You’re basically saying "92% accurate" devices will cause harm, so let’s ban them outright. Even if the failure was death, we should allow it. It's a free count

You’re basically saying "92% accurate" devices will cause harm, so let’s ban them outright. Even if the failure was death, we should allow it. It's a free country. We let consenting adults do all sorts of dangerous stuff — base jumps, do weird diets, drink alcohol, smoke, etc — yet somehow medical device regulation treats personal risk tolerance as if it’s off-limits. But the failure scenario is not death. It's an unnecessary hospital visit. And you STILL want it banned. If someone wants early heart-attack warnings at 92% accuracy, that should be their call. As for costs, a few thousand false alarms might clog ERs and bill wallets, but big deal. That’s the price of getting these things in the wild and learning what actually works. More wearables in real world situations equals massive real-world data, faster device improvement, economies of scale, and ultimately, over the long run, millions of prevented heart attacks — plus orders-of-magnitude lower costs down the road. I’d take a handful of extra ER visits any day if it speeds up innovation and saves lives.