Implicity Bags US FDA Nod For New heart failure Prediction Algorithm

Implicity announced that company has received 510(k) clearance from the US Food and Drug Administration (FDA) for SignalHF, a new groundbreaking algorithm used in its remote monitoring solution.

Implicity was the first commercial firm granted access to the Health Data Hub, one of the world's largest databases of people with heart conditions. Based on the Health Data Hub's 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 physicians to intervene before a patient requires hospitalization.

“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.”

SignalHF is unique in that it is a manufacturer-agnostic solution that can be used to analyze data from a wide range of Cardiac Implantable Electronic Devices (CIED), including implantable cardiac defibrillators (ICD), pacemakers (PM), and cardiac resynchronization therapy devices (CRT-P, CRT-D) from Biotronik, Boston Scientific, and Medtronic. SignalHF is the market's first heart failure algorithm that is compatible with pacemakers. The program can reliably detect trends that indicate whether a patient's condition is worsening. When a patient's risk score exceeds a certain threshold, care teams receive an automatic alert indicating that the individual is at high risk of developing heart failure and being hospitalized in the near future.