India Pharma Outlook Team | Friday, 01 May 2026
Abbott has announced a major leap in AI coronary imaging with regulatory clearances for its new Ultreon 3.0 platform.
The system has received approval from the U.S. Food and Drug Administration and the CE Mark, signaling readiness for use in both the U.S. and Europe.
This next-generation software brings imaging and artificial intelligence together to improve outcomes in heart procedures.
Ultreon 3.0 uses optical coherence tomography (OCT) to guide doctors in real time during percutaneous coronary intervention (PCI), a minimally invasive procedure to open blocked arteries.
The AI coronary imaging platform analyzes detailed images of plaque buildup, helping physicians determine the right stent size and placement to restore blood flow more effectively.
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"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 software features a one-second OCT pullback, delivering high-resolution images faster than traditional methods and using little to no contrast dye—an advantage for patients with kidney disease. It also supports pre- and post-procedure assessment, giving doctors a full picture before and after stent placement.
"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," said David M. Leistner, interventional cardiologist, Clinic for Cardiology and Angiology, Charité Campus Benjamin-Franklin (CBF) in Berlin, Germany.
Built on its earlier version, the platform enhances workflow, simplifies setup, and improves precision in complex PCI cases, which affect hundreds of thousands of patients each year.