The partnership seeks to deploy an AI algorithm and the Viz HCM provider workflow software. This can help identify and triage patients who may require further evaluation for the detection of hypertrophic cardiomyopathy.
San Francisco-based Viz.ai submitted a de novo request to the FDA for the algorithm as a software-as-a-medical device (SaMD). The agency accepted the filing for review, according to a news release.
Hypertrophic cardiomyopathy (HCM) occurs when heart muscle thickens, making it harder for the heart to pump blood. It can lead to increased risks of AFib, mitral valve disease and heart failure.
Suhas Krishna, Bristol Myers Squibb VP and head of digital health product management, said the company believes AI can positively impact patients’ lives by detecting key, subtle characteristics in biosignals. It could aid physicians in screening, diagnosis, treatment and monitoring of diseases, Krishna added.
“We are excited to continue building momentum in our support of Viz.ai’s research and development program,” Krishna said. “The speed and quality in which this novel AI algorithm & workflow sequencing product was designed, verified, validated, and submitted by Viz.ai for agency review is a testament to the ability to drive rapid and meaningful innovation in healthcare.”
More about Viz HCM
Viz HCM automatically reviews ECGs from across a health system. It helps to identify suspected HCM cases and notify the appropriate cardiologist, who can then review the ECG in a timely manner.
Viz.ai plans to integrate this platform into its Viz.ai Cardio Suite for U.S. hospitals. The suite offers a mobile-based ECG viewer with timely AI-powered alerts and communication tools. Once Viz HCM receives FDA clearance, the company plans to launch it “broadly.”
“Hypertrophic cardiomyopathy 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,” said Dr. Chris Mansi, CEO at Viz.ai. “Incorporating the new HCM module into the Viz Cardio Suite is expected to enhance detection, expedite care, and empower clinicians and patients.”