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The FDA's 19-page general wellness policy lets smart ring companies skip clinical validation entirely. Every wearable you have heard of lives inside that loophole. The difference between wellness and medical is not a matter of degree. It is a matter of whether anyone tested the accuracy before it shipped.
Consumer wearables run reflective PPG on body parts never designed for it. The FDA has scrutinized these monitors since 2022 for systematic bias. Smart rings compound the problem with clamp pressure and unvalidated algorithms.
