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Medtronic announced Wednesday that the FDA cleared two AccuRhythm artificial intelligence (AI) algorithms for use with the LINQ II insertable cardiac monitor (ICM) to address atrial fibrillation (AF) and asystole (Pause). The AF and Pause algorithms, which also had validation data for them presented at the Heart Rhythm Society's (HRS) annual meeting, will be released on the CareLink Network later this year for use by all implanted LINQ II devices in the US.
Rob Kowal, chief medical officer of Medtronic's cardiovascular diagnostics and services business, remarked that "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."
Validation data for the AF algorithm presented at the conference included an analysis of 5025 ICM-detected AF episodes from 147 LINQ II patients, comprising 2186 total AF alerts. Results showed that the AF algorithm reduced false AF alerts by 74.1% and preserved 99.3% of true AF alerts. Meanwhile, data on the Pause algorithm came from 382 patients with 2766 pause episodes, including sinus asystole and AV block. The algorithm reduced LINQ II false pause alerts by 97.4% and preserved all true alerts.
The cloud-based algorithms apply AI to heart rhythm event data collected by LINQ II to enhance the ICM's delivery of accurate heart rhythm alerts. According to Medtronic, the AccuRhythm AI platform and initial algorithms were developed using its database of more than 1 million electrocardiogram heart rhythm episodes.
"Integrat[ing] AI capabilities to further elevate the accuracy of LINQ II ICM [will] provide clinicians with greater confidence in patient care decisions," said Julie Brewer, who is president of the cardiovascular diagnostics and services business, adding "we look forward to introducing additional diagnostic innovations to advance patient management in the future."
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