Medtronic gains US FDA nod to apply AccuRyhthm algorithms to Reveal LINQ ICM


Medtronic has announced US Food and Drug Administration market clearance to apply the AccuRhythm AI algorithms to the Reveal LINQ insertable cardiac monitor (ICM), the predecessor to the LINQ II ICM, via cloud-based updates.

Medtronic anticipates the AccuRhythm AI algorithms to reduce approximately 89.5% of atrial fibrillation (AF) false alerts and 80.2% of pause false alerts with Reveal LINQ, while preserving true alerts at a rate of 98.2% and 99.9%, respectively. Healthcare providers have used the Reveal LINQ ICM to care for more than 750,000 patients globally since 2014. The AccuRhythm AI update for the Reveal LINQ ICM will also be available in Europe.

“Adding AccuRhythm AI to the thousands of Reveal LINQ ICMs currently implanted in patients globally is important as it will help reduce the data burden on many hospitals and clinics that still regularly use this device for monitoring their patients,” said Alan Cheng, vice president and chief medical officer for Cardiac Rhythm Management Operating Unit, which is part of the Cardiovascular Portfolio at Medtronic.

Medtronic developed the AccuRhythm AI platform and algorithms using its proprietary, diverse and debiased database of more than one million electrocardiogram heart rhythm episodes. Medtronic will continue to apply AccuRhythm AI in the cloud automatically to facilitate seamless care for patients. The AccuRhythm AI algorithms for the Reveal LINQ ICM and updated AF algorithm for LINQ II are anticipated to go live later this year.


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