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FDA Down-Classifies Another App Linked To Apple Watch

The US regulatory agency has finalized an order allowing sponsors to submit 510(k) applications for photoplethysmograph analysis software. The move comes less than a month after it did the same for another Apple-led app.

An Apple Watch measuring heartbeat
An Apple Watch measuring heartbeat • Source: Alamy

The US Food and Drug Administration has published a final order allowing sponsors to use the 510(k) pathways for photoplethysmograph analysis software used to detect irregular heart rhythm. The decision comes two years after the agency authorized Apple’s photoplethysmograph analysis app on its Apple Watch.

Apple markets the app, which optically detects blood volume changes in the skin to measure the user’s heart rate and blood volume, as part of its health suite on its...

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