ConsumerAffairs

FDA relaxes rules for wearable health devices

The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.
Fierce Healthcare

FDA paves way for more consumer wearables, AI-enabled devices to hit the market

The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...
GovInfoSecurity

FDA Takes Hands-Off Approach to AI Devices and Software

New artificial intelligence-enabled health wearable devices and clinical decision support software will not face U.S. Food ...
STAT

Fixing the reimbursement and coverage divide between ‘breakthrough’ drugs and medical devices

The Food and Drug Administration designates as “breakthrough” technologies certain drugs and devices. This designation helps expedite the development and review of therapies intended to treat serious ...
MD&M East

To Be or Not to Be (a Medical Device): FDA Vs. WHOOP

On July 14, 2025, FDA issued a warning letter to WHOOP, Inc., notifying the company that its marketing of Blood Pressure Insights (BPI) was neither cleared nor approved. FDA stated that BPI qualifies ...
Forbes

User-Centered Research Methods For Medical Device Design

In the medical device industry, usability plays a critical role in ensuring the safety and effectiveness of highly complex medical products. The IEC 62366-1:2015 standard, which focuses on the ...
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, ...