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...
Welcome to HBW Insight
Create an account to read this article
Already a subscriber?