The US Food and Drug Administration (FDA) has issued 510(k) approval to Implicity’s heart failure prediction algorithm, SignalHF1, designed to work with its remote monitoring solution.
Implicity is said to have leveraged one of the world's largest heart disease patient databases, Health Data Hub, to train and validate its machine-learning algorithm.
The SignalHF1 algorithm is capable of assessing the risk of future heart failure events, thus enabling timely intervention by physicians to prevent hospitalisations.
Implicity CEO and cardiologist Dr Arnaud Rosier said: “Heart failure remains a significant healthcare challenge, contributing to approximately one million hospitalisations each year. Preventing even a portion of these would be a game-changer in cardiac care.
“SignalHF is an innovative and effective tool that physicians can use to assess the risk of hospitalisation due to heart failure earlier, enabling interventions that can lead to better outcomes and reduce hospital admissions.”
The SignalHF1 algorithm can analyse data collected from various cardiac implantable electronic devices (CIEDs), including implantable cardiac defibrillators (ICD), pacemakers (PM) and cardiac resynchronisation therapy devices (CRT-P, CRT-D) from companies such as Biotronik, Boston Scientific, and Medtronic.
It is also said to be the first compatible algorithm with pacemakers.
The algorithm automatically alerts care teams when a patient's risk score exceeds a certain threshold, indicating a high risk of imminent heart failure and potential hospitalisation.
Implicity data head Issam Ibnouhsein said: “Comprehensive heart failure management includes treatment, prevention, and personalisation. Implicity's solution is part of this approach. Our alerts are generated in context with a patient's medical profile to help personalise care management plans.
“Furthermore, 75% of the alerts preceding a patient hospitalisation are sent at least 14 days in advance – offering a two-week window to adjust medications or take proactive measures.”
Last year, Implicity launched a new algorithm for reducing alert fatigue in the remote monitoring of patients with atrial fibrillation.
