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FDA Down-Classifies Another App Linked To Apple Watch

Agency finalizes order allowing sponsors to submit 510(k) applications for photoplethysmograph analysis software less than a month after doing same for another Apple-led app.

An Apple Watch measuring heartbeat
AN APPLE WATCH MEASURES A USER'S HEARTBEAT. • Source: Alamy

The US Food and Drug Administration is allowing sponsors to use the 510(k) pathway for photoplethysmograph analysis software two years after the agency authorized using, in an app Apple markets as part of its health suite on its Apple Watch, the analysis which detects blood volume changes in the skin to measure a user’s heart rate and blood volume.

In a final order published the the 4 February Federal Register, the FDA said it codified its decision to classify OTC photoplethysmograph analysis software as class II devices with...

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