The FDA approves Apple Watch's heart monitoring tool for use in clinical trials

The FDA approves Apple Watch's heart monitoring tool for use in clinical trials



The FDA announced the Apple Watch atrial fibrillation (AFib) tool is qualified for use in clinical trials through its Medical Device Development Tools (MDDT) program, enabling researchers to use it to detect arrhythmias or abnormal heart beat. 

Apple’s tool is the first digital health tool to be qualified under the MDDT program, a voluntary program aimed at evaluating devices for use in medical research. 

The FDA said the feature is designed to be used 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 participants’ weekly estimate of AFib burden.

THE LARGER TREND

In February, Apple won a long-running 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 U.S. market for heart rate monitoring apps and infringing upon its patents.

A U.S. District Judge in California dismissed AliveCor’s lawsuit, though the judge’s reasoning behind the dismissal is being kept under seal. AliveCor said it plans to appeal the decision. 

The company has been in a legal battle over the past few months about another of its Watch’s health-focused features: blood oxygen sensors. 

Medtech company Masimo sued Apple in 2020 for allegedly poaching its employees and stealing trade secrets related to technology that uses light to measure blood oxygen levels in 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 overturn the ITC’s order that stopped Apple from selling its watches but failed to veto the ban by the deadline.

Apple subsequently 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 workaround to the ban by tweaking its Watches not to include the disputed blood oxygen feature. The case is ongoing. 



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