JD Supra

FDA’s 2026 CDS and General Wellness Guidance Updates

For companies developing digital health products, wearables, or software-enabled devices, FDA’s latest guidance updates ...
MedTech Dive

FDA guidance eases wearables oversight. But experts have questions about what’s next.

Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will ...

FDA clears first at-home brain device for depression

FDA approves first brain stimulation device for home depression treatment. Flow Neuroscience's FL-100 headset uses electrical ...

As Healthcare AI Changes On The Fly, FDA Reconsiders How To Keep It Safe

The FDA's approval process was designed for medical devices that stay largely the same after launch. Clinical AI does not operate this way; it is built to evolve.
Healio

FDA approves neuromodulation device for adults with major depressive disorder

The FDA has approved the first prescription, at-home neuromodulation therapy for individuals with major depressive disorder ...
JD Supra

Digital Health Policy: FDA Relaxes Restrictions over Wearables and AI Decision Making Tools in Two New 2026 Guidances

On January 6, 2026, the U.S. Food & Drug Administration (FDA) updated two guidance documents, General Wellness: Policy for Low Risk Devices ...
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. Officials say the move is intended to speed innovation while maintaining ...

FDA-Approved Nerve Stimulation Device For ADHD Is Ineffective, Clinical Trial Concludes

The FDA approved external trigeminal nerve stimulation (TNS) in 2019 as the first non-drug device for treating ADHD, ...
MedPage Today on MSN

Study questions benefit of FDA-cleared device for ADHD

The agency is currently reviewing the study findings ...
NBC 7 San Diego

FDA moves to rehire medical device staffers fired only days earlier

Barely a week after mass firings at the Food and Drug Administration, some probationary staffers received unexpected news over the weekend: The government wants them back. Beginning Friday night, FDA ...
HealthLeaders Media

FDA relaxes rules for wearable health devices

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 ...