Simbex

Tubing & Extrusion

Zeus Acquires CathX Medical

Will integrate the catheter-based contract manufacturer.

Zeus Industrial Products Inc. 06.10.21

Patient Monitoring

Xandar Kardian’s Health Monitoring Radar Gains Clearance

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

Xandar Kardian 06.10.21

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

Ronkonkoma, NY, USA, June 9, 2021

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

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

Michael Barbella, Managing Editor 06.07.21

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

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

Cardiovascular | Digital Health | Software & IT

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

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

Sam Brusco, Associate Editor 06.02.21

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

Contract Manufacturing

Resonetics Acquires Distal Solutions

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

Sam Brusco, Associate Editor 06.01.21

Memic Innovative Surgery Raises $96 Million

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

Michael Barbella, Managing Editor 06.01.21

Double-Digit Growth Predicted for South Korean Renal Dialysis Market

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

Michael Barbella, Managing Editor 06.01.21

Cardiovascular

Varian's Cardiac Radioablation System Earns Breakthrough Status

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

Sam Brusco, Associate Editor 05.28.21

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

Digital Health

Philips, UCSF Team Up to Enhance Digital Patient Experience

UCSF will use Philips HealthSuite to oversee development of new technologies.

Sam Brusco, Associate Editor 05.27.21

amg International Receives CE Mark for Unity-B Biodegradable Stent

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

Charles Sternberg, Assistant Editor 05.26.21

Lessons from the Lab: Testing Orthopedic Devices

Changes in testing protocols and revised regulatory demands make testing experts even more valuable than they’ve ever been.

Non-Traditional Thinking Can Help Drive Medtech R&D

Non-healthcare-related companies like Google, Amazon, and Apple can provide the medtech industry with unique solutions to age-old problems.

Minnetonka, Minnesota Cardiovascular Testing

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Element Global Medical Device Capabilities

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Diagnostics

Heru Inc. Closes $30 Million Series A Financing

Advances its cloud and AI-enabled wearable vision diagnosis and therapy.

Charles Sternberg, Assistant Editor 05.20.21

Neuronetics Appoints Robert Cascella to its Board of Directors

Former Hologic CEO brings more than three decades of leadership experience within the healthcare sector.

Michael Barbella, Managing 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

Electronics

Miniaturizing Linear Motion and Measurement—A Medical Equipment Challenge

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

Christian Meier, Senior Product Manager, SCHNEEBERGER 05.14.21

Tech Etch Appoints Brian Roberts as CFO

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

Charles Sternberg, Assistant Editor 05.14.21

Contract Manufacturing

Empowering Connected Medtech Manufacturing Workers

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

Louis Columbus, Enterprise Software Strategist, DELMIAWORKS 05.13.21

Contract Manufacturing

A Contract Manufacturer Selection Handbook

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

Ashley Turrell, Director of Strategy, Natech Plastics 05.13.21

Digital Health

Empowering Value-Based Care Through Interoperability

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

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

Chronic Disease

NXgenPort Enters License Agreement with Mayo Clinic

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

Charles Sternberg, Assistant Editor 05.12.21

J&J Vision ACUVUE Abiliti Overnight Lenses for Myopia Earn FDA Approval

First and only FDA-approved orthokeratology contact lens for myopia management, according to company.

Sam Brusco, Associate 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.

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

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

Michael Barbella, Managing Editor 05.11.21

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

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

Michael Barbella, Managing Editor 05.10.21

Paige Appoints Chief Commercial Officer and Medical Director

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

Michael Barbella, Managing Editor 05.10.21

RenovaCare Appoints Interim President and CEO

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

Michael Barbella, Managing Editor 05.10.21

Patient Monitoring

Medtronic Rolls Out SonarMed Pediatric Monitor

Alerts clinicians to potential airway obstructions during ventilation.

Sam Brusco, Associate Editor 05.10.21

Chronic Disease | Diagnostics

GE Healthcare Buys Zionexa, a Breast Cancer Dx Startup

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

Sam Brusco, Associate Editor 05.06.21

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

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

Wytech Industries Appoints President

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

Charles Sternberg, Assistant Editor 05.05.21

Stephanie Fehr Appointed to Invacare Corporation's Board

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

Michael Barbella, Managing Editor 05.05.21

Surgical

FDA Clears XPERIENCE No Rinse Antimicrobial Solution

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

Michael Barbella, Managing Editor 05.04.21

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

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Five Tips to Protect IP While Working with a Freelancer

Freelancers provide various benefits, but you need to be able to know how to ensure you have a degree of trust with them.

Ramya Sriram, Digital Content Manager, Kolabtree 04.29.21

Materials

The Plastics Problem—Infection Control vs. Medical Equipment

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

Ryan Hoobler, VP of Engineering, Code Corporation 04.29.21

Tubing & Extrusion

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

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

Electronics

EMS Providers Play Key Role in Product Development Amid Pandemic

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

Michael Barbella, Managing Editor 04.27.21

Neurological

FDA OKs BrainsWay's Three-Minute Theta Burst Protocol for Depression

Shorter protocol further expands access to care.

