Regulatory & Quality

An Ingredient List for Your Medical Device?

Jun 16, 2021

FDA seeks feedback on medical device content labeling.

Philips Issues Recall for Some of its Ventilators and Sleep Apnea Devices

Jun 14, 2021

The impetus behind the recall stems from the fact the foam used to dampen the machines’ sound can degrade and emit small particles that irritate airways.

Don't Use This COVID-19 Rapid Test, FDA Warns

Jun 14, 2021

FDA wants the public to stop using the Innova SARS-CoV-2 antigen rapid qualitative test for diagnostic use. The agency raised concerns about the performance of the test, which has not been authorized, cleared, or approved for the U.S. market. The...

The New and Improved ISO 10993-12:2021—What Is Really Changing

Jun 02, 2021

While the updated standard features no major revisions, there is more discussion on what to consider for sample preparation.

FDA Hopes to Curb Infection Risks with New Endoscope Clearances.

May 31, 2021

The federal agency gave out nods to EndoFresh and UroViu for endoscopes.

Medtech in a Minute: AliveCor's Spat with Apple, Boston Scientific's Stent Problem, and More

May 28, 2021

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

Boston Scientific Recalls Over 30,000 Stent Systems Due to Migration Risk

May 24, 2021

FDA said there have been 17 complaints and reported injuries related to this issue, but no reported deaths.

Abbott’s CE Mark for Navitor is a New Chapter for TAVR

May 17, 2021

Abbott said the Navitor device is implanted with Abbott's FlexNav delivery system, which received CE Mark in 2020.

Your Phone or Smart Watch May be Messing up Your Pacemaker

May 14, 2021

FDA says to keep cell phones and smart watches at least six inches away from implanted medical devices, such as pacemakers and defibrillators.

How Will UK’s MMD and EU’s MDR Affect the Medtech Industry?

May 12, 2021

The landscape of the medical device industry is changing.

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