Abbott announced on April 28 that it has received clearance from the U.S. Food and Drug Administration and a CE Mark for its new Ultreon 3.0 Software, an artificial intelligence-powered coronary imaging platform.
The approval of Ultreon 3.0 marks a significant development in the treatment of complex coronary disease, as it brings together advanced optical coherence tomography (OCT) imaging and AI-automated insights to support improved patient outcomes.
Ultreon 3.0 is designed to assist physicians during minimally invasive procedures to open blocked heart arteries by providing real-time planning guidance using OCT images and AI-driven analysis of plaque types. This integration allows doctors to make faster, more informed decisions regarding stent placement and sizing during percutaneous coronary intervention procedures.
“Ultreon 3.0 represents a pivotal step forward in how we treat and ultimately care for our patients. This next-generation platform, combining imaging and AI, doesn’t just improve upon existing technology — it leapfrogs it,” said Evan Shlofmitz, D.O., interventional cardiologist at St. Francis Hospital and Health Center in Roslyn, NY. “By delivering greater clarity, speed, and clinical insight, Ultreon 3.0 accelerates the path to more confident clinician decision making and transformative patient care.” David M. Leistner of Charité Campus Benjamin-Franklin in Berlin added: “Abbott’s Ultreon 3.0 offers a single, AI-driven platform that quickly and easily captures the images physicians need to fully understand the size and angle of the blockage, and create an actionable plan to help the patient…Ultreon 3.0 enables faster, more informed clinical choices that can have a real impact on patients.” Ethan Korngold, M.D., chief medical officer at Abbott’s vascular business said: “Complemented by our leading coronary portfolio, Ultreon 3.0 makes OCT imaging more intuitive and powerful for physicians…Advancements like Ultreon 3.0 showcase Abbott’s leadership in AI-powered imaging…”
The software features rapid one-second OCT pullback with high-resolution cross-sectional views using infrared light-based techniques—offering higher resolution than intravascular ultrasound with low or zero contrast use—which may benefit some patients with kidney disease who are especially vulnerable during such procedures.
According to Abbott’s announcement, over 600,000 people undergo percutaneous coronary intervention annually in the United States alone while Europe sees over 885,000 such cases each year; many involve complex lesions requiring multiple stents.
Ultreon 3.0 builds on previous versions by introducing enhanced AI capabilities aimed at improving precision-guided interventions before and after procedures.
