FDA OKs Implicity’s New Heart Failure Prediction Algorithm

Implicity has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for the SignalHF algorithm used in its remote monitoring solution.
 
SignalHF is a manufacturer-agnostic solution that analyzes data collected from a variety of cardiac implantable electronic devices, including ICDs, pacemakers, and CRT-P/CRT-D devices from Biotronik, Boston Scientific, and Medtronic. According to Implicity, it’s the first pacemaker compatible heart failure algorithm on the market.
 
The algorithm identifies trends indicating whether condition is worsening. An automatic alert is sent to care teams when the patient’s risk score exceeds an established threshold, showing there’s a high risk of experiencing heart failure and being hospitalized in the near future.
 
“Heart failure remains a significant healthcare challenge, contributing to approximately one million hospitalizations each year. Preventing even a portion of these would be a game-changer in cardiac care,” said Dr. Arnaud Rosier, Implicity’s CEO and cardiologist. “SignalHF is an innovative and effective tool that physicians can use to assess risk of hospitalization due to heart failure earlier, enabling interventions that can lead to better outcomes and reduce hospital admissions.”
 
Further, Implicity was the first private company authorized to access the Health Data Hub, one of the largest databases of heart disease patients in the world. Based on the Health Data Hub complete medico-administrative database and comprehensive datasets from Implicity’s AI-based remote monitoring platform, the Implicity team trained and validated a machine learning algorithm that assesses the risk of future heart failure events, allowing intervention before a patient needs to be hospitalized.
 
“Comprehensive heart failure management includes treatment, prevention, and personalization. Implicity’s solution is part of this approach. Our alerts are generated in context with a patient’s medical profile to help personalize care management plans. Furthermore, 75% of the alerts preceding a patient hospitalization are sent at least 14 days in advance—offering a two-week window to adjust medications or take proactive measures,” said Issam Ibnouhsein, Head of Data at Implicity.