Apple Watch Gains FDA Approval for AFib Clinical Study Use

Apple's AFib detection software has been given FDA approval to be used in clinical trials. The regulatory body also notes that the first digital health technology to be approved for the Medical Device Development Tools (MDDT) program is Apple's AFib history feature.

Recently, Apple's smartwatch division and its health monitoring features have experienced some rough patches. A Masimo patent dispute with the International Trade Commission (ITC) forced the company to halt Watch Series 9 and Watch Ultra 2 (currently $601 - renewed on Amazon) sales in the US in December.

Although Apple has started selling both smartwatches again in the US, all Watch Series 9 and Watch Ultra 2 models that are sold starting in January need to have their pulse oximetry turned off.

Apple's atrial fibrillation (AFib) detection software for its Medical Device Development Tools (MDDT) program has now received FDA approval. Stated differently, the FDA has now approved the use of Apple's AFib technology in clinical research. As a point of reference, an arrhythmia, or irregular heartbeat, is what is referred to as AFib.

The FDA further states that the first digital health innovation to be approved for its MDDT program is Apple's AFib history feature.

Additionally, the feature is made to track a participant's weekly estimate of AFib burden before and after using cardiac ablation devices throughout clinical studies. For further information, please refer to the FDA's official announcement.