Abbott Wins FDA, EU Nods for Ultreon 3.0 AI-Powered Coronary Imaging

Abbott revealed that it has obtained U.S. Food and Drug Administration (FDA) and CE mark clearances for its next-gen Ultreon 3.0 software.

Ultreon 3.0 is an artificial intelligence (AI)-powered imaging platform that uses optical coherence tomography (OCT) that provides doctors real-time planning guidance while they perform minimally invasive procedures to open blocked heart arteries, known as percutaneous coronary intervention (PCI).

The technology lets physicians use OCT images to view the blockage’s detailed structure. It incorporates AI to assess the type of plaque causing the blockage so the clinician can choose the best location and size of the stent to improve blood flow.

“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, director of interventional cardiology, 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.”

The next-gen software features a one-second OCT pullback, a high-speed infrared light-based imaging technique that quickly captures detailed cross-sectional views of the coronary artery. Abbott said this offers higher resolution readings than intravascular ultrasound (IVUS), with low or zero contrast.

Ultreon 3.0 also includes a post-procedure assessment to ensure the stent improved blood flow in the artery.

“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,” said Ethan Korngold, MD, chief medical officer at 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.”