Home ยป FDA Approval Granted for Clinical Trials Utilizing AFib Data on Apple Watch

FDA Approval Granted for Clinical Trials Utilizing AFib Data on Apple Watch

The Food and Drug Administration (FDA) of the United States has announced that the AFib symptom checker tool in the Apple Watch has been approved through the Medical Device Development Tool (MDDT) criteria.
FDA states that the AFib feature in the Apple Watch is the first digital health device to receive certification in the MDDT and can help assess AFib symptoms for preliminary use in clinical trials.
The heart rate monitoring feature has been available since the Apple Watch Series 4, and in Thailand, it became operational on watchOS in 2021.
Source: 9to5Mac

TLDR: FDA approves AFib symptom checker tool on Apple Watch through MDDT criteria. Heart rate monitoring feature available since Apple Watch Series 4, now operational in Thailand on watchOS as of 2021.

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