS-CoV-2 Detection Kit

Allows BD MAX System users more flexibility with three alternatives for specimen collection.

Charles Sternberg, Assistant 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

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

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

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.

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

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

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

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

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

Algorithm Can Predict Acute Kidney Injury Sooner Than Hospital Systems

Dascena's machine learning diagnostic can foretell Stage 2 or Stage 3 AKI up to 48 hours in advance.

Michael Barbella, Managing 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

Chronic Disease | Software & IT

Varian, Google Cloud Partner to Bring Convenience to Cancer Therapy

Firms will collaborate to build AI tools for radiation oncology organ segmentation using the Google Cloud AI Platform.

Sam Brusco, Associate Editor 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

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

Chronic Disease | Digital Health | Patient Monitoring

Welldoc, Dexcom Expand Strategic Partnership for Diabetes Management

Companies to integrate CGM, lifestyle management platforms to offer integrated type 2 diabetes solution.

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

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

Surgical

Ethicon Launches Echelon+ Stapler

Increases staple line security and reduces complications in surgery.

Charles Sternberg, Assistant 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

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

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

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

CareSignal Expands its Deviceless Remote Patient Monitoring System

Deloitte collaboration supports healthcare organizations offering virtual patient care.

Michael Barbella, Managing Editor 03.25.21

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

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.

Urgotech Unveils Results from Clinical Study of Urgonight

Helped users gain more sleep each night.

Charles Sternberg, Assistant Editor 03.18.21

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

Reusable device validation

The medical industry is familiar with the use of autoclaves in operating rooms and laboratory settings for sterilization.

Surgical

Memic Receives FDA Marketing Authorization for Hominis

Its robot-assisted surgical platform is now available for use in transvaginal gynecologic procedures including benign hysterectomy.

Charles Sternberg, Assistant Editor 03.02.21

Varian CEO to Retire Following Siemens Healthineers Acquisition

Dow Wilson will be succeeded by Varian president and COO Chris Toth, who will lead Siemens' Varian business segment.

Sam Brusco, Associate Editor 03.02.21

Solid Growth Forecast for Japan's MI Neurosurgical Devices Market

Minimally invasive procedures are preferred over open surgeries due to less exposure to brain structures, rapid recovery time, and less tissue scarring.

Michael Barbella, Managing Editor 03.02.21

OrthogenRx on FDA’s Ambiguity on Hyaluronic Acid

MPO's Sean Fenske speaks with Mike Daley of OrthogenRx about the role HA plays in alleviating knee pain and the challenges with the FDA over it.

Sean Fenske, Editor-in-Chief 03.02.21

Japan to Lead APAC Assisted Reproductive Technology Devices Market

Sector forecast to grow 2.1 percent annually this decade.

Michael Barbella, Managing Editor 02.25.21

South Korean HIV Testing to Reach Peak Market Value This Year

The sector's worth declined in 2020 due to COVID-19's impact in the country.

Michael Barbella, Managing Editor 02.19.21

Cardiovascular

Shockwave Medical’s Sonic Pressure Wave Therapy Receives Pre-Market Approval

Technology approved to treat calcified coronary plaque.

Charles Sternberg, Assistant Editor 02.17.21

FDA Appoints its First Cybersecurity Director

University of Michigan associate professor to serve a one-year term within the Center for Devices and Radiological Health.

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

SpectraWAVE Announces $13.2 Million Series A-2 Financing

Funds will accelerate the development of its intracoronary imaging technology and support a regulatory filing.

Michael Barbella, Managing Editor 02.16.21

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

Cardiovascular

Optimize EP Is Optimizing Remote Electrophysiology Monitoring

MPO's Sean Fenske speaks with Dr. Maninder Bedi and Ravi Kartan of Optimize EP about the level of efficiency their technology offers.

Sean Fenske, Editor-in-Chief 02.09.21

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

Endo Tools Therapeutics Secures 8 Million Euros in Series D Funding

The company plans to seek regulatory clearance in the U.S. and reimbursement in European countries.

Michael Barbella, Managing 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

India's NIPT Testing Market Driven by Demand for Non-Invasive Genetic Assessments

Not surprisingly, the market lost value last year due to COVID-19.

