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July 29, 2021updated 04 Aug 2021 6:43am

FDA approves Medtronic’s AI algorithms for cardiac monitoring

The AI algorithms lower AF and asystole false alerts provided by the LINQ II insertable cardiac monitor.

The US Food and Drug Administration (FDA) has granted clearance to Medtronic’s two artificial intelligence (AI) algorithms for use with the LINQ II insertable cardiac monitor (ICM).

The AccuRhythm AI algorithms use AI to enhance the precision and accuracy of heart rhythm event data captured using LINQ II. With better data, doctors will be able to improve the diagnoses and treatments of abnormal heart rhythms.

The Cloud-based AccuRhythm AI algorithms will improve the precise heart rhythm alert delivery of the small, wireless LINQ II ICM device.

Medtronic noted that the AI algorithms tackle the two most common ICM false alerts, atrial fibrillation (AF) and asystole.

AF is an irregular or quick rhythm in the upper heart chambers, while asystole is a lengthy pause between heartbeats.

Leveraging a varied and debiased database of over one million electrocardiogram heart rhythm episodes, the company developed the AccuRhythm AI platform and preliminary algorithms.

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Medtronic cardiovascular diagnostics and services business chief medical officer Rob Kowal said: “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.”

In validation studies, the AccuRhythm AI AF algorithm lowered LINQ II ICM’s false alerts of AF by 74.1% and maintained 99.3% of correct alerts.

Furthermore, the Pause algorithm decreased LINQ II false pause alerts by 97.4% and maintained 100% of the right alerts.

Medtronic noted that the AccuRhythm AI algorithms will be launched on the CareLink Network this year and can be utilised by all implanted LINQ II devices in the US.

The development comes after Medtronic introduced its CE marked Prevail drug-coated balloon (DCB) catheter in Europe for the treatment of coronary artery disease (CAD) patients.

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