Viz.ai announced today that the FDA granted de novo approval to its Viz HCM module for detecting hypertrophic cardiomyopathy.
San Francisco-based Viz.ai says this creates a new regulatory category for cardiovascular machine learning-based notification software. The company supports its algorithm’s deployment through a multi-year agreement with Bristol Myers Squibb. They struck that partnership deal in March of this year.
With Viz HCM — integrated into the Viz.ai platform — providers can identify more patients with suspected HCM earlier using AI. They can then receive triage and diagnosis for further evaluation.
The Viz HCM module automatically reviews routine electrocardiograms (ECGs) from across a health system. It identifies suspected HCM cases and notifies the appropriate cardiologists and care team on the Viz mobile application. Clinicians can then easily review the patient’s ECG and coordinate follow-up for diagnosis. They can then use t…