Keya Medical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for DeepVessel Plaque, an AI-powered coronary plaque analysis tool for coronary CT angiography (CCTA).
The cloud-based software uses deep-learning technology to segment coronary arteries, vessel walls, and lumen structures, providing quantitative measurements including total plaque volume, calcified and non-calcified plaque volume, low-density plaque volume, plaque burden, stenosis severity, and CAD-RADS stenosis categorization, the company said. It is indicated for adults with suspected or known coronary artery disease (CAD).
The clearance was supported by a multicenter clinical validation study at three U.S. sites, which demonstrated a Pearson correlation coefficient of 0.976 for total plaque volume and substantial agreement for CAD-RADS stenosis categorization with expert-reader consensus, according to the company.
DeepVessel Plaque joins DeepVessel FFR, Keya Medical's functional CAD assessment tool, in its coronary CTA analysis portfolio.