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

Cardiovascular Systems Acquires Peripheral Support Catheters from WavePoint Medical

Agreement also includes development of portfolio of CTO products.

Michael Barbella, Managing Editor 04.26.21

Digital Health

What Could Medical Device Hacking’s Future Look Like?

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

Sean Fenske, Editor-in-Chief

Electronics

OEMs Increasingly Choosing EMS Providers Closer to Home

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

Michael Barbella, Managing Editor 04.23.21

Gynesonics Appoints Susan Stimson to Its Board of Directors

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

Michael Barbella, Managing Editor 04.20.21

Electronics

EMS' Engineering Resources Increasingly in Demand

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

Michael Barbella, Managing Editor 04.20.21

Seed Grants Awarded to Five Proposals for Pediatric Medical Device Development

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

Michael Barbella, Managing Editor 04.19.21

Iterative Scopes Announces IBD-Focused Scientific Advisory Board

The governing body also will include experts in artificial intelligence.

Michael Barbella, Managing Editor 04.16.21

Electronics

Fiber Optics Introducing New Cleanliness Requirements for Medical Electronics

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

Michael Barbella, Managing Editor 04.15.21

Diagnostics

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

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

Charles Sternberg, Assistant Editor 04.15.21

Thermo Fisher Scientific to Acquire PPD for $17.4 Billion

The deal establishes Thermo Fisher as a global leader in the high-growth clinical research services industry.

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

Vicarious Surgical Appoints CFO and Chief Legal Officer

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

Michael Barbella, Managing Editor 04.14.21

Nagarro Achieves ISO 13485 Certification

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

Michael Barbella, Managing Editor 04.14.21

MICRO Expands with New Facility in Costa Rica

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

Charles Sternberg, Assistant Editor 04.13.21

Qosina Announces Expanded Portfolio for Bioprocess Single-use Systems

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

Diagnostics

DiaSorin to Buy Luminex for $1.8B

Provides access to proven Luminex multiplexing technology and molecular testing solutions.

Sam Brusco, Associate 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

Contract Manufacturing | R&D & Design

Moving from Concept to Design—MPO Videobites

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

Sean Fenske, Editor-in-Chief

SMC Ltd. Expands Costa Rica Facility

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

Charles Sternberg, Assistant Editor 04.07.21

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

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

Company initiates an early feasibility study in the United States.

Michael Barbella, Managing Editor 04.07.21

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

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

Michael Barbella, Managing Editor 04.05.21

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

Second Sight Aborts Business Combination with Pixium Vision

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

Sam Brusco, Associate Editor 04.05.21

Surgical

Biomechanical Engineer, Heal Thyself

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

Dawn A. Lissy, Founder & President, Empirical 04.01.21

Molding | Surgical

Optimizing MIM in Medical Device Manufacturing

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

Steve Santoro, Executive Vice President, MICRO 04.01.21

Diagnostics

PPE and Diagnostics: Sourcing Domestically and Speeding Time to Market

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

Claudio Hanna and Ralph Tricomi , Web Industries 04.01.21

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

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

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.

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

Neurological

Encora's Tremor Reducing Wristband Gains Breakthrough Status

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

Sam Brusco, Associate Editor 03.31.21

Electronics

Talented Labor Pool a Challenge for EMS Providers

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

Michael Barbella, Managing Editor 03.31.21

Bassetti Acquires 3DTRUST

The deal expands Bassetti’s TEEXMA for additive manufacturing solution suite.

Michael Barbella, Managing Editor 03.31.21

Alaxo Airway Stents Establishes Partnership With Portage College

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

Michael Barbella, Managing Editor 03.31.21

Diagnostics

Diagnosing the IVD Market: An Interview with TEAM Technologies

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

Sam Brusco, Associate Editor 03.30.21

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

Ultrasound Stimulation Can Reduce Obesity, Research Indicates

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

Michael Barbella, Managing Editor 03.29.21

Harnessing Critical Health Data With Wearable Technology

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

Robert Newberry and Matthew Rodencal, Sanmina Corporation 03.26.21

Cardiovascular

FDA Approves Medtronic's Harmony TPV for Congenital Heart Disease

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

Sam Brusco, Associate Editor 03.26.21

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

Philips Partners With DiA Imaging Analysis to Enhance Ultrasounds

New AI technology automates the process of manually capturing and visually analyzing ultrasound images.

Michael Barbella, Managing Editor 03.25.21

Masimo's Rad-G With Temperature Earns CE Mark

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

Michael Barbella, Managing Editor 03.24.21

Tissium Appoints VP of Global Operations

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

Charles Sternberg, Assistant Editor 03.23.21

Software & IT

5 Ways Manufacturers Can Improve IoMT Device Security

Manufacturers cannot make development and security mistakes with IoMT devices.

