Abbott gains FDA clearance, CE mark approval for AI-powered imaging platform
Abbott has received U.S. Food and Drug Administration (FDA) clearance and CE mark approval for Ultreon 3.0, its next-generation coronary imaging platform.
Ultreon 3.0, an update of the company’s Ultreon 2.0 technology, uses advanced artificial intelligence (AI) algorithms to capture and evaluate optical coherence tomography (OCT) images, delivering real-time guidance during percutaneous coronary intervention (PCI) procedures. OCT is a critical modality for the diagnosis, treatment and management of coronary disease. This platform was built to give clinicians detailed OCT images from inside the blood vessels. It then uses those images to assess the blockage being treated and make recommendations to the PCI operator on the selection and placement any stents.
“Ultreon 3.0 represents a pivotal step forward in how we treat and ultimately care for our patients,” Evan Shlofmitz, DO, director of interventional cardiology at St. Francis Hospital and Health Center in Roslyn, New York, said in a statement. “This next-generation platform, combining imaging and AI, doesn't just improve upon existing technology—it leapfrogs it. By delivering greater clarity, speed, and clinical insight, Ultreon 3.0 accelerates the path to more confident clinician decision making and transformative patient care.”
“Complemented by our leading coronary portfolio, Ultreon 3.0 makes OCT imaging more intuitive and powerful for physicians, reimagining imaging into a tool for precision-guided intervention before and after procedures,” added Ethan Korngold, MD, chief medical officer of Abbott's vascular business. “Advancements like Ultreon 3.0 showcase Abbott's leadership in AI-powered imaging and as a trusted partner in delivering smarter, more personalized coronary care.”
FDA clearance means Abbott can now market and sell Ultreon 3.0 throughout the United States. CE mark approval, meanwhile, means the technology can be sold throughout the EU.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.