To get the approval from FDA for the ECG feature in the new Apple Watch Series 4, Apple had to provide data from a heart study in which many of the participants had AFib and half did not.
The study which is provided to the Drug and Food Administration showed that the Watch has around 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.
For the ECG clearance, the FDA reviewed a study conducted by Apple and Stanford University in California. This study, called the Apple Heart Study included 588 individuals, half of whom had AFib and the other half of whom were healthy. The app was able to identify over 98% of the patients who had AFib, and over 99% of patients that had healthy heart rates. Cardiologists were able to read 90% of the total readings, although about 10% of them were unreadable.
Apart from that small study, which has been reported concluded that the Watch is crude as compared to hospital tech.
In a health care facility, a patient would have 12 different stickers, or leads, placed all over her chest and on certain spots on her arm and leg, to give doctors a clear picture of the four chambers of her heart’s movement.
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.
Gosh: a $400 consumer device isn’t a substitute for hospital-grade equipment – who’d have thunk it?
In its approval letters (pdf), the FDA notified Apple of the risks of inaccurate readings, and has mandated that Apple label those risks, and warn users about when the watch may not work. It also stated that the watch is not a substitute for actual medical care, and that patients should not make any medical decisions based on their readings—they need to have them checked by an actual doctor.
The Apple Watch Series 4 has became available for pre-orders from yesterday morning, with delivery scheduled for 21st of September.
Picture Credits: 9To5Mac