Michael Barbella, Managing Editor 01.29.21

Diagnostics

Spectrum Solutions Collaborates with UCLA School of Dentistry

Commences study on using saliva in early lung cancer detection and analysis.

Charles Sternberg, Assistant Editor 01.27.21

Inogen to Undergo Leadership Transition

Longtime BD exec Nabil Shabshab succeeds retiring Scott Wilkinson as president and CEO.

Sam Brusco, Associate Editor 01.27.21

Asia-Pacific Advanced Wound Management Market to Undergo Robust Expansion

The market is being driven by a global aging population, increasing patient awareness levels, and rising disposable incomes.

Michael Barbella, Managing Editor 01.27.21

Cretex Companies CEO Steps Down

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

Charles Sternberg, Assistant Editor 01.22.21

Endoscopic Hemostasis Devices Market Valued at $730 Million

Value has driven by the recent approval of new devices.

Michael Barbella, Managing Editor 01.22.21

Neurent Medical Closes $25 Million Series B Financing

Supports the expansion of the company’s clinical and commercial operations.

Charles Sternberg, Assistant Editor 01.21.21

CHF Solutions Appoints CEO

Nestor Jaramillo Jr succeeds John Erb.

Globe Newswire 01.19.21

Patient Monitoring

Unique Contact Lens Sensor System & Manufacturing Process Developed

New multifunctional lens can provide diversified signals from eyes.

Surrey University 01.12.21

Researchers Receive Funding to Develop Smart Vaccine Device

New smart patch will deliver the COVID-19 vaccine and measure its efficacy through monitoring the body's associated response.

Swansea University 01.12.21

Patient Monitoring

CES News: Philips Highlights Healthcare at Home

Participates in the first-ever all-digital CES 2021.

Royal Philips 01.11.21

Sera Prognostics Partners with Anthem and HealthCore

Aims to improve outcomes for preterm babies.

Globe Newswire 01.08.21

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

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

Steady Growth Expected for APAC Sterilization Market Through 2030

A robust waste management strategy is needed, however, as the use of plastic-based single-use devices has increased.

GlobalData 01.05.21

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

Medtronic’s Mike Coyle to Lead iRhythm

Current president and CEO Kevin King to retire; change effective January 12, 2021.

iRhythm Technologies Inc. 12.16.20

CorVent, Siemens Healthineers Ink RESPOND-19 Ventilator Distribution Deal

U.S. agreement expands Siemens Healthineers respiratory care portfolio to include critical care ventilators.

PR Newswire 12.16.20

Cardiovascular

Pandemic May Hinder Growth in Peripheral Drug-Coated Balloon Market

Percutaneous transluminal angioplasty balloon procedures declined by almost 30 percent in 2020.

GlobalData 12.15.20

Finding the Upside to a Challenging Year

Despite its complete transfiguration of modern life, COVID-19 had important lessons to teach the medtech industry.

Michael Barbella, Managing Editor 12.11.20

Home Oxygen Therapy to Drive Oxygen Concentrators Market Growth in India

Last year, portable oxygen concentrators accounted for more than 60 percent of the country's oxygen concentrators market.

GlobalData 12.09.20

Patient Monitoring

Talking Medtech with TrueFuture's Joe Mullings

MPO's Sean Fenske speaks with Joe Mullings, medtech recruiter and host of TrueFuture, about what’s got him excited in the medtech space.

Sean Fenske, Editor-in-Chief 12.08.20

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

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

RSNA News: Royal Philips Introduces Patient Management System

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

Royal Philips 11.30.20

Six Percent Growth Predicted for APAC Neurovascular Thrombectomy Devices Market

Medtronic is the leading player in the region, according to market data.

GlobalData 11.24.20

Software & IT

GE Healthcare Launches X-ray AI for COVID-19 Patients' Endotracheal Tube Placement

A necessary and important step when ventilating critically ill COVID-19 patients.

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

Patient Monitoring

CE Mark Granted for Automated Glycemic Control and Continuous Diagnostics System

PrecisionOne provides automated glucose regulation and real-time analysis of blood chemistry values for critical care patients.

