Implicity receives FDA clearance for AI-Powered ECG analyser

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Implicity has announced US Food and Drug Administration (FDA) clearance for a novel medical algorithm that analyses ECG data from implantable loop recorders (ILRs).

“This is an important step for Implicity as we expand in the US market,” said Arnaud Rosier, CEO and founder of Implicity. ”With FDA clearance, our AI product can now be used in combination with implantable loop recorders to improve arrhythmia detection and help electrophysiologists and their teams avoid wasting time reviewing non-actionable events.”

“Excessive false positives from ILRs are very common. There is 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,” said Arnaud Lazarus, electrophysiologist at Clinique Ambroise Paré, Neuilly-sur-Seine, France

Medtronic recently announced an AI algorithm to address the false positive issue, but it is only for use with the LINQ II model.  Implicity’s solution is compatible with all previous Medtronic models (i.e. Reveal LINQ, Reveal XT, and Reveal DX), which are implanted in the majority of patients.


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