Keya Medical said that its DeepVessel artificial intelligence (AI)-based software for fractional flow reserve (FFR)-CT analysis is now available for clinical use in the U.S.
Intended to support the functional evaluation of coronary artery disease, DeepVessel uses deep-learning technology to assess coronary arteries during coronary CT angiography (CCTA) exams, according to the vendor. The software processes CCTA images semi-automatically, generates a 3D model of the coronary artery tree, and estimates FFR-CT values.
DeepVessel was validated in an international multicenter study that included ten clinical sites in the U.S. and the European Union. The clinical trial was led by Dr. Joseph Schoepf of the Medical University of South Carolina.
Recent clearance by the U.S. Food and Drug Administration for DeepVessel follows earlier clearances in Europe and China, the company noted.