Abbott’s latest-generation Ultreon software gains FDA approval, CE mark

Abbott has received US Food and Drug Administration (FDA) clearance and CE marking for its next-generation Ultreon 3.0 software.

Ultreon 3.0 is an artificial intelligence (AI)-powered imaging platform that uses optical coherence tomography (OCT) to give doctors real-time planning guidance while they perform percutaneous coronary intervention (PCI), incorporating AI to assess the type of plaque causing the blockage

“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 (St Francis Hospital and Health Center, Roslyn, USA). “By delivering greater clarity, speed, and clinical insight, Ultreon 3.0 accelerates the path to more confident clinician decision making and transformative patient care.”

“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 (Charité Campus Benjamin-Franklin, Berlin, Germany). “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.”

The next-generation software features a one-second OCT pullback; a post-procedure assessment to ensure the stent improved blood flow in the artery; a streamlined setup and enhanced AI-automated insights; and easily acquired images from inside blood vessels, Abbott says in a press release.


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