FDA clears AI algorithm for detection of worsening HF
Key takeaways:
- The FDA cleared an AI algorithm for the detection of worsening HF and imminent hospitalization.
- The algorithm sends an alert to the patient’s care team when risk scores reach an established threshold.
Implicity announced it received 510(k) clearance from the FDA for its new AI algorithm to assess risk for future HF events from data gathered from various cardiac implantable electronic devices.
The algorithm (SignalHF) was trained and validated using the Health Data Hub, one of the largest CVD databases in the world, and datasets from the company’s AI-based remote monitoring platform, according to a press release from the company.
The AI algorithm is designed to analyze data from cardiac implantable electronic devices, including implantable cardiac defibrillators, pacemakers and cardiac resynchronization therapy devices from Biotronik, Boston Scientific and Medtronic, and is the first pacemaker-compatible HF algorithm on the market, according to the release.
Using these data, the AI assesses for worsening trends in a patient's condition, indicating high risk for experiencing HF and being hospitalized in the near future, and issues an automatic alert to the care team when the patient's risk score crosses an established threshold.
“Our alerts are generated in context with a patient's medical profile to help personalize care management plans. Furthermore, 75% of the alerts preceding a patient hospitalization are sent at least 14 days in advance — offering a 2-week window to adjust medications or take proactive measures,” Issam Ibnouhsein, head of data at Implicity, said in the release.
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