Dyad Medical’s Libby IAAA Cardiac Image Analysis Platform Cleared by FDA

February 22, 2022—Dyad Medical, Inc. announced FDA 510(k) clearance of the company’s Libby IAAA cardiac image analysis software, a cloud-based artificial intelligence (AI) technology.

According to the company, Libby IAAA image analysis is used for viewing and quantifying intravascular optical coherence tomography (IVOCT) images. The IVOCT imaging method provides the resolution and contrast to accomplish sensitive in vivo assessments for preclinical and clinical evaluations to optimize stent designs.

Dyad Medical noted that IVOCT imaging has not been widely adopted because it requires operators to manually interpret and analyze cardiac images, taking in a large amount of data in real-time during percutaneous coronary intervention. Now, Libby IAAA provides an automated solution in cardiac image analysis and interpretation.

Ronny Shalev, PhD, who is CEO and Co-Founder of Dyad Medical, commented in the company’s press release, “Stent failure has been linked to inadequate stent expansion, incomplete stent coverage of diseased segments, and untreated dissections at the stent edges. 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.”

Additionally, Dr. Shalev stated, “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. 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.”