Instead of making life easier for medical device companies, the FDA’s new wearables guidance makes the market more complex.
On February 2, 2026, the U.S. Food and Drug Administration (FDA) published its anticipated compliance program manual, ...
On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice ...
Smart ring market leader Oura is trying to convince U.S. lawmakers to loosen some health monitoring regulations for wearable ...
Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will ...
The FDA has announced that it will relax portions of its regulatory framework governing wearable health devices, a move the agency says is designed to encourage innovation and expand consumer access ...
FDA plans to limit the regulation of wearable medical devices, according to a January 6 notice from the agency. Currently, the majority of fitness tracking wearables and fitness apps are classified as ...
Fulfilling the required changes to FDA’s quality management system regulation (QMSR) ahead of February 2026’s compliance deadline is much ado about nothing for most companies, according to Kim ...
In a regulatory milestone, the FDA clears AuraWell’s PEMF technology as the first over-the-counter frequency therapy device ...
Medical Device Network on MSN
Sonorous receives FDA breakthrough designation for BosSTENT device
BosSTENT is a braided stent with enhanced radiopacity, resheathability, and conformability for complex neurovascular anatomy.
The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices. Officials say the move is intended to speed innovation while maintaining ...
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