Dyad Medical Gains 510(k) Clearance for Its Libby Cardiac Image Analyzer

Dyad Medical’s Libby IAAA cloud-based artificial intelligence (AI) software product for analysis of cardiac images has received the FDA’s 510(k) clearance.

The software, which analyzes intravascular optical coherence tomography (IVOCT) images of the heart, can be used to optimize drug-eluting stents used to treat coronary artery disease.

IVOCT imaging has not yet been widely adopted because it requires operators to manually interpret and analyze cardiac images during minimally invasive procedures used to open clogged coronary arteries. The Libby IAAA analyzer can be used to automate the process of image analysis and interpretation, the company said