Medical Product Outsourcing

P2i Launches Protection Coating for Hearing Aids

The coating will help manufacturers comply with new PFOA regulations.

P2i 10.20.20

Keystone Heart's TriGUARD 3 Cerebral Embolic Protection Device Makes its Clinical Debut

The TriGUARD 3 is the only CE Mark product designed to cover and protect all three major cerebral aortic arch vessels.

PR Newswire 09.22.20

Researchers Redesign the Face Mask to Improve Comfort and Protection

Combines a barrier filtration material with a stretchable fabric to hold it in place.

John Toon, Georgia Institute of Technology 09.04.20

Diagnostics

Device Provides Added Protection Against COVID-19 During Endoscopic Procedures

Device comprises a mouthpiece equipped with a fixing belt and a nonwoven fabric to cover the patient's face, thereby capturing aerosol droplets.

Tohoku University 07.23.20

Patent Marking: The Proper Method to Display Protection

Manufacturers should have an active patent marking program that aids in deterring infringement while minimizing potential liability for false marking.

Douglas Portnow, Principal, Schwegman Lundberg & Woessner, P.A. 07.21.20

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.

Online Exclusives Sam Brusco, Associate Editor 06.09.20

Emory, Georgia Tech Create COVID-19 Barrier Protection Devices

Aerosol box is designed to contain droplet spray.

Videos Emory University

Advancing Infection Prevention Tools

The applications and benefits of porous polymer materials and components.

Jack Chan, Global Marketing Director, Porex

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.

Online Exclusives Heidi West, Medical Writer, Vohra Wound Physicians 04.27.20

Surgical

FDA Update on Essure Postmarket Activities

All unused Essure devices of which Bayer is aware have been returned to the company.

U.S. Food and Drug Administration 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

Trump Signs Bill Replenishing Coronavirus Relief Funding

Legislation provides $484 billion for company payrolls, hospitals, small business loans, and a national testing system.

Staff and Wire reports 04.24.20

Diagnostics

FDA Clears Siemens Healthineers' Aidan AI

The latest technology enables new features and enhanced security.

Siemens Healthineers 04.22.20

Sign Company Repurposes to Make Intubation Boxes for Hospitals

The boxes are designed to be assembled and disassembled in under 60 seconds with minimal effort.

PR Newswire 04.22.20

Molding

Mack Molding, Health System Partner to Develop Face Mask Alternative

Within two weeks, the team fabricated an attachment to a snorkeling scuba mask.

Mack Molding 04.22.20

Surgical | Testing

Medical Robots: Assessing Safety and Performance in a Growing Field

Be aware of potential hazards robots may present and testing options to address them.

Online Exclusives Bill Stearns, Associate Senior Engineer, Intertek 04.17.20

3M, Cummins Partner to Boost Powered Air Purifying Respirator Filter Production

The 3M designed filters will be made in Cummins’ Neillsville, Wis. plant.

Business Wire 04.15.20

Domestic Manufacturing of Medical Devices Trending Due to COVID-19

Ramping up domestic production capacity of medical supplies is the major focus for many countries as the pandemic spreads, according to GlobalData.

GlobalData 04.14.20

Packaging & Sterilization

FDA OKs STERIS Systems to Decontaminate N95 Respirators

Will support decontamination of approximately 750,000 N95 respirators per day in the U.S.

U.S. Food and Drug Administration 04.13.20

Georgia Man Arrested in Multi-Million Dollar COVID-19 Scam

Suspect tried secure orders from the Department of Veterans Affairs for 125 million face masks and other PPE totaling more than $750 million.

U.S. Department of Justice 04.13.20

3D/Additive Manufacturing

UCLA Bioengineers Create Reusable COVID-19 Face Shields

Device’s headband can be mass-produced using 3D injection molding; clear plastic shield is made by laser cutting.

Brianna Aldrich and Christine Wei-li Lee, UCLA Newsroom 04.08.20

Pentax Medical to Pay $43 Million Over Misbranded Endoscopes

Company shipped medical devices without approved instructions for use and failed to file FDA-required adverse event reports of serious infections.

U.S. Department of Justice 04.08.20

PhysIQ Expands Patent Portfolio for Artificial Intelligence Analytics in Wearables

Company receives patent for deep net approach to estimating functional capacity daily from continuous wearable sensor data.

PhysIQ 04.07.20

MIT Begins Mass Manufacture of Disposable Face Shields

A team from MIT has designed disposable face shields that can be mass-produced.