Emily Newton, Editor-in-Chief, Revolutionized 03.23.21

Surgical

Medtech Matters: Robotic-Driven Percutaneous Procedures

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

Sean Fenske, Editor-in-Chief 03.23.21

Cardiovascular | Surgical

CSI Buys Peripheral Support Catheters from WavePoint Medical

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

Sam Brusco, Associate Editor 03.22.21

Contract Manufacturing | Molding

Medtech Makers: Molding Validation Optimization

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

BGF Invests in Vascular Closure Devices Firm

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

Michael Barbella, Managing Editor 03.19.21

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

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

Michael Barbella, Managing Editor 03.19.21

Detecting COVID-19 With a Skin Sticker

University of Missouri engineer receives grant to plan for large-scale manufacturing of an on-skin, wearable bioelectronic device.

Michael Barbella, Managing Editor 03.17.21

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

An Overview of the ASCA Pilot Program

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

David Jensen, Staff Writer, MasterControl 03.11.21

TransEnterix Establishes European Training Center

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

Michael Barbella, Managing Editor 03.11.21

Ventec Life Systems Appoints New Leader

Former Philips exec Jim Alwan takes the helm of the respiratory therapy firm.

Sam Brusco, Associate Editor 03.10.21

Why Bad Products Still Ship and Good People Have to Clean Up the Mess

If there’s one thing common across manufacturing industries that companies can agree on, they hate recalls.

03.09.21

FDA Approves Second Sight's Argus 2s Retinal Prosthesis

Features significantly more processing power.

Sam Brusco, Associate Editor 03.08.21

NMR Spectroscopy

Nuclear Magnetic Resonance (NMR) spectroscopy is a structural analysis method that is invaluable for the verification of chemical synthesis and compounds.

Deciding whether to insource or outsource your testing

The medical device industry is filled with motivated medical entrepreneurs who have the next most significant concept to better human life.

Evaluating additively manufactured titanium per ASTM F3001

The continuous development of additive manufacturing processes for titanium medical devices opens the door to complex designs w/ improved anatomic geometries

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

NAMSA Acquires American Preclinical Services

Enhances its preclinical solutions with a broader range of laboratory models and analysis tools.

Charles Sternberg, Assistant Editor 03.02.21

Surgical

Olympus to Purchase Israeli Firm Medi-Tate to Grow Urology Biz

Medi-Tate's iTind nitinol implant supports lower urinary tract symptom relief due to benign prostatic hyperplasia.

Sam Brusco, Associate Editor 03.02.21

Axonics Buys Contura to Expand to Stress Urinary Incontinence

Gains Bulkamid, a urethral bulking agent for women.

Sam Brusco, Associate Editor 03.01.21

Digital Health

Artificial Intelligence, Machine Learning Adoption in Healthcare to Grow Considerably

The FDA’s five-part action plan is expected to drive the surge.

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

Contract Manufacturing | R&D & Design

SteriPack Acquires HS Design

Provides flexible and responsive design, development, and contract manufacturing solutions.

Sam Brusco, Associate Editor 02.23.21

Diagnostics

BD Collaborates with Scanwell Health

Aims to create an at-home rapid test for SARS-CoV-2 using a BD antigen test and the Scanwell Health mobile app.

Charles Sternberg, Assistant Editor 02.22.21

Flywheel Secures $15 Million in Series B Funding

The funding will allow the company to deepen its presence in the life sciences and AI markets.

Michael Barbella, Managing Editor 02.19.21

FDA Clears B-Secur's HeartKey EKG/ECG Technology

The product's algorithms can be quickly integrated in semiconductors for devices in the medtech, health monitoring, and wellness sectors.

Michael Barbella, Managing Editor 02.19.21

RDS Completes 3 Million Euros Seed Funding Round

Funding will be used for the first clinical trials of the MultiSense Connected Sensor Patch.

Michael Barbella, Managing Editor 02.18.21

Quidel Opens New Manufacturing Facility to Boost COVID-19 Antigen Test Production

New plant aims to reach a run rate of 600 million QuickVue tests per year by the end of 2021.

Michael Barbella, Managing Editor 02.18.21

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

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

J. Knipper and Company Adds to its Executive Team

Trio is charged with launching the company's third-party logistics (3PL) unit for 2021.

Michael Barbella, Managing Editor 02.16.21

Diagnostics

Suitcase Laboratory to Detect COVID-19 in Development

Mobile laboratory for rapid detection of SARS-CoV-2 for Africa.

Sam Brusco, Associate Editor 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

Brian P. Kemp Unveils Georgia Made Medical Manufacturing Act

Incentivizes the production of medicines and medical devices in Georgia.

Charles Sternberg, Assistant Editor 02.10.21

FDA Clears Rapid Acoustic Pulse Technology for Use in Cellulite

The RAP device induces mechanical disruption in fibrous structures, such as the septae contributing to dimples in cellulite.

Michael Barbella, Managing Editor 02.10.21

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

Avacta Group and Mologic Enter Commercial Partnership

Aims to accelerate to market Avacta’s SARS-CoV-2 antigen test and support testing in low and middle income countries.

Charles Sternberg, Assistant Editor 02.08.21

BMP Medical - Delivering Custom Plastics Manufactured Solutions

Medical Contract Manufacturing, Design, Assembly & Packaging

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

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

Perspectives on Post-Pandemic: For Manufacturers, Flexibility Is Key

MICRO’s Steve Santoro comments on how medtech suppliers need to be nimble and solution-oriented for customers to ensure success.