PR Newswire 11.23.20

Diagnostics

GE Healthcare Pioneers Photon Counting CT with Prismatic Sensors Buy

Gains Deep Silicon detector technology for photon counting computed tomography (PCCT).

Business Wire 11.20.20

Thirteen Percent Revenue Shortfall Expected in Capsule Endoscopes Market

Market was down nearly 60 percent in Q2 as COVID-19 forced the cancellation or postponement of elective procedures.

GlobalData 11.19.20

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

Vygon, Oncomfort Partner to Commercialize Virtual Reality Pain Relief Device

The collaboration will provide patients with a new personalized treatment option for medical interventions.

Vygon 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

Software & IT

BD Acquires CUBEX's Medical Business

Broadens automated dispensing portfolio across care continuum.

PR Newswire 11.12.20

Harvard Professor Joins ExThera Medical Board

New member is recognized as a leading authority on competitive strategy, the competitiveness and economic development of nations and regions.

Business Wire 11.05.20

The Lost Year: 2020 Year in Review

Lessons learned from the global coronavirus pandemic.

Michael Barbella, Managing Editor 11.04.20

Cardiovascular

The Heart of the Matter: Trends in Cardiology

Of the three major segments of coronary stents, bioabsorbable stents are expected to have the highest growth between now and 2022.

Maria Shepherd, President and Founder, Medi-Vantage 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

Congress Examines Additional COVID-19 Relief and Recent Regulatory Changes

The legislative year is nearly coming to a close as Washington survives yet another tumultuous election cycle.

Jeffrey J. Kimbell, Eric P. Juhl, JD and David C. Rudloff, Jeffrey J. Kimbell & Associates Inc. 11.04.20

Diagnostics

How COVID-19 is Reshaping the Diagnostics Testing Sector

The short-term impact on the diagnostics sector is readily apparent as the pandemic has fueled overwhelming demand for effective SARS-CoV-2 testing solutions.

Eric Williams, Managing Director, Capstone Headwaters 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

Neurological

Salvia BioElectronics' Neurostim System for Chronic Migraine Earns Breakthrough Status

Bioelectronics solution addresses drug-refractory chronic migraine.

PR Newswire 11.03.20

Pandemic to Reduce Global Robotic Surgery Systems Market Revenue by Nearly 8 Percent

A second wave of new COVID-19 cases might generate further delays in elective procedures.

GlobalData 11.03.20

Electronics

Addressing the Non-Magnetic Inductor Need in Medical Electronics

A proprietary non-magnetic material developed by Gowanda Electronics provides inductance qualities.

Michael Barbella 11.03.20

Diagnostics

Imec Developing Five Minute COVID Test

Approach will use virus particles in exhaled breath to identify positive cases and confirm contagion risk.

Imec 10.30.20

Cardiovascular

AngioDynamics Launches Auryon Atherectomy System in the U.S.

Product uses solid-state laser technology for the treatment of peripheral artery disease.

Business Wire 10.28.20

Supply Chain Study Offers Insights on Medtech Recovery

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

Supplyframe 10.22.20

First Patients Treated in Trial for Liver and Pancreas Sealant Patch

The patch is optimized to significantly reduce fluid leakage during the critical healing period after hepato-pancreato-biliary procedures.

B3C Newswire 10.22.20

Diagnostics

New Tech Diagnoses Sickle Cell Disease in Record Time

Only requires a power source, a microscope and a camera.

University of Colorado Boulder 10.19.20

Cardiovascular | Patient Monitoring

3M Littmann Stethoscopes, Eko Initiate New Partnership

Will marry 3M Littmann stethoscope technology with advanced Eko digital innovations.

Business Wire 10.19.20

Considerations in Designing 'Fail-Safe' Motor Drive Circuits

Products must be constructed to fail in a safe manner to protect both patients and physicians.

Michael Barbella, Managing Editor 10.15.20

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

Electronics

Capacitor Considerations for Medical Applications

Careful selection of even the smallest electronic components can make a significant difference in a device’s capabilities.

Rich Bestafka, Key Account Manager—Medical, Knowles Precision Devices 10.12.20

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

Materials