In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...
FDA announces wearable devices providing non-medical info won't face regulation, offering clarity on digital health ...
The FDA classification underscores the urgency of the situation and the potential danger posed by the contaminated products.
The Naox Link system uses soft, biocompatible in-ear electrodes integrated into wired earbuds to acquire, record, and ...
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 ...
“FDA’s proposed rule, ‘Use of Formaldehyde and Formaldehyde-Releasing Chemicals as an Ingredient in Hair Smoothing Products ...
FDA nonmedical wearable health data devices providing general health info will not face regulation, clarifying guidance for ...
The Beltway-based biopharma disputed the FDA’s conclusions regarding the data provided in its supplemental application for ...
The FDA has granted breakthrough therapy designation to privosegtor for optic neuritis, a common symptom of multiple ...
The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.
Company Transitions from Infrastructure Buildout to Active Market Execution as Expanded 510(k) Review Enters Final ...
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