Implicity's ILR ECG Analyzer Receives 510(k) Clearance from FDA


Implicity announced their ILR ECG Analyzer received 510(k) clearance from the FDA in a statement released on December 16.

FDA in white letters over a modern blue back drop

With the recent explosion in use of implantable loop records (ILRs), the FDA’s clearance of a novel medical algorithm from Implicity could help improve care of patients using these devices.

Announced on December 16, 2021, the 510(k) clearance was awarded to Implicity’s IRL ECG Analyzer, which is compatible with all Medtronic ILRs previous to the LINQ II model, including Reveal LINQ, Reveal XT, and Reveal DX.

"This is an important step for Implicity as we expand in the US market," said Arnaud Rosier, MD, PhD, the 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.”

According to Implicity, the device uses artificial intelligence to heart rhythm data collected by Medtronic ILRs to provide additional signal processing and analysis to improve the accuracy of irregular heartbeat detection. Information collected is automatically classified by the device to help prioritize true events, which manufacturers suggest could help provide more meaningful and efficient event management.

"Excessive false positives from ILRs 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," said Arnaud Lazarus, MD, an electrophysiologist at Clinique Ambroise Paré.

A recent study published in the European Heart Journal underlines the potential impact use of the ILR ECG Analyzer could have on reducing the number of false-positives episodes without compromising sensitivity. In the study, which included 370 patients from 20 medical centers in Europe, Implicity’s novel algorithm reduced the number of false-positive episodes by 79% in patients implanted with Medtronic ILRs while maintaining 99% sensitivity.

"I am excited by the potential this technology has to transform the practice of remote patient monitoring," said Niraj Varma, MD, PhD, a professor of medicine and consultant electrophysiologist at the Cleveland Clinic, in the aforementioned statement. "The true promise of remote monitoring is that we can see patients who need to be seen earlier. Even if the patient is not experiencing a symptom, we can detect their condition and let them know they need to be seen. Implicity's innovative solutions will enable us to direct our attention to clinically actionable data better so we can do just that."

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