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Medtronic Awarded FDA Clearance for 2 AI Algorithms for Cardiac Monitoring

by Fred Pennic 07/30/2021 Leave a Comment

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medtronic

What You Should Know:

– Medtronic announced U.S. Food and Drug Administration (FDA) clearance for two AccuRhythm™ AI algorithms for use with the LINQ II™ insertable cardiac monitor (ICM) – and the presentation of AccuRhythm AI validation data this week at Heart Rhythm 2021.

– AccuRhythm AI applies artificial intelligence (AI) to heart rhythm event data collected by LINQ II, improving the accuracy of information physicians receive so they can better diagnose and treat abnormal heart rhythms.

AccuRhythm AI Benefits

The small, wireless LINQ II ICM is the world’s most accurate ICM,1-4 and the new cloud-based AccuRhythm AI algorithms further enhance LINQ II ICM’s delivery of accurate heart rhythm alerts. The algorithms address the two most common ICM false alerts – atrial fibrillation (AF), an irregular or rapid rhythm in the upper chambers of the heart; and asystole, a long pause between heartbeats. 5-6 Medtronic developed the AccuRhythm AI platform and initial algorithms using its proprietary, diverse and debiased database of more than 1 million electrocardiogram heart rhythm episodes.

AccuRhythm AI Validation Results 

AccuRhythm AI validation results to be presented at Heart Rhythm 2021 include:

– The AF algorithm reduced LINQ II ICM false AF alerts by 74.1% and preserved 99.3% of true AF alerts.
– The Pause algorithm reduced LINQ II false pause alerts by 97.4% and preserved 100% of true pause alerts.

Availability

The AccuRhythm AI algorithms will be released on the CareLink™ Network later this year for use by all implanted LINQ II devices in the United States.

“Applying AccuRhythm AI to LINQ II data is a significant ICM innovation, enabling us to reduce clinical inefficiencies resulting from false alerts, and help physicians better identify and focus on the actionable data they need to treat their patients,” said Rob Kowal, M.D., Ph.D., chief medical officer of the Cardiovascular Diagnostics and Services business, which is part of the Cardiovascular Portfolio at Medtronic.

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Tagged With: AI, algorithms, Artificial Intelligence, Cardiac Monitoring, FDA, FDA Clearance, Medtronic

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