JD Supra

FDA Issues Proposed Rule Classifying Certain Wound Dressings and Liquid Wound Washes For the First Time

After enactment of the Medical Device Amendments of 1976, which established three regulatory classes for medical devices, the Food and Drug Administration (FDA) has been required to classify all ...
JD Supra

FDA proposal classifying wound dressings/washes with antimicrobials may require PMAs, new 510(k)s

Last week, the U.S. Food and Drug Administration (FDA) proposed two new rules for classification of certain, previously unclassified wound dressings and liquid wound washes containing antimicrobials, ...
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 trackers.
Hosted on MSN

FDA scraps ‘Final Rule’ classifying LDTs as medical devices

The US Food and Drug Administration (FDA) has chosen to axe its ‘Final Rule’ from May 2024, bringing to an end a long-running agency-industry dispute around the proposed classification of ...
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 ...
Seeking Alpha

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 ...
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 ...