AccuRhythm AI algorithms gain US FDA clearance

Medtronic’s Reveal LINQ implantable cardiac monitor

Medtronic has announced US Food and Drug Administration (FDA) clearance for two AccuRhythm AI algorithms for use with the LINQ II insertable cardiac monitor (ICM). The algorithms address the two most common ICM false alerts—atrial fibrillation (AF) and asystole.

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 validation data will be presented this week at the 2021 Heart Rhythm Society annual meeting (HRS 2021, 28–31 July, Boston, USA and virtual).

Medtronic developed the AccuRhythm AI platform and initial algorithms using its proprietary database of more than 1 million electrocardiogram heart rhythm episodes.

“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, chief medical officer of the Cardiovascular Diagnostics and Services business, which is part of the Cardiovascular Portfolio at Medtronic.

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

“We are excited to integrate AI capabilities to further elevate the accuracy of LINQ II ICM—and provide clinicians with greater confidence in patient care decisions,” said Julie Brewer, president of the Cardiovascular Diagnostics and Services business at Medtronic. “We look forward to introducing additional diagnostic innovations to advance patient management in the future.”


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