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Apple Watch Feature Qualified As FDA Device Development Tool

 
• By Elizabeth Orr

The designation makes the watch's AFib history feature the first digital health tool to be qualified under the US FDA’s Medical Device Development Tools program, meaning it can be used in research during the development of certain cardiac devices.

APPLE WATCH HEART
• Source: Shutterstoc

The atrial fibrillation (AFib) history feature on Apple Watches can be used to track AFib during cardiac device clinical trials, the US Food and Drug Administration announced recently. It is the first digital health tool designated under the FDA’s Medical Device Development Tools (MDDT) program.

MDDT qualification means that the FDA has found a tool reliable enough to be used in device development without being...

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