The FDA announced the The Apple Watch Atrial Fibrillation Tool (AFib) is qualified for use in clinical trials through its Medical Device Development Tools (MDDT) program, allowing researchers to use it to detect arrhythmias or abnormal heartbeats.
Apple’s tool is the first digital health tool qualified under the MDDT program, a voluntary program aimed at evaluating devices for use in medical research.
The FDA said the feature is intended for use in clinical trials as a biomarker test to determine AFib burden as an endpoint to evaluate the safety and effectiveness of cardiac ablation devices and monitors the weekly estimate of AFib burden of participants.
THE BIGGEST TREND
In February, Apple won a long battle over wearable heart monitoring technology against AliveCor, a medical device company that makes personal ECGs.
Apple and AliveCor have been in a legal battle over AliveCor’s claim that Apple is illegally monopolizing the US market for heart rate monitoring apps and infringing its patents.
A U.S. district judge in California dismissed AliveCor’s lawsuit, although the judge’s reasoning behind the dismissal is being kept under wraps. AliveCor said he plans to appeal the decision.
The company has been in a legal battle for the past few months over another of its watch’s health-focused features: blood oxygen sensors.
Medical technology company Masimo southern Apple in 2020 for allegedly poaching its employees and stealing trade secrets related to technology that uses light to measure blood oxygen levels on the Apple Watch.
In October, Apple was banned from selling and importing its smartwatches after the International Trade Commission issued an order to protect Masimo.
President Biden had 60 days to review and revoke the ITC order preventing Apple from selling its watches, but was unable to veto the ban before the deadline.
Apple later He filed an appeal with the U.S. Court of Appeals for the Federal Circuit, and on Jan. 15 the court reinstated the ban.
Shortly after, Apple found a solution to the ban by modifying its watches so that they do not include the disputed blood oxygen feature. The case is ongoing.