Dyad Medical today announced it received FDA 510(k) clearance for its echocardiogram application Echo:Prio.
The Boston-based company’s Echo:Prio is part of its complete cardiac platform named Libby. The whole system analyzes images from echocardiograms.
Echocardiograms are important in diagnosing heart disease and developing a treatment plan. The process requires a complete view of the endocardium, but image interpretations can be influenced by operator skill level and variations in heart rates and cardiac loading. Automated analysis can address those challenges.
“The current process of manual echocardiographic assessment of myocardial function is time-consuming and lacks consistency between readings. 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,” CEO and cofounder Dr. Ronny Shalev said in a news release.
Libby Echo:Prio has a workflow of imaging operators, physicians and researchers. It is a cloud-based program that uses a secure connection from any location on any device. Echo:Prio is also AI-powered and gives an immediate second opinion when diagnosing cardiac images.
“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,” said Shalev. “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.”
This is the second FDA clearance for the company. Dyad Medical won 510(k) clearance for the Libby IAAA cardiac image analysis platform in February. The IAAA is used for viewing and quantifying intravascular optical coherence tomography images.