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Implicity Secures FDA Clearance for Innovative Heart Failure Prediction Algorithm

NextEdge Admin

20 May 2024

3 min 7 sec

Implicity, a leading provider of remote patient monitoring and cardiac data management solutions, has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its innovative algorithm, SignalHF*. This groundbreaking algorithm, integrated into Implicity’s remote monitoring solution, is designed to assess the risk of future heart failure events based on comprehensive patient data.

As the first private company granted access to the Health Data Hub, one of the largest heart disease patient databases globally, Implicity leveraged this resource alongside data from its AI-based remote monitoring platform to train and validate SignalHF. This machine learning algorithm enables physicians to predict the risk of heart failure-related hospitalizations, facilitating timely interventions to improve patient outcomes.

Dr. Arnaud Rosier, CEO of Implicity and a cardiologist, emphasized the significance of SignalHF in addressing the healthcare challenges posed by heart failure. By enabling early risk assessment and intervention, SignalHF has the potential to reduce the approximately one million heart failure-related hospitalizations annually.

SignalHF stands out as a manufacturer-agnostic solution capable of analyzing data from various Cardiac Implantable Electronic Devices (CIED), including pacemakers, implantable cardiac defibrillators (ICD), and cardiac resynchronization therapy devices (CRT-P, CRT-D) from major manufacturers like Biotronik, Boston Scientific, and Medtronic. Notably, SignalHF is the first pacemaker-compatible heart failure algorithm available.

Implicity’s platform provides care teams with automatic alerts when a patient’s risk score indicates a high likelihood of imminent heart failure-related hospitalization. These alerts are personalized based on the patient’s medical history and data trends, allowing for tailored care management plans. Moreover, the platform’s proactive alerts are often issued at least 14 days before hospitalization, offering a valuable window for adjusting medications or implementing preventive measures.

Implicity’s remote monitoring and research platform serve Independent Diagnostic Testing Facilities and cardiac electrophysiology centers, enhancing the quality of care for patients with Cardiac Implantable Electronic Devices by aggregating, normalizing, and standardizing data across all device manufacturers.