Algorithm to analyze ECG data from implantable loop recorders cleared by FDA
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Implicity announced the FDA cleared its algorithm analyzing ECG data from implantable loop recorders.
Implantable loop recorders are used to detect atrial fibrillation in patients at high risk for stroke, but can produce false-positive results, so the algorithm (ILR ECG Analyzer) uses artificial intelligence to help doctors better interpret the data, according to a press release issued by the company.
“Excessive false positives from (implantable loop recorders) are very common. There’s a high positive rate with many events that are considered arrhythmias, that in fact, are not arrhythmias. These false positives significantly burden clinicians who need to sift through the noise and adjudicate misclassified abnormalities. Implicity’s algorithm significantly reduces this workload,” Arnaud Lazarus, MD, electrophysiologist at Clinique Ambroise Paré, Neuilly sur Seine, France, said in the release.
Medtronic, the largest manufacturer of implantable loop recorders, has an algorithm for its most current model, Reveal LINQ II, but the Implicity algorithm is compatible with previous models such as Reveal LINQ, Reveal XT and Reveal DX, according to the release.
Clearance was based on a study showing the algorithm reduced false-positive episodes by 79%, the company stated in the release.
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