FDA approval of Apple Watch ECG feature based on Apple Heart Study data: report

Apple's recently unveiled electrocardiogram (ECG) feature on the fourth-generation Apple Watch was granted a De Novo classification by the FDA partly based on data from the Apple Heart Study, Quartz reported. The company launched the trial last December, saying it was "a first-of-its-kind research study using Apple Watch's heart rate sensor to collect data on irregular heart rhythms and notify users who may be experiencing atrial fibrillation."

Apple Watch users in the US aged 22 years or older were eligible to participate in the trial. For the ECG clearance, the FDA reviewed data from the study of 588 participants, half of whom had atrial fibrillation, while the rest were healthy. Results showed that the Apple Heart Study app was able to identify more than 98 percent of participants who had atrial fibrillation and over 99 percent of those with healthy heart rates. Meanwhile, cardiologists could interpret 90 percent of the total readings, while roughly 10 percent were unreadable.

For the irregular heart-rate notification clearance, the FDA looked at data from a subset of the study involving 226 participants who had been flagged as having atrial fibrillation. Patients were followed for six days on the app and an ambulatory monitor. The findings showed that the ambulatory monitor detected whether a participant had experienced atrial fibrillation in around 40 percent of cases. Further, when the Apple Watch signalled atrial fibrillation during the follow-up period, the ambulatory monitor came to the same conclusion 78.9 percent of the time.

In the FDA's approval letters, the regulator classified the app as a Class II device and highlighted the risks of inaccurate readings, while mandating that Apple label those risks, warning users when the watch may not work. The FDA also cautioned that the device "is not intended to provide a diagnosis."

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