Anita Silver Shlesinger on Muck Rack

Anita Silver Shlesinger

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Articles

Unaddressed implications of the FDA’s 2026 guidance on wellness devices

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By Stephanie Sullivan, Karnika Singh, Perisa Ashar, Jessilyn Dunn, Anita Silver Shlesinger
| Nature Verified
Consumer wearables can measure physiological parameters indicative of health, blurring the boundary between wellness products and medical tools. We critically evaluate the FDA’s 2026 guidance on consumer wearables and sensor-based technologies with regard to validation standards, safety risks, definitional coherence and effects on healthcare integration.
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