Steve Santoro, Executive Vice President, MICRO 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

Neurological

Nēsos Earbud Receives Validation for Treatment of Rheumatoid Arthritis

New study shows promising efficacy and safety profile for novel ‘e-mmunotherapy’ approach to disease treatment.

Charles Sternberg, Assistant Editor 02.02.21

Surgical

Medtech Matters: Medtronic's Robotic Surgery Status

MPO's Sean Fenske speaks with Linnea Burman of Medtronic about the Mazor system and what’s ahead for the firm.

Sean Fenske, Editor-in-Chief 02.02.21

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

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

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

Molding

Medtech Makers: Material Science for Micromolding

Patrick Haney of MTD Micro Molding shares his expertise and helps clarify value of understanding the reaction materials experience.

Signia Appoints New President

New executive most recently worked for Essilor of America.

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

Data Show Porex's Medical Device Filtration Materials Protect Against Virus, Bacteria Spread

Company initiates VFE testing for its porous polymer-based materials; results show components protect against certain aerosolized viruses.

Michael Barbella, Managing Editor 01.22.21

Neurological

Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation

Next-generation digital therapeutic is designed for the treatment of Alzheimer’s disease.

Business Wire 01.14.21

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

Materials

Momentive Performance Materials Acquires KCC Corp.’s Silicones Business

Further strengthens its global capabilities in advanced silicones.

PRNewswire 01.11.21

Diagnostics

Olympus and Hitachi Sign Five-Year Contract

Will jointly develop Endoscopic Ultrasound Systems.

Olympus Corporation 01.11.21

MGS Acquires Formteknik

Expands the MGS team to 1,500 employees, with 11 facilities globally.

MGS 01.08.21

Diagnostics

CareDx Partners with IDbyDNA

Will develop AlloID, a transplant patient-specific metagenomic infectious disease test platform.

Globe Newswire 01.08.21

Solvay Partners With PrinterPrezz on 3D Printing for Medical Devices

Companies are collaborating on 3D printing selective laser sintering (SLS) solutions for implants and other medical devices.

Solvay 01.08.21

New Clinical Trial Data Supports BD Libertas Wearable Injector as a Drug Delivery System

The results show the device effectively delivers dose volumes up to 5 mL subcutaneously.

B3C 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

Vesper Medical Announces First Enrollment in the VIVID Trial

Company initiates pivotal clinical study for next-generation deep venous stent.

Vesper Medical 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

Medtech Veteran Joins VivaLNK Board

Experienced healthcare industry professional to advise VivaLNK’s executive team and assist in its growth in digital health.

VivaLNK 01.05.21

New Company Formed to Develop Peripheral Venous Disease Treatments

VeinWay received a grant from the Ideation Incentive Program of the Israel Innovation Authority.

MEDX Xelerator 01.05.21

Diagnostics

Mologic COVID-19 Rapid Antigen Test Receives CE Mark Approval

Preliminary results show 92% sensitivity and 100% specificity, compared with RT-PCR.

Mologic Ltd 01.05.21

Cardiovascular

Edwards Treats First Patient in Restore Clinical Trial

Evaluates minimally invasive device for mitral valve disease.

Edwards Lifesciences Corp. 12.21.20

New Global Headquarters for Freudenberg Medical

The 37,000 sq. ft. Beverly, Mass. location is equipped with ISO Class 8 cleanrooms for medical molding and assembly.

CM&B Inc. 12.17.20

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

PTC to Acquire SaaS PLM Leader Arena Solutions

PTC reaffirms its cash flow targets for fiscal year 2021.

PR Newswire 12.16.20

4D Biomaterials Awarded Funding for 3D Tissue Scaffolds

The company's new polycarbonate-based resins can be formed into materials that have good shape memory, and tuneable mechanical and chemical properties.

4D Biomaterials 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

Diagnostics

FDA Authorizes First OTC Fully At-Home Diagnostic COVID-19 Test

The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test.

U.S. Food and Drug Administration 12.16.20

TSK Laboratory Offering Free Patent Licenses for its Needle Technology

Company's Low Dead Space needle is expected to reduce wasted COVID-19 vaccine.

TSK Laboratory Europe B.V. 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

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

BellaSeno Establishes High-Throughput Additive Manufacturing Facility for Resorbable Implants

Manufacturing at the facility will be based on the no-touch approach to significantly improve the safety and sterility of medical implants.

BellaSeno GmbH 12.09.20

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

Molding

A 'Trial and Error' Approach to Micromolded Parts

The medical industry's stringent requirements makes innovation difficult for injection-molded components.

Michael Barbella, Managing Editor 12.07.20

Machining & Laser Processing

Social Distancing Badge Lights Way to Return to Work

Fleetwood Electronics’ Instant-Trace system uses machining, on-demand injection molding to speed to market.

