Medtronic gains FDA approval for AI models focused on cardiac monitoring
Medtronic has received FDA clearance for two advanced AI algorithms to be used with the company’s LINQ II insertable cardiac monitor (ICM).
The algorithms, designed as part of Medtronic’s AccuRhythm AI platform, address two areas known for causing false ICM alerts: atrial fibrillation (AFib) and asystole.
The AFib algorithm was found to reduce false alerts by 74.1%, and the asystole algorithm reduced false alerts by 97.4%.
“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,” Julie Brewer, president of Medtronic’s cardiovascular diagnostics and services business, said in a statement. “We look forward to introducing additional diagnostic innovations to advance patient management in the future.”
Additional findings from the clinical trial that helped Medtronic score these approvals are scheduled to be presented at Heart Rhythm 2021, the annual meeting of the Heart Rhythm Society.