Dyad Medical’s Echo:Prio Cardiac Imaging Analysis Platform Cleared by FDA

August 15, 2022—Dyad Medical, Inc., a developer of the cloud-based artificial intelligence (AI) technology for cardiac image analysis, announced FDA 510(k) clearance of its Echo:Prio application for echocardiograms.

Echo:Prio is part of Libby, the company’s complete cardiac platform that is intended to provide fast, data-driven image analysis of echocardiogram images. It is a decision-making support tool for index quantification of cardiac function to support clinicians’ diagnosis and treatment decision-making.

According to the company, Libby Echo:Prio is embedded in the current workflow of imaging operators, physicians, and researchers. The Libby platform is cloud-based, offering users a secure way to use it from any location on any device. Additionally, the AI-powered platform provides users an immediately available second opinion when diagnosing cardiac images.

“The current process of manual echocardiographic assessment of myocardial function is time-consuming and lacks consistency between readings,” stated Ronny Shalev, PhD, who is CEO and co-founder of Dyad Medical, in the company’s press release. “The FDA’s clearance of Dyad Medical’s Echo:Prio application allows us to provide operators and physicians an essential computer-assisted tool for echocardiographic analysis. Our solution is proven to be consistent and can be used across all systems, regardless of an operator’s skill level.”

Dr. Shalev continued, “Dyad Medical’s Echo:Prio application allows physicians to prioritize patient treatments and deliver the life-saving care needed for those who need it most. Echocardiogram analysis done manually is time-consuming and must be done consistently across all patients and operators. Echo:Prio is expanding the physician’s view, so they have greater confidence in their diagnosis leading to greater patient satisfaction and retention.”

The company previously was granted FDA clearance for its Libby cardiac imaging analysis platform. Additionally, the company’s intravascular optical coherence tomography application has been cleared by the FDA, noted Dyad Medical.