Rob Young, Sr. Manager—Injection Molding, Protolabs 12.04.20

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

Olympus Corporation to Acquire Veran Medical Technologies

Strengthens its position as a leading global medical device company.

JCN Newswire 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

3D Systems, Veterans Health Administration Collaborate to Improve Patient Care

Additive manufacturing solutions at the point of care aim to foster innovation and enhance patient care.

3D Systems 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

Materials

Setting the Standard: Protective Nanocoatings for Today's Medtech

Ensuring medical products are safe from the outside environment is a significant challenge that nanocoatings can help resolve.

Zsolt Pulai, EVP, Technology & Development, HZO Inc. 12.02.20

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

Materials

Best Practices in Venting of Medical Devices

Learn how to design the best venting solution for your medical device using custom-engineered porous polymers in this webinar for medical device engineers.

12.01.20

Diagnostics

RSNA News: RADLogics’ AI-Powered COVID-19 Medical Imaging Solutions

The company’s latest algorithm enhancements to help radiologists distinguish between coronavirus and other abnormalities.

RADLogics 11.30.20

Molding

Smaller Cavity Features Not Always Sensible for Micromolded Products

Though the need to reduce size is crucial, small cavity characteristics may be challenging to reproduce in volume.

Michael Barbella, Managing Editor 11.24.20

R&D & Design

New Project-Based Rapid Precision Prototyping Program

Your First Step Is the Most Important

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

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

Machine Solutions Acquires Beahm Designs

Expands its catalog of catheter manufacturing equipment and broadens its engineering resources.

Machine Solutions Inc. 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

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

Molding

Miniaturization of Medical Devices Creating Big Assembly Challenges

Extremely tight tolerances leave no room for error.

Michael Barbella, Managing Editor 11.20.20

Cardiovascular

CARMAT Receives Funding to Conduct Artificial Heart Study in France

Two-thirds of the study's total cost will be financed by the French state.

CARMAT 11.19.20

The Big Challenges of Medical Device Miniaturization

Demand for micro-sized products is prompting micromolders to develop new processes and methods that are outside the norm of standard injection molding.

Michael Barbella, Managing Editor 11.17.20

Digital Health

Avail Medsystems Raises $100 Million in Series B Funding

Money will help the company meet demand for procedural telemedicine technology in the operating room.

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

Three New Members Elected to Titan Medical's Board

Board now consists of a majority of independent corporate directors.

Business Wire 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

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

Mentice to Acquire Vascular Simulations

The combined portfolio will enhance Mentice’s endovascular simulation offerings with proven replication solutions.

Mentice AB 11.13.20

Patient Monitoring

Implantable Sensor Could Measure Bodily Functions, Then Safely Biodegrade

Can monitor various forms of nitric oxide and nitrogen dioxide gas in the body.

Penn State 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

Diagnostics

QIAGEN Launches Portable Digital SARS-CoV-2 Antigen Test

Can accurately analyze over 30 samples per hour.

Business Wire 11.12.20

MDIC Welcomes New Vice President of Health Economics and Patient Value

New executive has more than 30 years of experience working directly with patients and from the administrative perspective.

Business Wire 11.11.20

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

Medtech Makers: Collaborating with Full-Service Design and Development Providers

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

Veteran Medical Device Executives Named to Dimension Inx Board

New members served as startup CEOs and Fortune 200 corporate executives.

Dimension Inx 11.05.20

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

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

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

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

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

Advanced Technology for Staking and Swaging Medical Plastics

It reliably assembles heat- and vibration-sensitive components, and works with a wide range of plastic materials.

Priyank Kishor, Global Product Manager—PulseStaking, Branson at Emerson 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

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

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

Company Developing a COVID-19 Severity Risk Test for U.S. Government

The technology, known as host-response diagnostics, rapidly reads the immune system using multiple mRNA biomarkers and a machine learning algorithm.

Inflammatix 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

Cardiovascular | Electronics | Patient Monitoring

Rubbery Bioelectronic Cardiac Patch Can Monitor, Treat Heart Disease

The device can also harvest energy from the heart beating.

University of Houston 11.04.20

OmniVision Introduces the World’s First Medical RGB-IR Image Sensor

The sensor reduces endoscope size, cost, power, and heat by half.

OmniVision Technologies Inc. 11.04.20

My 2020 Holiday Wish List

There are many lessons to be learned from actions taken during the pandemic. Are there positives that can actually be taken from this mess?

Sean Fenske, Editor-in-Chief 11.04.20

Machining & Laser Processing

Heraeus Medical Components Buys Pulse Systems

Firm expands capabilities in interventional access and delivery with the acquisition of laser processing and manufacturing supplier.

Heraeus Medical Components 11.03.20

Qosina Stocks Popular SmartSite™ Swabbable Needle-free Injection Sites

...

Neurological

Salvia BioElectronics' Neurostim System for Chronic Migraine Earns Breakthrough Status

Bioelectronics solution addresses drug-refractory chronic migraine.

PR Newswire 11.03.20

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

Babson Diagnostics Closes $13.7 Million Series A Financing

Money will be used to democratize blood testing.

