GlobalData on MSN

FDA announces regulatory exemptions for ‘non-medical grade’ devices

FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less ...
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 to hit the market, eases regulation of AI-enabled devices

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

Wearable health devices could generate a million tons of e-waste by 2050

This week in Las Vegas, tech companies at CES 2026 are unveiling the latest wearable health devices — glucose monitors, blood ...
The American Bazaar

FDA moves to ease oversight of wearable health and wellness devices

Wearable health devices may soon operate under looser regulatory oversight following new guidance from the FDA ...
STAT

FDA announces sweeping changes to oversight of wearables, AI-enabled devices

The FDA will ease regulation of digital health products, aiming to deregulate AI and promote its widespread use.
GlobalData on MSN

Differing device regulation between regions causes trial challenges

Medical Devices includes a session from a regulatory expert on how companies can align their research between regions.

US FDA to limit regulation of health and fitness wearables, commissioner says

The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed ...

Here’s how Samsung plans to track brain health using your devices

Samsung plans to showcase a Brain Health feature at CES 2026 that uses wearable and smartphone data to flag early dementia ...
Medical Device and Diagnostic Industry (MD+DI)

Skincubator Scores FDA Breakthrough Device Designation

The Skincubator is a wearable designed to enable immediate, prolonged skin-to-skin care for the tiniest preterm infants in ...

NAMSA Announces Strategic Acquisition of Select Assets of the Early Development Medical Device Testing Business of Labcorp

NAMSA, a global leader in medical device testing, clinical research, and regulatory consulting, is pleased to announce it has ...

Classifying air purifiers as medical device will restrict market entry, Centre tells HC

However, the Centre has rejected this argument, stating that medical devices attract a lower GST rate owing to a rate ...