Apple Watch can now be used in AFib clinical studies thanks to new FDA approval

Apple has had a bumpy ride of late when it comes to its smartwatch division and its health monitoring features. In December, the company was forced to pause Watch Series 9 and Watch Ultra 2 (curr. $601 - renewed on Amazon) sales in the US because of an International Trade Commission (ITC) patent dispute involving Masimo. While Apple resumed sales of both smartwatches in the US, all Watch Series 9 and Watch Ultra 2 models sold from January onwards must have pulse oximetry disabled.

Now, the Food and Drug Administration (FDA) has approved Apple's atrial fibrillation (AFib) detection software for its Medical Device Development Tools (MDDT) program. In other words, the FDA is now allowing Apple's AFib technology to be used in clinical studies. For reference, AFib is a type of abnormal heartbeat, also known as arrhythmia.

The FDA adds that Apple's AFib history feature is the first digital health technology to qualify for its MDDT program. Moreover, the feature is designed throughout clinical studies to observe a participant's AFib burden weekly estimate, both before and after using cardiac ablation devices. Please see the FDA's official announcement for more details.