Apple Watch's AFib detection tool earns landmark FDA approval

May 3, 2024 By Sean Whooley

The FDA granted the AFib detection tool within the Apple Watch a new qualification through its Medical Device Development Tools (MDDT) program.

Apple's AFib History feature now becomes the first digital health technology qualified under the MDDT program. It provides a non-invasive way to check estimates of AFib burden within clinical studies.

According to an FDA bulletin, the tech giant designed its feature as a biomarker test to evaluate estimates of AFib burden. It looks at AFib burden as a secondary effectiveness endpoint within clinical studies. This helps to evaluate the safety and effectiveness of cardiac ablation devices used to treat AFib.

The FDA says Apple offers the feature for use throughout the clinical study, both before and after cardiac ablation device use. It helps to monitor the participant's weekly estimate of AFib burden.

Apple first received FDA 510(k) clearance for its irregular heart rhythm notification on its watch in November 2021. However, the technology has been subject to some legal issues in recent years as companies like Masimo and AliveCor both challenged the technology's health tracking features.

AliveCor first unveiled its ECG-equipped KardiaBand that detects AFib for Apple Watch in March 2016. The thin wristband, designed specifically for the Apple Watch, provides single-lead ECG readings and diagnostics. Users can view data through an app, with results sent to managing physicians. AliveCor sued Apple over the IP of its ECG technology in 2020. The case continued this year with a court allowing AliveCor a stay in the legal proceedings.

Masimo, meanwhile, challenged the company's pulse oximetry feature for the watch. There is currently a pause on an Apple Watch import ban as a result of patent litigation between the companies.

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.