FDA plans limited regulation of wearable medical devices, boosting Apple, Fitbit, Oura stocks as 50% of Americans use fitness ...
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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 ...
In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...
The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed ...
FDA nonmedical wearable health data devices providing general health info will not face regulation, clarifying guidance for ...
FDA announces wearable devices providing non-medical info won't face regulation, offering clarity on digital health ...
The FDA will ease regulation of digital health products, aiming to deregulate AI and promote its widespread use.
The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...
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 ...
Questions about cost and patient benefit loom as Congress considers automatic Medicare coverage for 'breakthrough' medical ...
Swedish neurotech startup Flow Neuroscience has secured FDA approval for the first brain stimulation device for home use in ...
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