The FDA has introduced new guidance regulating wearable devices and AI-enabled software that promote healthy lifestyles, distinguishing between non-medical wellness tools and medical technologies. Fitness apps and activity trackers, if unassociated with disease claims, remain exempt from strict FDA oversight. Commissioner Marty Makary emphasized the need to balance innovation with consumer protection, stating that AI tools should complement clinical care rather than replace it. Following the announcement, shares for companies like Abbott, Medtronic, and Garmin rose, indicating positive market reactions. The FDA seeks to clarify regulations, allowing companies to provide informational tools without extensive regulation, unless they claim to be medical-grade, like blood pressure monitors. Makary highlighted the importance of accurate product classification, referencing recent enforcement against WHOOP for misrepresenting wellness insights as medical diagnostics. The FDA urges consumers to remain vigilant about unauthorized devices, reinforcing the distinction between wellness and regulated medical products. Stay updated on Digital Health News for further developments.
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