Abbott Receives FDA Clearance, CE Mark for Ultreon 3.0 AI Imaging Platform

Abbott Laboratories said it received U.S. Food and Drug Administration (FDA) clearance and CE Mark for its Ultreon 3.0 software, an artificial intelligence (AI)-powered coronary imaging platform designed to guide physicians during heart procedures.

The system uses optical coherence tomography (OCT), a high-resolution imaging method, combined with AI to provide real-time insights during percutaneous coronary intervention (PCI), a minimally invasive procedure used to open blocked arteries. It is designed to help physicians assess plaque characteristics, determine stent size, and guide placement inside the artery.

Integrated Imaging and AI for Procedural Guidance

Abbott said Ultreon 3.0 integrates imaging and AI-based analysis into a single workflow, enabling faster and more precise decision-making during complex coronary procedures. The platform captures detailed cross-sectional images of arteries and applies AI to identify the type and structure of blockages.

The software includes a one-second OCT pullback, allowing physicians to capture images quickly during procedures. It also supports low or zero contrast imaging, which may benefit patients with kidney disease, who account for about 25% of those with coronary artery disease.