Dyad Medicals Cardiac Image Analysis Platform Receives FDA Approval

Dyad Medicals Cardiac Image Analysis Platform Receives FDA Approval

Healthcare Tech Outlook | Tuesday, February 15, 2022

Intravascular Optical Coherence is made possible by Libby™ IAAA's ground-breaking AI and cloud-based technology

FREMONT, CA: “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," states Dr. Ronny Shalev, CEO, and Co-Founder of Dyad Medical. Dyad Medical, developer of the cloud-based artificial intelligence (AI) platform Libby™ for cardiac image analysis, confirms the United States Food and Drug Administration (FDA) has cleared Libby™ IAAA via the 510(k) process. Libby™ IAAA enables intravascular optical coherence tomography (IVOCT) images to view and quantify. The clearance adds another critical tool to healthcare providers' arsenal for automating intravascular inquiry or the ability to view inside blood vessels.

“This new milestone indicates the FDAs trust in Dyad Medicals work and enables broader adoption of imaging AI as an integral part of value-based care,” adds Dr. Shalev.

Coronary artery disease, the most prevalent form of heart disease, is the primary cause of mortality, disability, and rising healthcare expenses globally—it is frequently treated with the insertion of metal stents into the heart's arteries. Stents assist in keeping the artery open by removing impediments and blockages that inhibit coronary blood flow. While drug-eluting stents help prevent restenosis or subsequent blockages, existing therapeutic methods can be improved. Preclinical and clinical tests are required to optimize stent design that is sensitive in vivo or within the heart. IVOCT is the only imaging technique capable of achieving this level of resolution and contrast.

“Stent failure has been linked to inadequate stent expansion, incomplete stent coverage of diseased segments, and untreated dissections at the stent edges,” concludes Dr. Shalev. “By combining AI and technology innovations, LibbyTM IAAA is able to facilitate thorough stent analysis that will help physicians and researchers make accurate observations and conclusions about overall patient health.”

IVOCT imaging has not been widely embraced till recently. Libby™ IAAA is a software application that automates the analysis and interpretation of cardiac images. It needs operators to manually evaluate and analyze cardiac pictures while simultaneously acquiring a vast amount of data during a percutaneous coronary intervention, a minimally invasive treatment intended to clear congested coronary arteries.

A prestigious research hospital has already committed to utilizing Libby™ IAAA. Dyad Medical participates in QualComms' XR Enterprise Program, NVIDIA's Inception Program, and MassChallenge's Boston Accelerator Program.

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