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 ...
Gene therapy milestone: FDA accepted Ultragenyx’s resubmission for UX111, targeting Sanfilippo syndrome type A, with a decision expected by September 19, 2026. Tremor device cleared: Cala kIQ Plus, a ...
The FDA’s January 2026 update to its “General Wellness: Policy for Low Risk Devices” guidance materially expands the types of wearable features that may avoid medical device regulation. Signaling a ...
FDA updated its General Wellness policy to clarify and take a step back from previous positions on health and wellness technology. The Food and Drug Administration (“FDA”) unexpectedly updated its ...
The Food and Drug Administration on Tuesday released two final guidance documents that would loosen regulations for certain types of wellness and software products. FDA Commissioner Marty Makary ...
FDA-approved Nerivio REN wearable device is a noninvasive, drug-free way to treat migraine headaches
A device that is a noninvasive, drug-free way to treat and prevent migraine headaches is now FDA-approved for use in children. Millions of people suffer from migraine headaches that can be ...
Please provide your email address to receive an email when new articles are posted on . The SONU Band was initially approved for adults aged 22 years and older with moderate to severe nasal congestion ...
The FDA will not regulate wearable devices that provide nonmedical-grade health information, a move aimed at giving technology companies clearer guidance as AI-driven health tools proliferate, Fox ...
Sonu uses acoustic vibrational energy to relieve congestion in 15 minutes or less. Sonu, an AI-enabled wearable device, is now approved for use in pediatric patients aged 12 years and older for the ...
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