“Now, the company is expected to take these health ambitions a step further by introducing an electrocardiogram or ‘ECG’ sensor that measures the heart’s rhythm — and not just the heart rate,” Farr reports. “Apple releasing an ECG is a big deal for people with certain diseases. But it’s also complicated because the company would need to figure out how to communicate sensitive medical information to consumers without freaking them out. The last thing Apple would want to do with its device is send tens of thousands of anxious users into the emergency room thinking they’re having a life-threatening medical problem when they’re not.”
“Will Apple need approval from federal regulators? It depends. If Apple shows the ECG reading to a consumer, then yes. That would make the Apple Watch a regulated medical device,” Farr reports. “But Vic Gundotra, CEO of AliveCor, a start-up making big waves in the space, sees another path. He suggests that the company could use the ECG to get more accurate heart rate data, which wouldn’t necessarily require an approval process. ”
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