- Cardiologist says Apple Watch’s new ECG functionality could be “unbelievably helpful” for AFib patients, but expresses “shock” at FDA clearance since “I haven’t seen any data on it.” Could revolutionize care — or clog ERs with false alarms.
- According to the Food and Drug Administration, which cleared Apple’s monitor and electrocardiogram applications, the continuous monitoring and notification app isn’t for people under age 22 or those diagnosed with atrial fibrillation.
Via STAT news “Apple claims that its optical sensor algorithms can detect atrial fibrillation, and the watch will warn users when it thinks they are in this dangerous heart rhythm based on what the optical sensor says. That may send a lot of people whose hearts are doing perfectly fine to their doctors for unnecessary and potentially harmful testing”
We also don’t know how accurate the Apple electrocardiograms are. I’m shocked that the FDA cleared this application since I haven’t seen any data on it.
I called three well known cardiologists that I know very well and while they welcome the Apple watch to help patients monitor their own health not one said they would make a diagnosis from its data. They also said they would need to see a lot more data to give the watch a thumbs up.
When I asked about the FDA approving the device they said “frankly that doesn’t mean a hell of lot”. Each one of them said that they would do their own tests if a patient came in with an alert from the watch. On doctor, in L.A. said “great, now I’ll have hypochondriacs lining up in my waiting room.
It seems that companies like Apple haven’t yet learned that the medical world revolves around hard data and even that may not be enough. Doctors, in addition to the hard data, want proof that patients will use devices as instructed and that they do indeed provide better outcomes.