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March 3, 2023

Viz.ai Collaborates With Bristol Myers Squibb to Deploy Viz HCM Software

March 3, 2023—Viz.ai announced a multiyear agreement with Bristol Myers Squibb to deploy Viz HCM, an artificial intelligence (AI) algorithm and provider workflow software intended to identify and triage patients who may require further evaluation for the detection of hypertrophic cardiomyopathy (HCM).

Viz.ai has submitted a de novo request to the FDA for the algorithm as a Software-as-a-Medical-Device (SaMD). The SaMD filing has been accepted by the agency for review.

According to the company, Viz HCM is intended to automatically review routine electrocardiograms (ECGs) from across a health system, identify suspected cases of HCM, and notify the appropriate cardiologist. The physician can then review the ECG in a timely manner and take the appropriate clinical action, including recommending follow-up diagnostic testing in parallel to the standard of care.

David Huneycutt, MD, a cardiologist at HCA Healthcare’s TriStar Centennial Medical Center in Nashville, Tennessee, and an enterprise-wide cardiovascular physician director, commented in Viz.ai’s press release, “HCM is the most common inherited heart disease with an estimated prevalence between 1 in 200 and 1 in 500 and one of the leading causes of sudden cardiac death in people under age 35. Since a high percentage of patients remain undiagnosed, it is critical that we find solutions to identify patients with suspected HCM sooner.”

The company stated that Viz HCM will be integrated into the Viz.ai Cardio Suite for United States hospitals, which is expected to advance cardiac care coordination through a mobile-based ECG viewer, built with timely AI-powered alerts and communication tools.

The Viz.ai Intelligent Care Coordination Platform, which includes Viz.ai Cardio Suite, is adopted by approximately 1,300 hospitals in the United States. Viz.ai has placed Viz HCM at several hospitals, including select HCA Healthcare facilities, under research agreements to further evaluate the product in clinical practice. The company plans to launch Viz HCM broadly upon FDA clearance.

Suhas Krishna, Vice President, Head of Digital Health Product Management, Bristol Myers Squibb, stated in the Viz.ai press release, “At Bristol Myers Squibb, we believe that the use of AI to detect key, subtle characteristics in biosignals to aid physicians in the screening, diagnosis, treatment, and monitoring of diseases will have a critical and positive impact on patients’ lives. We are excited to continue building momentum in our support of Viz.ai’s research and development program. The speed and quality in which this novel AI algorithm and workflow sequencing product was designed, verified, validated, and submitted by Viz.ai for agency review is testament to the ability to drive rapid and meaningful innovation in health care.”

Viz.ai's CEO Chris Mansi, MD, commented in the press release, “HCM can be a devastating disease. The agreement with Bristol Myers Squibb gives us the opportunity to enable underdiagnosed and underserved HCM patients to get the care they need from appropriate providers at the right time. Incorporating the new HCM module into the Viz Cardio Suite is expected to enhance detection, expedite care, and empower clinicians and patients.”

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