Implicity Receives FDA Clearance for Novel Heart Failure Prediction Algorithm

Implicity, a leader in remote patient monitoring and cardiac data management solutions, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new groundbreaking algorithm, SignalHF1, used in its remote monitoring solution.

Implicity was the first private company authorized to access the Health Data Hub, one of the largest databases of patients with heart disease globally. 

Leveraging this and comprehensive datasets from its AI-based remote monitoring platform, Implicity's team trained and validated a machine learning algorithm capable of assessing the risk of future heart failure events, enabling physicians to intervene before a patient requires hospitalization.

"Heart failure remains a significant healthcare challenge, contributing to approximately one million hospitalizations each year."

SignalHF is an innovative and effective tool that physicians can use to assess the 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 can analyze data collected from various 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.

It is the first pacemaker-compatible heart failure algorithm on the market. The algorithm accurately identifies trends indicating whether a patient's condition is worsening. Care teams receive automatic alerts when the patient's risk score crosses an established threshold, indicating a high risk of experiencing heart failure and being hospitalized in the near future.

"Comprehensive heart failure management includes treatment, prevention, and personalization”. Alerts are generated in context with a patient's medical profile to help personalize care management plans.





Harvard Medical School - Leadership in Medicine Southeast Asia47th IHF World Hospital Congress