Business Wire 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

Cardiovascular

Robocath Creates Joint Venture with MircroPort

Enables the commercialization of Robocath’s R-One platform in China.

Robocath 11.02.20

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

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

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

Materials

Ulbrich Launches Braid Wire Accelerator Program

Fast-tracks device development timelines.

Ulbrich 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

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

Chronic Disease

FDA Grants Breakthrough Device Designation to Cala Trio

Aims to treat action tremors in the hands of adults with Parkinson's disease.

Cala Health 10.22.20

BD Makes Executive Leadership Appointments

Names Patrick Kaltenbach as executive vice president and chief technology officer.

BD 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

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

SETi, Seoul Viosys Begin Mass Production of Coronavirus Sterilization Module

Product sterilizes 99.9 percent of coronavirus in three seconds.

Sensor Electronic Technology Inc. 10.22.20

Electronics

Meeting the Need for Bandwidth Speed

Enhanced video and data communication rates are pushing the limits of medical electronics.

Michael Barbella, Managing Editor 10.22.20

Surgical

Level Ex Introduces Virtual Technique Guides

Allow sales representatives to train surgeons located anywhere in the world.

Level Ex

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

Patient Monitoring

Ingestible Capsule May Help Demystify the Gut-Brain Axis

A platform that can monitor and model gut microbiome serotonin activity.

University of Maryland 10.16.20

Digital Health | Software & IT

GE Healthcare Introduces Edison HealthLink

New edge technology is designed to give clinicians rapid access to critical data.

PR Newswire 10.14.20

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

Diagnostics | Surgical

FDA OKs CrossBay Medical's CrossGlide ETS Plus

Performs frictionless, office-based endometrial biopsy procedure gently, effortlessly, and without a tenaculum.

Business Wire 10.14.20

Molding

A Primer on the Benefits of Metal Injection Molding

High volume, high performance, complex surgical instrument parts are achievable at an affordable cost with the fabrication process.

Steve Santoro, EVP, MICRO 10.13.20

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

Teleflex Medical OEM to Expand Georgia Facility

Aims to meet growing demand for its products.

Teleflex Medical OEM 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

WaveFront Dynamics Initiates $3 Million Series A Round

Money will be used to fund the continued development of Dynamic Wavefront Measurement System for vision correction.

Business Wire 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

Cardiovascular

MedTech Innovator Names Rhaeos as 2020 Winner

Rhaeos is developing a wearable for the noninvasive monitoring of ventricular shunt function for hydrocephalus patients.

Business Wire 10.06.20

Qosina Partners with Resolution Medical to Offer a 3D-Printed Sterile Nasal Swab for COVID-19 Testing

...

Digital Health

Medidata Launches Centralized Statistical Monitoring Solution for Clinical Trials

Medidata Detect identifies known and unknown risks, and triggers corrective actions.

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

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

Materials

Beyond the Status Quo: Eight Often-Overlooked Areas of Medical Textile Product Development

Companies have been successful in bringing devices to market that support MIS approaches in part because of biomedical textile materials.

Shanzeh Farooqui, Development Engineering Lead, Cortland Biomedical 10.01.20

Contract Manufacturing

Medtech Makers: Expediting Time to Market

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

Device Success Contingent Upon Flexible Circuit Design

Defining the requirements unique to the medical application is essential before starting the design.

Michael Barbella, Managing Editor 09.30.20

Wearable Device to Detect COVID-19 Progression is in Development

The device will track a variety of markers, including skin temperature, thoracic bioimpedance, and oxygen saturation.

Shimmer Research 09.22.20

Integrity Applications Appoints Vice President of Product

New executive will be responsible for scaling the GlucoTrack product offering and leading the company’s global product development.

Globe Newswire 09.10.20

Contract Manufacturing

Switchback Medical Creates New Division for Device Development

New service allows for customer product development teams to get more clinically relevant and faster testing feedback.

Switchback Medical 09.02.20

Magstim Acquires Electrical Geodesics Product Portfolio

High-density EEG complements Magstim’s transcranial magnetic stimulation technology.

Business Wire 09.02.20

Machine Solutions Acquires Crescent Design

The deal marks Machine Solutions’ fifth acquisition since joining the BW Forsyth Partners family of companies in 2012.

Machine Solutions Inc. 08.28.20

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

R&D & Design | Software & IT

COVID-19 Marks a Need for Virtual Development Tech

Medical device developers can gain benefits from the use of MR/AR, but challenges need to be addressed first.

Dijam Panigrahi, Co-Founder and COO, Grid Raster Inc. 08.10.20

NeuroOne Medical Technologies Appoints Director of Electrode Development

New hire previously led the microfabrication process engineering team at Neuralink Corp., a company founded by Elon Musk.

Business Wire 08.10.20

Surgical

Olympus Buys Arc Medical Design

Underscores Olympus' commitment to expanding its offering in gastrointestinal therapeutic devices.

PR Newswire 08.07.20

Cardiovascular | Neurological

New Design Principle Could Prevent Brain Shunt Catheter Failure

Major challenge in hydrocephalus catheters—clogging—could be overcome by leveraging catheter geometry.

