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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