Regulatory & Quality

Medtech in a Minute: Boston Scientific's Big M&A, Medtronic's HeartWare Problem, and More

Mar 05, 2021

Pressed for time? Here's the medtech news you need most, in one minute or less.

FDA Warns Companies for Improper Use of Thermal Imaging Systems

Mar 05, 2021

The federal agency issued warning letters to Certify Global Inc., Kogniz Inc., Opgal Optronic Industries Ltd., and Thermavis.

Understanding ASTM’s New Specification for Barrier Face Coverings

Mar 04, 2021

ASTM has published F3502-21, a standard specification for general-purpose face coverings, which could help consumers understand covering filtration efficiency and more.

HeartWare Causes More Heartache for Medtronic

Mar 03, 2021

Medtronic is recalling the pump implant kit for its HeartWare Ventricular Assist Device two deaths and many serious injuries were reported. This is the company's second HeartWare-related recall in about a year, and one of several in the device's...

Celebrate Sterile Packaging Day and All that Sterile Packaging Affords

Mar 02, 2021

Members of the Sterilization Packaging Manufacturers Council share how patient safety prompted the idea for Sterile Packaging Day—as well as the council’s overall mission.

FDA Authorizes First Surgical Robot to Help with Transvaginal Hysterectomies

Mar 01, 2021

Hominis is also the first robot-assisted surgical device with arms designed to replicate the motions and capabilities of a surgeon's arms, with shoulder, elbow, and wrist joints, allowing the robot to access and reach through areas not possible...

What the Minerva Supreme Court Decision Could Mean for the Medical Device World and Beyond

Feb 25, 2021

Will the “assignee estoppel” doctrine survive future court decisions, or will other patent protections need to be adopted?

Medtronic Recalls Valiant Navion Due to Patient Safety Issue

Feb 25, 2021

Medtronic said three clinical trial patients were observed to have stent fractures. Two of the patients have endoleaks and one patient has died.

FDA Pivots on COVID-19 Guidance for Product Developers

Feb 23, 2021

FDA issued a new suite of guidances for developers of COVID-19 tests, vaccines, and therapeutics to address variants of the virus.

Medtech in a Minute: FDA's Flawed Testing Guidance, Liquid Biopsy, and More

Feb 22, 2021

Pressed for time? Here's the medtech news you need most, in one minute or less.

Keep You Informed