FDA Radiology AI Devices

Viz HCM is a machine learning-based software designed to analyze 12-lead ECG recordings to detect signs of hypertrophic cardiomyopathy (HCM). It helps clinicians identify patients who may have HCM and need further clinical follow-up, supporting early detection though not replacing full diagnostic evaluation. The system includes an ECG analysis algorithm and a mobile app to present results, improving screening in routine cardiology care.

The Analytic for Hemodynamic Instability (AHI) is a software device that analyzes ECG signals to monitor patients' hemodynamic status, detecting signs of instability defined by low blood pressure combined with high heart rate. It provides clinicians with frequent, updated alerts to increase vigilance for patients at risk of hemodynamic deterioration, serving as an adjunctive monitoring tool alongside other patient data to improve early detection and patient management in clinical settings.

The Acumen Hypotension Prediction Index (HPI) Feature Software is a clinical decision support tool that uses arterial blood pressure waveform data and patient demographics to predict the likelihood that a patient will experience hypotension within 15 minutes. It provides clinicians real-time, adjunctive physiological insights to help anticipate and manage hypotensive events in operating room patients with advanced hemodynamic monitoring.