Apple has made clear that it wants to play a role in the health care market, and now, it’s one step closer to looking and feeling like a true health device maker.
The US Food and Drug Administration (FDA) has awarded medical device development tool (MDDT) status to the Apple Watch’s atrial fibrillation (AFib) history tracker. The feature is first piece of digital health technology to earn MDDT status, the FDA said in a statement.
The FDA’s MDDT program is designed to provide guidance to the medical community on which devices they can use to accurately analyze patient health. The program includes a slew of devices, including biomarker tests, assessment models, and sensors.
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AFIb is an arrhythmia, or irregular heartbeat, that occurs in the upper chambers of the heart and causes it to beat rapidly and in irregular patterns. Apple has for years offered AFib History tracking on the Apple Watch. The feature sends a weekly recap of AFib frequency to Apple Watch users, along with detailed data in the Apple Health app on how certain activities, including sleep, alcohol consumption, and exercise factor into their AFib activity.
The feature has proven especially useful to those who have been diagnosed with an irregular heartbeat and want to see how often they enter AFib. The Apple Watch is also capable of detecting irregular heartbeats, though it’s the history feature that lets users look back at their arrhythmias, for which the FDA has awarded MDDT status.
This isn’t the first FDA honor for Apple’s AFib history tracker. In 2022, the FDA said that the feature had earned 510(k) clearance, letting users aged 22 and older review their AFib history in a clinical setting. The move effectively meant that Apple’s tool could be counted on to accurately predict AFib, based on the FDA’s testing.
In addition to AFib history tracking, the Apple Watch ships with a host of health tracking features, including the ability to run an echocardiogram on your heart, determine your heart rate, and even evaluate your blood oxygen levels. Only the Apple Watch Series 6 and later models have all these features. AFIb history tracking, for instance, isn’t available on older models.
Rumors continue to suggest that Apple wants to add more health care features to its smartwatch. Several reports have said Apple’s next Apple Watch update could offer blood pressure tracking.
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