Implicity's Heart Failure Prediction Algorithm Receives FDA Clearance

Saturday, May 18, 2024

Implicity, a leader in remote patient monitoring and cardiac data management solutions, has announced the receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its groundbreaking algorithm, SignalHF1, incorporated into its remote monitoring system.

Being the first private company authorized to access the Health Data Hub, one of the largest databases of patients with heart disease globally, Implicity utilized this alongside data from its AI-powered remote monitoring platform to develop and validate a machine learning algorithm.

This algorithm assesses the risk of future heart failure events, enabling physicians to intervene proactively before hospitalization is necessary.

"Heart failure poses a significant healthcare challenge, resulting in approximately one million hospitalizations annually. The ability to prevent even a fraction of these incidents would revolutionize cardiac care," and cardiologist at Implicity.

"SignalHF represents an innovative and potent tool for physicians to assess the risk of heart failure-related hospitalizations earlier, facilitating interventions that can yield superior outcomes and reduce admissions."

SignalHF is unique in its manufacturer-agnostic nature, capable of analyzing data from various Cardiac Implantable Electronic Devices (CIED), such as implantable cardiac defibrillators (ICD), pacemakers (PM), and cardiac resynchronization therapy devices (CRT-P, CRT-D) from Biotronik, Boston Scientific, and Medtronic.

Notably, SignalHF marks the debut of a pacemaker-compatible heart failure algorithm in the market. It accurately discerns trends indicating deteriorating patient conditions.

Prompting care teams with automatic alerts when a patient's risk score surpasses a predetermined threshold, signaling a high likelihood of imminent heart failure and hospitalization.

"Effective heart failure management encompasses treatment, prevention, and personalization. Implicity's solution contributes to this holistic approach. Our alerts are contextualized within a patient's medical profile to facilitate personalized care management plans.

Moreover, 75% of alerts preceding patient hospitalizations are issued at least 14 days in advance, affording a two-week window for medication adjustments or proactive measures," elucidated Issam Ibnouhsein, Head of Data at Implicity.


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