The company has designed the Viz HCM algorithm to help detect more patients with suspected HCM earlier using AI and triaged for diagnosis and further examination
An electrocardiogram report of HCM. (Credit: W.G. de Voogt, MD, PhD, SLAZ, The Netherlands/Wikimedia Commons)
US-based Viz.ai has announced that the US Food and Drug Administration (FDA) has granted a De Novo approval for its artificial intelligence (AI)-based Viz hypertrophic cardiomyopathy (HCM) module.
The Viz HCM algorithm, which is integrated into the Viz.ai platform, is intended for earlier detection and management of HCM.
The disease detection and intelligent care coordination provider said that the module can help to detect more patients with suspected HCM earlier using AI and triaged for diagnosis and further examination.
Viz HCM automatically evaluates the routine electrocardiograms (ECGs) from across a health system to find probable cases of HCM and notifies cardiologists and care teams via the Viz mobile application.
Viz.ai said that this enables clinicians to easily analyse the patient’s ECG, schedule subsequent echocardiography for diagnosis, and access photos and data using the Viz Echo Viewer.
The HCM module is among the 12 FDA-cleared AI algorithms on the Viz.ai platform, which is said to have been used in more than 1,400 hospitals in the US and Europe.
Viz.ai CEO and co-founder Chris Mansi said: “The addition of Viz HCM to the Viz.ai Platform aims to improve outcomes for patients with HCM by getting them to the right specialist faster.
“We are thrilled with this De Novo approval, which establishes the new FDA category of cardiovascular machine learning-based notification software. 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 detection and care of patients with this common, inherited heart disease.”
According to Viz.ai, a multi-year partnership with Bristol Myers Squibb, which was disclosed in March 2023, provides financial backing to deploy the algorithm.
Earlier this year, the health technology company obtained FDA approval for its Viz AAA algorithm to detect suspected abdominal aortic aneurysm (AAA).