Abbott’s Ultreon 3.0 AI Coronary Imaging Platform Receives FDA Clearance, CE Mark Approval

May 1, 2026—Abbott announced it received FDA clearance and CE Mark approval for its next-generation Ultreon 3.0 software, an artificial intelligence (AI)–powered imaging platform that uses optical coherence tomography (OCT) to provide real-time planning guidance during percutaneous coronary intervention (PCI) procedures.

The OCT images show the detailed structure of the blockage, while AI is used to assess the type of plaque causing the blockage. The goal is to help the interventionalist choose the best location and size of the stent to improve blood flow, stated Abbott.

The company further noted that the next-generation software features a 1-second OCT pullback. The high-speed, infrared light–based imaging technique quickly captures detailed cross-sectional views of the coronary artery, offering higher resolution readings than intravascular ultrasound and with low or zero contrast.

“Ultreon 3.0 represents a pivotal step forward in how we treat and ultimately care for our patients,” commented Evan Shlofmitz, DO, in Abbott’s press release. “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.”

David M. Leistner, MD, 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. Every second and every decision matters when treating patients who have blockages in their coronary arteries, and Ultreon 3.0 enables faster, more informed clinical choices that can have a real impact on patients.”