AHI System
Fifth Eye Inc.The AHI System is a software tool that helps healthcare professionals monitor adult patients' cardiovascular status by analyzing ECG signals to detect signs of current hemodynamic instability and predict future episodes. It provides continuous updates and color-coded alerts for clinicians to increase vigilance and improve patient care.
Intended Use
The AHI System is intended for use by healthcare professionals managing patients 18 years or older who are receiving continuous physiological monitoring with electrocardiography (ECG) in hospitals to describe a patient's hemodynamic status and indicate signs of stability or instability.
Technology
The system analyzes lead-II ECG waveform data using AI to detect signs of hemodynamic instability and predicts likelihood of future instability episodes using outputs from the analytics. It provides binary and risk-level outputs updated frequently, incorporating heart rate variability and ECG morphology features.
Performance
Clinical validation compared AHI-PI outputs to invasively monitored vital signs in hospitalized patients, demonstrating significant discrimination between risk groups and showing the high-risk indicator to be 51 times more likely to predict hemodynamic instability in the next hour. A median lead time of 48 minutes for prediction was reported, with positive results from software verification, usability studies, and clinical data.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/16/2021
4 months - 2
FDA Approval
12/3/2021
Other devices from Fifth Eye Inc.
- Analytic for Hemodynamic Instability (AHI)2021 • DE NOVO
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