To get FDA approval for the ECG feature in the new Apple Watch Series 4, Apple had to provide data from a heart study in which half the participants had AFib and half didn’t.
The study provided to the Food and Drug Administration showed that the Watch was more than 98% accurate at detecting atrial fibrillation …
For some bizarre reason, a Quartz piece on this was headlined The new heart-monitoring capabilities on the Apple Watch aren’t all that impressive.
While that’s a small study, Katherine Foley’s angle is that the Watch is crude compared to hospital tech.
Gosh: a $400 consumer device isn’t a substitute for hospital-grade equipment – who’d have thunk it?
The new Apple Watch, however, has the equivalent of one lead on your wrist, the company’s website says. “The tech that Apple is working with is very rudimentary compared to what we’d do for someone in a hospital or health care setting,” Moore said. Although the watch can detect changes in the patterns of a person’s heart rate, these changes really only show a user if she has a heart rate that is too fast, too slow, or beating irregularly—signifying AFib. The watch won’t necessarily give the full picture a doctor would need to diagnose a medical issue.
Apple was able to carry out its own study because the device falls into what the FDA calls a ‘low to moderate risk’ category. The risk, in this case, is that someone experiencing strange sensations might be fooled into thinking it’s nothing serious if their Apple Watch ECG says all is well – or undergo unnecessary medical procedures if the Watch diagnoses AFib when none is present. The FDA requires Apple to warn users of the risk of misdiagnosis.
The Series 4 became available for pre-order this morning, with the first deliveries scheduled for September 21.
