FDA clears AI software for limiting false-positive ICM alerts
Implicity, a Massachusetts-based medtech company, has received U.S. Food and Drug Administration (FDA) clearance for its new cloud-based artificial intelligence (AI) software designed to reduce false-positive alerts generated by implantable cardiac monitors (ICMs). This is Implicity’s third FDA clearance overall.
The next-generation ILR ECG algorithm is compatible with ICMs manufactured by Medtronic, Abbott, Biotronik, Boston Scientific and other leading names in that space. Recent studies published in EP Europace and Heart Rhythm link ILR ECG to significant reductions in false-positive alerts that did not have a negative impact on ICM sensitivity.[1, 2]
“Our vision is simple: AI should make expert cardiac care scalable without making it impersonal,” Arnaud Rosier, MD, PhD, CEO and co-founder of Implicity, said in a prepared statement. “Behind every patient monitored through Implicity is a clinician who can trust that the alert reaching them is one worth acting on. That's why our approach layers on top of manufacturer detection—with a cloud-based, manufacturer-agnostic AI that filters out the residual noise before it reaches clinical teams. We are proud to receive FDA clearance for this next-generation algorithm because it reflects our commitment to developing clinical-grade AI tools that are rigorously evaluated, workflow-ready, and trusted by cardiac electrophysiologists managing complex remote monitoring data.”
“False-positive alerts remain a major workflow obstacle as remote cardiac monitoring has continued to scale,” added Manish Wadhwa, MD, a cardiac electrophysiologist with Scripps Health. “Device-level filtering alone still leaves practitioners with volumes of non-actionable data to review, consuming significant time. A standardized, manufacturer-agnostic layer mitigates data noise and delivers consistency across patient populations, helping care teams prioritize events truly requiring clinical attention.”
Implicity expects the ILR ECG algorithm to be commercially available in the months ahead.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.