[capcarr]

Medical certification is something that we're not pursuing at the moment. For now, we intend to raise alerts to the user, in case we detect something suspicious, referring them to their medical doctor. We do not claim to detect cardiac pathologies that are rare, and need several ECG derivations to be correctly diagnosed.

What we do offer is the possibility of more frequent ECG monitoring, beyond the 10 second ECG exam that most people do only once or twice per year. For example, driving is a stressful environment, where a major cardiac event is more likely to occur. In a car with our technology, we would be able to detect when that event happens, thus preventing a crash by automatically stopping the car, and calling emergency services.

Regarding signal variability due to medication and other pathologies, that's something we have to account for, with robust feature extraction methods that are invariant to these changes, or adapt to them.

[atria]

I'm not familiar with European regulations, or medical procedures, but in the U.S., a medical diagnosis can only be made by a qualified licensed medical professional. Even making statements about diagnosing disease states via software or smartphones is enough to invoke an FDA response.