Skip to main content
New Year’s Sale — Build a balanced news diet with 40% off Vantage
Get Started
SubscribeLogin
Published • loading... • Updated

FDA exempts more wearable, AI features from oversight

The FDA's new guidance exempts some wellness wearables and AI clinical tools from regulation to promote innovation, clarifying boundaries between wellness and medical diagnosis.

Summary by healthcaredive.com
The regulator clarified the types of wellness features and clinical decision support tools that don’t fall under medical device oversight in a pair of new guidance documents.

3 Articles

healthcaredive.comhealthcaredive.com
Reposted by
medtechdive.commedtechdive.com
Center

FDA exempts more wearable, AI features from oversight

The regulator clarified the types of wellness features and clinical decision support tools that don’t fall under medical device oversight in a pair of new guidance documents.

Read Full Article
Zero HedgeZero Hedge
Right

FDA Says Many Fitness Wearables, AI Tools Exempt From Regulation

ZeroHedge - On a long enough timeline, the survival rate for everyone drops to zero

·United States
Read Full Article
Think freely.Subscribe and get full access to Ground NewsSubscriptions start at $9.99/yearSubscribe

Bias Distribution

  • 67% of the sources are Center
67% Center

Factuality Info Icon

To view factuality data please Upgrade to Premium

Ownership

Info Icon

To view ownership data please Upgrade to Vantage

healthcaredive.com broke the news in on Thursday, January 8, 2026.
Too Big Arrow Icon
Sources are mostly out of (0)

Similar News Topics

Artificial Intelligence icon

Artificial Intelligence

United States icon

United States

News
Feed Dots Icon
For You
Search Icon
SearchBlindspot LogoBlindspotLocal