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.

“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,” David M. Leistner, Interventional Cardiologist at Charité Campus Benjamin-Franklin, said in the announcement.

The platform also provides post-procedure assessment to evaluate whether the stent has improved blood flow, along with a streamlined setup intended to simplify physician workflows.

Systems that combine imaging with AI-based interpretation are being integrated directly into clinical workflows across healthcare settings, particularly in radiology and interventional procedures.

Similar deployments are emerging in imaging networks, where AI is embedded into operational systems to improve speed and consistency of scans and analysis.

High-Volume Procedure and Market Context

PCI remains a widely performed procedure, with more than 600,000 cases annually in the United States and over 885,000 in Europe, according to Abbott. The procedure is used to treat coronary artery disease by placing stents to restore blood flow in narrowed or blocked arteries.

Imaging technologies such as OCT and intravascular ultrasound (IVUS) are used to guide these interventions. OCT provides higher resolution images, allowing physicians to better visualize plaque and vessel structure during treatment.

“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,” Ethan Korngold, Chief Medical Officer of Abbott’s Vascular business, said.

Abbott said the platform builds on its previous Ultreon 2.0 system, adding enhanced AI capabilities to support more consistent and precise treatment planning.

Across the imaging sector, companies are integrating AI to extract more clinical insight from scan data and support decision-making during procedures.