Mindy Blodgett, Institute for Medical Engineering and Science, MIT 07.31.20

Engineering and Manufacturing Partnerships: The Key to Successful Combination Products

Competent manufacturing partners can help combo product creators successfully develop any type of combo product.

Ursula Nollenberger, Product Line Director; Kevin Ehlert, Segment Manager, Trelleborg Healthcare & Medical 07.13.20

ALung Announces Commercial Development of its Next-Generation Artificial Lung

The next-generation Hemolung RAS is based upon intellectual property recently licensed to ALung from the University of Pittsburgh.

Business Wire 07.08.20

Abiomed Expands Product Portfolio with Breethe Purchase

Abiomed invested in its acquisition target in mid-2019.

Business Wire 07.01.20

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

Surgical

Low-Cost, High-Accuracy GPS-Like System for Flexible Medical Robots

Performs as well as current state of the art methods, but is much less expensive.

University of California - San Diego

Diagnostics

Gold Standard Diagnostics Launches Multiplex Real-Time PCR Assay for SARS-CoV-2

PCR is the method of choice to detect acute coronavirus infections.

Business Wire 05.18.20

Integra Announces Positive Clinical Results for Bilayer Wound Matrix

Data shows IBWM reduced operating room time and costs associated with lower extremity wounds.

Globe Newswire 05.18.20

Cardiovascular

Impulse Dynamics Appoints Cardiac Electrophysiologist as Medical Director

New executive has spent nearly two decades treating heart failure patients.

Business Wire 05.18.20

Surgical

FDA Issues Warning Letters to Two Breast Implant Makers

Allergan and Ideal Implant Inc. failed to comply with various regulatory requirements.

U.S. Food and Drug Administration 05.15.20

Diagnostics

Hologic Granted EUA for Second COVID-19 Molecular Test

Significant test manufacturing capacity, large installed base of automated instruments yield testing breakthrough.

Business Wire 05.15.20

Diagnostics

FDA Warns About Possible Accuracy Concerns With Abbott Coronavirus Test

Agency claims ID NOW may return false negative results; Abbott says some studies are investigating the test's role in ways it was not meant to be used.

PR Newswire 05.15.20

Dianosic Gains CE Mark for Intranasal Bleeding Treatment Device

Product is the first asymmetric intranasal balloon that stops bleeding by applying low-force compression.

Dianosic 05.15.20

Invacare Sells Dynamic Controls Business to Allied Motion Technologies

As part of the deal, Invacare has entered into a long-term product supply agreement with Dynamic Controls.

Business Wire 05.15.20

Diagnostics

Thermo Fisher Scientific Launches the Cascadion SM Clinical Analyzer

The analyzer has a built-in 25-Hydroxy Vitamin D assay designed to deliver accurate, traceable measurements of Vitamin D2 and D3 fractions.

Thermo Fisher Scientific 05.15.20

Cardiovascular

FDA Clears Expanded Indication for Reflow Medical's Wingman Catheter

The new clearance gives physicians the ability to cross (CTOs) in peripheral lesions.

Business Wire 05.15.20

7 'Expanse-ive' Medical Devices

A medical designer’s (very) informal review of sci-fi props in "The Expanse."

Nigel Syrotuck, Mechanical Engineer Team Lead, StarFish Medical 05.14.20

Emory, Georgia Tech Create COVID-19 Barrier Protection Devices

Aerosol box is designed to contain droplet spray.

Emory University

FDA Grants EUA to UMass' Simpler Ventilator Design

UMass Amherst physicist, global team advance practical device for COVID-19.

University of Massachusetts Amherst 05.14.20

Pathen Medical Announces Availability of New 26-Gauge Nanocath I.V. Catheter

The catheter features kink and occlusion-resistant material, active safety needle encapsulation, and a hub providing added comfort.

Globe Newswire 05.14.20

XCR Diagnostics Secures Patent for Infectious Disease ID Technology

Innovation accelerates detection of diseases such as COVID-19 even on existing PCR testing equipment.

Business Wire 05.14.20

Aspen Surgical Names New CEO

Executive's past work experience includes stints at J&J, Smith+Nephew, and Allen Medical Systems.

Business Wire 05.14.20

Magnolia Medical Secures FDA Clearance for Expanded Steripath Gen2 Products

Devices become the first and only products indicated to reduce blood culture contamination.

PR Newswire 05.14.20

R&D & Design

Medtech R&D Process Aided by Big Data, AI

Digital health allows researchers and engineers to incorporate data sets of user behaviors into their prototypes during the early phases of R&D.

Michael Barbella, Managing Editor 05.13.20

Cardiovascular | Diagnostics | Software & IT

Eko's ECG-Based Algorithm Gains EUA to Boost Heart Failure Detection

Can assist in identifying patients with abnormal heart function during the COVID-19 pandemic.

Business Wire 05.13.20

Cardiovascular

Smiths Medical Expands Vascular Access Offering with Access Scientific Buy

The company acquires the POWERWAND midline and extended dwell catheters.

