The FDA announced that apple watch The Atrial Fibrillation (AFib) tool has been cleared for use in clinical trials through the Medical Device Development Tools (MDDT) program, allowing researchers to use it to detect arrhythmias and abnormal heartbeats.
Apple's tool is the first digital health tool to be certified under the MDDT program, a voluntary program aimed at evaluating devices for use in medical research.
According to the FDA, this feature is used in clinical trials as a biomarker test to determine atrial fibrillation burden as an endpoint to evaluate the safety and effectiveness of cardiac ablation devices, and is used in clinical trials to determine the atrial fibrillation burden in participants. He said it is designed to monitor weekly estimates of load.
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During February, apple The long-running battle for wearable heart monitoring technology has been won. alive corea medical device company that produces personal electrocardiograms.
Apple and AliveCor are in a legal battle over AliveCor's claims that Apple illegally monopolizes the U.S. market for heart rate monitoring apps and infringes the company's patents.
A federal district judge in California dismissed AliveCor's lawsuit, but the judge's reasons behind the dismissal are kept secret. AliveCor said it plans to appeal the decision.
The company has been in a legal battle over the past few months over the Watch's other health-focused feature, the blood oxygen sensor.
Medical technology company Masimo Sueed Apple in 2020 He is accused of poaching employees and stealing trade secrets related to Apple Watch technology that uses light to measure blood oxygen levels.
In October, Apple was banned from selling and importing smartwatches after the International Trade Commission issued a protective order for them. Masimo.
President Biden had 60 days to review and overturn the ITC's order blocking Apple from selling watches, but he was unable to veto the ban in time.
Apple after that filed an appeal The case was filed with the U.S. Court of Appeals for the Federal Circuit, which reinstated the ban on January 15.
Immediately after, Apple found a workaround It countered the ban by adjusting the clock so that it did not include the controversial blood oxygen function. The case is ongoing.