Dyad Medical wins FDA clearance for cardiac imaging platform Echo:Prio

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, r…

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FDA clears Dyad Medical automated cardiac image analysis platform

Dyad Medical this week announced that it received FDA 510(k) clearance for its Libby IAAA cardiac image analysis platform.

Boston-based Dyad Medical designed the Libby IAAA for image analysis used for viewing and quantifying intravascular optical coherence tomography (IVOCT) images. It allows healthcare professionals to automate intravascular investigation and the ability to see inside of blood vessels to improve treatment for coronary artery disease.

“Dyad Medical is proud to offer hospital systems, imaging centers, and researchers a tool to conduct cardiac image analysis in a fraction of the time,” CEO and cofounder Ronny Shalev said in a news release. “This new milestone indicates the FDA’s trust in Dyad Medical’s work and enables broader adoption of imaging AI as an integral part of value-based care.”

Coronary artery disease is the most common type of heart disease, according to the Centers for Disease Control and Prevention. It is caused by plaque b…

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