Viz HCM
Viz.ai, Inc.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.
Intended Use
Viz HCM is intended to be used in parallel to the standard of care to analyze recordings of 12-lead ECG made on compatible ECG devices to detect signs associated with hypertrophic cardiomyopathy (HCM) in patients 18 years or older.
Technology
The Viz HCM system consists of a machine learning-based ECG analysis algorithm and a mobile application software module. It analyzes 12-lead ECG signals to identify patterns suggestive of hypertrophic cardiomyopathy. The software was developed and validated on a large, ethnically diverse dataset of ECGs, with detailed model input-output descriptions and integration testing. It includes measures to control input signal quality and mitigate user or hardware errors, ensuring output accuracy. Cybersecurity and usability have been assessed according to FDA guidance.
Performance
Performance testing included development, internal validation, usability testing, and clinical performance testing with a retrospective study of 3,196 ECG cases (291 HCM-Positive, 2,905 HCM-Negative). The algorithm achieved 68.4% sensitivity, 99.1% specificity, and 13.7% positive predictive value (PPV) at a prevalence of 0.002. Diverse datasets with demographic and hardware variety supported validation. Usability testing confirmed no use errors and good user understanding. Clinical adjudication involved cardiologist chart and imaging review. Subgroup analyses by gender, age, race, ethnicity, and HCM type were conducted to confirm consistent performance.
Device Timeline
- 1
Submission
1/10/2023
6 months - 2
FDA Approval
8/3/2023
Other devices from Viz.ai, Inc.
- Viz HDS, Viz Volume Plus, Viz ICH+2024 • 510K
- Viz AAA2023 • 510K
- Viz LVO ContaCT2022 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.