This week in Pedersen's POV, our senior editor argues against FDA's huge shift in digital health — made without public ...
GlobalData on MSN
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 ...
FDA plans limited regulation of wearable medical devices, boosting Apple, Fitbit, Oura stocks as 50% of Americans use fitness ...
In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...
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 ...
The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.
The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...
The FDA will ease regulation of digital health products, aiming to deregulate AI and promote its widespread use.
The FDA announced wearable devices providing non-medical information won't face regulation, offering clarity on digital ...
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