For companies developing digital health products, wearables, or software-enabled devices, FDA’s latest guidance updates ...
Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will ...
FDA approves first brain stimulation device for home depression treatment. Flow Neuroscience's FL-100 headset uses electrical ...
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.
The FDA has approved the first prescription, at-home neuromodulation therapy for individuals with major depressive disorder ...
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 ...
The FDA approved external trigeminal nerve stimulation (TNS) in 2019 as the first non-drug device for treating ADHD, ...
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Study questions benefit of FDA-cleared device for ADHD
The agency is currently reviewing the study findings ...
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 ...
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 ...
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