We sat down with @willahmed (Founder & CEO @WHOOP) to discuss wellness tech regulation. "The role of the FDA is to regulate products that have a medical diagnosis. "The 21st Century Cures Act makes it clear that if a product is intended for wellness, it's not designed to be regulated." "For example, you can say hours of sleep staging is wellness. An apnea diagnosis is medical." "We brought blood pressure insights to market; FDA says it should be regulated." "We built this wellness feature and now we're in a debate with the FDA over it. But we're fighting to keep this product in the market because at the end of the day, it's the right thing to do."
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