I have heard conflicting stories about whether or not the new heart monitor sensors are FDA approved. Are they? If not, is Apple trying to get approval for them?
I have heard conflicting stories about whether or not the new heart monitor sensors are FDA approved. Are they? If not, is Apple trying to get approval for them?
It will be very beneficial for monitoring heart issues, but doctors may not want patients with aFib using this as the key way to monitor. I can't recall the article but I know I read something about that earlier this week. I will have to go back over my past reading.
How likely is the possibility of false negatives?... Has Apple or Stanford published the rate of false negatives in their study?
Apple submitted findings from two studies to the FDA as part of its submission to obtain clearance for the ECG app. According to STAT News, which obtained a summary of the findings from the FDA, the watch algorithm accurately identified 98.3 percent of people with atrial fibrillation, and correctly identified 99.6 percent of people who did not have atrial fibrillation. The study's sample size was 588 people.
n one study, Apple tested the watch in more than 580 people, half of whom had atrial fibrillation. The app couldn’t read about 10 percent of the heart rhythm recordings in the study. When it looked at the rest, though, the app was very accurate: It caught more than 98 percent of people with atrial fibrillation, and correctly told people that they didn’t have the condition 99.6 percent of the time.
That figure is the app’s “positive predictive value,” and Kathiresan calculates that for people using Apple’s EKG app to look for atrial fibrillation, that number is about 45 percent. He based that calculation on the figures from the studies FDA shared.More than half the time the app flags a problem, then, the app will be wrong.
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Doctors whose patient populations sport Apple Watches may need to brace themselves for an influx of patients who will want to see a specialist when they receive an irregular heart rhythm alert, Kathiresan said.
False negatives are more dangerous because they mean you are getting an assurance that is not correct. Then, even if you have mild symptoms, you might ignore them because the watch ays you have nothing to worry about.
The concern seems to be coming from how limited the data was, that Apple controlled the data and they knew who had aFib in the trial which is something you should not know.