The U.S. Food and Drug Administration (FDA) has approved an artificial intelligence (AI) tool to detect and manage Hypertrophic Cardiomyopathy (HCM).
The electrocardiogram (ECG) analysis software from Viz.ai will help identify for follow-up care potential cases of HCM, a rare condition where the heart muscle becomes thick, making it difficult for the heart to pump.
The FDA approval creates a new regulatory category for cardiovascular machine learning-based notification software, Viz.ai said.
“Given the high prevalence of patients with suspected HCM who remain undiagnosed, flagging and connecting them quickly to the right providers is critical to improve health outcomes,” said Matthew Martinez, MD, director of sports cardiology and HCM, Atlantic Health System. “The role of artificial intelligence in cardiology is growing exponentially and adding the HCM module to Viz.ai will help increase awareness and reach for HCM patients.”
The program reviews routine ECGs across a health system and notifies the care team when it identifies a potential HCM case. The new HCM module is part of 12 FDA-cleared AI algorithms on the Viz.ai platform used at more than 1,400 hospitals in the US and Europe, the company said.
