Viz.ai’s hypertrophic cardiomyopathy algorithm gets FDA De Novo approval

Bristol Myers Squibb has provided financial support for the algorithm's implementation.

RanjithKumar Dharma August 16 2023

The US Food and Drug Administration (FDA) has granted De Novo approval for Viz.ai’s hypertrophic cardiomyopathy (HCM) artificial intelligence (AI) detection algorithm, Viz HCM module.

Bristol Myers Squibb provided financial backing for the algorithm's implementation through a multi-year agreement announced in March this year.

By leveraging Viz HCM, which is incorporated into the Viz.ai platform, physicians can identify more individuals with suspected HCM by tapping AI and triaging them for diagnosis and further analysis.

To detect suspected HCM cases and notify cardiologists and care teams through the Viz mobile application, the Viz HCM module automatically reviews routine electrocardiograms (ECGs) from across a health system.

Later, medical professionals can examine the patient's ECG, arrange a follow-up echocardiogram for diagnosis and utilise the Viz Echo Viewer to assess images and obtain echocardiogram reports.

The HCM module stands as one of 12 FDA-approved AI algorithms on the enterprise-wide, clinically validated Viz.ai Platform, according to the company.

The company has also claimed that this platform has demonstrated its capacity to enhance treatment accessibility and boost patient outcomes across over 1,400 hospitals in the US and Europe.

Viz.ai CEO and founder Chris Mansi said: “The ongoing investment of innovative capabilities on our platform is why it continues to be the first choice of leading healthcare systems.

“With our AI-powered Viz HCM module, we look forward to realising its promise in expediting the detection and care of patients with this common, inherited heart disease.”

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