Videos Mary Beth Gallagher, Department of Mechanical Engineering, Massachusetts Institute of Technology

Adopted Proposal Would Delay MDR One Year

The proposal would need the full support of the European Parliament and the Council through an accelerated co-decision procedure.

European Commission 04.03.20

Polyzen Helps to Address Shortage of PPE

Commits to assist manufacturers, hospitals, and other healthcare facilities in getting the supplies they need.

Polyzen 04.03.20

Digital Health

Digital Defenders: COVID-19 Creates a Spotlight on Digital Health Tools

Digital health tools like telemedicine, AI algorithms, and connectivity are playing an increasingly important role in helping prevent and manage disease.

Michael Barbella, Managing Editor 04.01.20

R&D & Design

Top 10 Considerations for Medtech Inventors

If you or your employer is interested in protecting an invention, then filing a patent application may be the way to go.

Ryan Connell and Doug Portnow, Schwegman Lundberg & Woessner 04.01.20

Connecticut Firm Develops an Infection-Control Face Mask Shield

The product provides total face protection for workers in hospitals, healthcare facilities, and other establishments that interact with the public.

PR Newswire 03.31.20

Georgia Permits Shuttered Sterilization Facility to Reopen to Help Fight Pandemic

State temporarily allows Sterigenics to sterilize personal protective equipment and increases BD's device sterilization caseload.

Staff and Wire Reports 03.31.20

Advanced Sterilization Products Extends the Lifespan of N95 Masks

ASP qualified a protocol for reprocessing select N95 masks so hospitals can triple the lifespan of the mask using the Sterrad Sterilizers.

Advanced Sterilization Products 03.30.20

Trump Signs $2 Trillion Coronavirus Stimulus Package

Legislation requires the strategic national stockpile to include certain medical devices necessary for diagnosing and treating COVID-19.

Staff and Wire reports 03.27.20

Digital Health

9 Ways AI Will Disrupt Healthcare in the Next 5 Years

The technology could impact areas from stroke detection to mental health to access to specialized care.

Online Exclusives Scott Molina, IT Consultant 03.26.20

Industry Welcomes Government Direction on Allocation of Ventilators

Advanced Medical Technology Association president/CEO sends letter to FEMA Administrator regarding distribution of devices.

AdvaMed 03.25.20

Cardiovascular | Patient Monitoring

FDA OKs AliveCor's KardiaMobile 6L to Measure QTc in COVID-19 Patients

Monitors QT duration in patients receiving medications that can cause potentially life-threatening QT prolongation.

PR Newswire 03.24.20

Former Visiogen Chief Executive Tapped to Lead PROCEPT BioRobotics

New CEO also held the top position at Avedro, which was acquired by Glaukos in November 2019.

Business Wire 03.19.20

Paragonix Reports First Successful Use of its SherpaPak Cardiac Transport System

Product is the only FDA-cleared and CE-marked device that safeguards hearts between donor and recipient patients.

Business Wire 03.17.20

Emboline Completes $5 Million Bridge Round of Financing

Funding will help the company prepare for a U.S. trial of the Emboliner Protection Catheter and commercialization efforts in Europe.

Business Wire 03.11.20

FDA Suspends Foreign Inspections

The agency has postponed most foreign inspections through April, effective immediately.

Food and Drug Administration 03.10.20

Cardiovascular

TriGUARD 3 Cerebral Embolic Protection Device Wins CE Mark

Reduces risk of cerebral damage by deflecting debris from cerebral circulation during transcatheter heart procedures.

PR Newswire 03.10.20

R&D & Design

Four Considerations for Developers of Next-Generation Combination Products

Bringing together real-time monitoring, telemedicine, AI, interventions, and pharmaceuticals into a single device produces a number of potential pitfalls.

Mark Goodman and Barry Thompson, Baker & McKenzie LLP 03.04.20

Materials

A Matter of Substance: Medical Device Materials

Medtech manufacturers are leveraging cleaner, more lightweight materials to meet increasing demand for home healthcare solutions and wearable devices.

Michael Barbella, Managing Editor 03.04.20

Cardiovascular

Getting to the Heart of the Matter: An Examination of Transcatheter Heart Technologies

Transcatheter structural heart therapies stand to replace their open-heart counterparts thanks to technological innovations and expanded patient access.

Sam Brusco, Associate Editor 03.04.20

Testing