“Medical grade” is a phrase, not a certification. It’s not defined by any regulatory agency. It’s not verified by any lab. And companies don’t need anyone’s permission to print it on a box.
There are really two ways companies arrive at that decision. They can submit their product for FDA review before they ever sell anything, which means betting on a product nobody has bought yet. Or they can build a consumer following first, let real usage prove there’s a market, and only then bring their product, and related evidence, to the FDA to earn clearance. Both are legitimate strategies, and sometimes the path is predetermined for you.
Eight Sleep spent years selling a temperature-regulating mattress cover with the integrated sleep sensor technology as a wellness product, slowly amassing what’s now one of the largest sleep datasets in the world. Only after that, with customers and data already in hand, did the company file FDA applications for medical-device classifications covering sleep apnea and, separately, menopause. The goal is a device that can screen, detect, and intervene at a population scale, not just flag a risk. CEO Matteo Franceschetti says customers are effectively “sleeping on a stethoscope,” and the connected artificial intelligence system is already flagging cardiovascular patterns internally that it can’t yet disclose because the FDA hasn’t reviewed the evidence. The product came first. The proof is catching up to it.
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