Medical Device and Diagnostic Industry (MD+DI)

FDA’s New Rules for Wearables

FDA plans limited regulation of wearable medical devices, boosting Apple, Fitbit, Oura stocks as 50% of Americans use fitness ...
CounterPunch

The FDA Fails to Protect Americans from the Medical Device Industry

Americans cannot rely on the Food & Drug Administration (FDA) to guarantee that medical devices are safe, and a recent Government Accountability ...
Medical Device and Diagnostic Industry (MD+DI)Opinion

FDA's Deregulation of Wellness Devices Is a Slippery Slope

This week in Pedersen's POV, our senior editor argues against FDA's huge shift in digital health — made without public ...
MobiHealthNews

Understanding FDA's new MDDS rule

To many people, including especially those who are not familiar with FDA's medical device regulations, reading the new MDDS rule is a bit difficult. We all like to read stories that have a beginning, ...
FierceBiotech

GAO probe finds understaffed FDA putting some medical device recall work on the 'back burner'

The FDA’s oversight of medical device recalls continues to be plagued by staffing challenges—forcing some activities to be placed on the “back burner” and resulting in lengthy response times, ...
Hosted on MSN

US FDA medical device clearance demystified – what investors need to know

FDA classifies medical devices based on the type of device and the level of risk it poses Three main FDA clearances for medical devices are 510(k), de novo and pre-market approval Several ASX ...
Crain's Chicago Business

Durbin, Schakowsky take aim at medical device recalls

Illinois Sen. Dick Durbin and Rep. Jan Schakowsky want an electronic format for medical device makers to quickly and transparently report recall information to federal regulators to improve what they ...
WTNH

Spectral AI’s DeepView SnapShot® Wound Imaging System, Achieves UKCA Mark and FDA Class 1 Medical Device Classification

DALLAS, Oct. 19, 2023 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI; MDAIW) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster ...