You're right, but it is actually not the general class 2 that electrocardiographs are under, it's Class II (performance standards). And yes, the FDA will requi

You're right, but it is actually not the general class 2 that electrocardiographs are under, it's Class II (performance standards). And yes, the FDA will require pre-market clinical data. The FDA required a clinical study for the Apple Watch ECG: https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180044.pdf https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180044.p... Apple also ran the Apple Heart Study which had 419,000 subjects to validate the algorithm: https://www.nejm.org/doi/full/10.1056/NEJMoa1901183 https://www.nejm.org/doi/full/10.1056/NEJMoa1901183 Median cost for a U.S. pivotal cardiovascular‑device trial: ≈ $19 million: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2810822 https://jamanetwork.com/journals/jamanetworkopen/fullarticle... You're right that a company like Apple could afford it. However, the type of small company or small group that would form the base of a hacker culture cannot afford these kinds of clinical studies just for an experimental product. We need more experimental products being used in the market to get a faster rate of innovation. "NOTE that they allow many products to register as investigative!" Receiving the Investigational Device Exemption does NOT allow the device to be commercially sold or mass-distributed to the general public. The IDE just lets the device be used in human clinical trials. That's it.