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 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 co-founder 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 buildup in the walls of the arteries that supply blood to the heart and other parts of the body. Coronary artery disease is frequently treated using a metal stent inserted into the heart’s arteries. The stent holds an artery open and breaks up obstructions and blockages that may impede flow to the coronary arteries, and it requires assessments during preclinical and clinical evaluations.
Gold standard IVOCT imaging requires operators to manually interpret and analyze cardiac images while taking in large amounts of data during percutaneous coronary intervention. Libby IAAA automates cardiac image analysis and interpretation to improve coronary artery disease treatment.
“Stent failure has been linked to inadequate stent expansion, incomplete stent coverage of diseased segments, and untreated dissections at the stent edges,” Shalev said. “By combining AI and technology innovations, Libby IAAA is able to facilitate thorough stent analysis that will help physicians and researchers make accurate observations and conclusions about overall patient health.”