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Home » Abbott earns FDA clearance, CE mark for next-gen coronary imaging platform

Abbott earns FDA clearance, CE mark for next-gen coronary imaging platform

April 28, 2026 By Sean Whooley

Abbott Ultreon 3.0 software
The Ultreon 3.0 software [Image courtesy of Abbott]
Abbott (NYSE:ABT) announced today that it received FDA clearance and CE mark for its next-generation Ultreon 3.0 software.

Ultreon 3.0 is an AI-powered imaging platform that uses optical coherence tomography (OCT). It combines the technologies in one system to better support patient outcomes and reduce risks in coronary imaging.

The combination of technologies gives doctors real-time planning guidance while they perform percutaneous coronary interventions (PCIs). It allows physicians to use OCT images to see the detailed structure of the blockage. By incorporating AI, they can assess the type of plaque causing the blockage. Altogether, this helps doctors choose the best location and stent size to improve blood flow, delivering faster, more precise procedures.

Ultreon 3.0 builds on previous generations of the software, delivering a one-second OCT pullback. This high-speed, infrared light-based imaging technique captures detailed cross-sectional views of the coronary artery. The technology offers higher resolution readings than intravascular ultrasound (IVUS) with low or zero contrast.

Other key features include a post-procedure assessment for ensuring improved bloodflow, along with a streamlined setup and enhanced AI-automated insights to simplify workflows. Easily acquired images help efficiently plan procedures specifically tailored for patients with complex coronary disease.

Read more about Ultreon technology at Medical Design & Outsourcing.

Commentary from Abbott officials and doctors using Ultreon 3.0

Dr. Ethan Korngold, chief medical officer of Abbott’s Vascular business, said:

“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. 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.”

Dr. Evan Shlofmitz, interventional cardiologist and director of interventional cardiology, St. Francis Hospital and Health Center (Roslyn, New York), said:

“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. By delivering greater clarity, speed, and clinical insight, Ultreon 3.0 accelerates the path to more confident clinician decision making and transformative patient care.”

Dr. David M. Leistner, interventional cardiologist, Clinic for Cardiology and Angiology, Charité Campus Benjamin-Franklin (CBF) in Berlin, Germany, said:

“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.”

Filed Under: 510(k), Artificial Intelligence (AI), Cardiovascular, Featured, Food & Drug Administration (FDA), Health Technology, Imaging, Machine Learning (ML), Regulatory/Compliance, Software / IT, Vascular Tagged With: Abbott, FDA

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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