Business Wire 05.13.20

Neurological | Patient Monitoring

Wearable Device Could Prevent Unexpected Epilepsy Death

Device monitors key biomarkers and then sends a wireless signal to a caregiver when it detects abnormalities.

Purdue University 05.13.20

Viveve Completes Enrollment in Stress Urinary Incontinence Feasibility Study

Three-arm study compares Viveve's Cryogen-cooled Monopolar Radiofrequency treatment and cryogen-only sham to inert sham treatment.

Viveve Medical 05.13.20

Mauna Kea's Next-Generation Cellvizio Platform Receives FDA Clearance, CE Marking

The new platform includes significant improvements and will enable major innovations, such as integrating easily with robotic systems.

Business Wire 05.13.20

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

FDA OKs Transit Scientific's XO Cross Microcatheter Platform

New non-tapered metal-alloy catheter platform FDA cleared for use in peripheral vasculature.

PR Newswire 05.12.20

Cardiovascular | Digital Health

Element Science Raises $145.6 Million Series C Financing

Money will be used to advance the company's next-generation digital wearable platform.

Business Wire 05.12.20

Autocam Medical, University Manufacture Ventilator Splitter With Individual Pressure Capability

Conceived only a few weeks ago, the device can overcome limitation for sharing ventilators.

Autocam Medical 05.12.20

Digital Health | Software & IT

FDA OKs Aidoc's AI Algorithms to Help Detect Findings Associated with COVID-19

Facilitates timely patient workup to allow for activation of COVID-19 related protocols.

PR Newswire 05.11.20

Packaging & Sterilization

'Bug Zapper' UV-C Light Enables N95 Mask Sterilization, Reuse

Can decontaminate 200 N95 masks every eight minutes.

Lehigh University 05.11.20

NASA Low Outgassing Rated Epoxy Features Enhanced Chemical Resistance

Product: EP42-2LV Black

Diagnostics

Mologic and BioSure Partner on COVID-19 Antibody Self-Test

Design is suitable for an at home self-test, giving results in 10 minutes.

Mologic Ltd. 05.11.20

Diagnostics

Vitagene Launches First Authorized Saliva-Based Home Test for COVID-19

Company raises $7 million of additional funding to provide widespread testing to consumers.

Business Wire 05.11.20

Diagnostics

Quidel Receives Emergency Authorization for Rapid Antigen COVID-19 Test

Sofia 2 SARS Antigen FIA Point-of-Care assay offers positive results in 15 minutes.

Business Wire 05.11.20

Forefront Medical Technology Changzhou, PRC Facility Capabilities Overview

...

University's Paper Device Could Provide Portable Coronavirus Detection

Developing a process to manufacture the device, however, would cost at least several million dollars.

Purdue University 05.08.20

Vystar Resumes Production of FDA-Certified UV Light Air Purifiers

CDC states UV-C light is one of the most promising methods for coronavirus disinfection of face masks.

Globe Newswire 05.08.20

Neurological

Light-Based Deep Brain Stimulation Relieves Parkinson's Symptoms

Fast-acting, light-reactive genetic tools could reveal how deep brain stimulation works.

Duke University 04.28.20

Diagnostics

BIOTECON Launches SARS-CoV-2 Screening and Identification Kits

The assays are based on the WHO reference methods.

PR Newswire 04.28.20

Former GE Healthcare Executive Assumes Regulatory Role at IRADIMED

New hire also worked for Merz North America.

Globe Newswire 04.28.20

Masimo and MS Westfalia GmbH Expand Partnership

Companies to add Masimo SedLine Brain Function Monitoring, O3 Regional Oximetry to the MSW modular point-of-care hybrid Jenny.

Business Wire 04.28.20

Medtech’s Battle on Multiple Fronts Against COVID-19

From PPE to testing to ventilator solutions, medtech firms are trying to find answers for healthcare’s needs against the novel coronavirus.

Heidi West, Medical Writer, Vohra Wound Physicians 04.27.20

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

Diagnostics

BGI Expands EUA Label for SARS-CoV-2 RT-PCR Test

Adds automated extraction methods and additional PCR systems.

PR Newswire 04.27.20

Hasbro, Cartamundi Partner to Produce Personal Protective Equipment

Companies to donate 50,000 face shields per week to local hospitals in Massachusetts and Rhode Island.

Business Wire 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

Diagnostics

bioMérieux Revenue Will Continue to Grow, Says GlobalData

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

GlobalData 04.20.20

Diagnostics

Blood Test May Help Doctors Catch Pancreatic Cancer Early

Penn study shows liquid biopsy may be viable option for both diagnosis and disease staging.

Penn Medicine 04.16.20

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

Diagnostics

BD Gains Second EUA for CE-Marked Molecular Diagnostic Test

New test uses BD Max System to augment supply from existing collaborations; test results in under three hours.

BD 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

Diagnostics

FDA OKs Luminex's NxTAG CoV Extended Panel to Detect SARS-CoV-2

BARDA award for $642K helped Luminex accelerate development and validation.

PR 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

Diagnostics

Packaging & Sterilization

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