FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less ...

The FDA announced wearable devices providing non-medical information won't face regulation, offering clarity on digital ...

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 ...

New artificial intelligence-enabled health wearable devices and clinical decision support software will not face U.S. Food ...

The agency announced Tuesday that it is reducing oversight of digital health products. Commissioner Marty Makary unveiled the news in a speech at the Consumer Electronics Show. Also: Utah is allowing ...

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

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

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

FDA nonmedical wearable health data devices providing general health info will not face regulation, clarifying guidance for ...

FDA’s decision to limit regulations of non-medical grade wearables marks a notable shift toward regulatory restraint in digital health. FDA announced its plan to stop subjecting non-medical grade ...

Swedish neurotech startup Flow Neuroscience has secured FDA approval for the first brain stimulation device for home use in ...