Fitbit Irregular Heart Rate Notification Software Cleared For Use In US
Software for Google’s Fitbit identifies atrial fibrillation using a photoplethysmography algorithm to detect tiny changes in blood volume with its optical sensor.
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US regulators have officially down-classified adjunctive predictive cardiovascular indicator software to class II as part of a trend to make it easier for sponsors to apply for premarket applications.
The agency has codified its over-the-counter ECG software class II classification, which means sponsors can continue to benefit from filing for such apps through the less burdensome 510(k) pathway.
Fitbit will launch its new Fitbit Sense smartwatch with ECG app in Europe, US, Hong Kong and India in October.