FDA Clears Optical Coherence Tomography System for AI-Enabled High-Resolution Imaging of Coronary Plaque

The Food and Drug Administration (FDA) has granted 510(k) clearance for the Ultreon 3.0 optical coherence tomography (OCT) system, which may help bolster outcomes with percutaneous coronary intervention (PCI) procedures.

Abbott, the developer of the Ultreon 3.0 platform, said the next-generation OCT system offers enhanced real-time visualization of blocked heart arteries as well as AI insights on plaque assessment and stent sizing.

The company emphasized that the Ultreon 3.0 system offers a rapid infrared light-based imaging technique that can capture enhanced cross-sectional views of the coronary artery with low or zero contrast. This may be a significant benefit of the Ultreon 3.0 platform as patients with kidney disease represent approximately 25 percent of people with coronary artery disease (CAD), according to Abbott.

“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, DO, the director of interventional cardiology at St. Francis Hospital and Health Center in Roslyn, N.Y. "By delivering greater clarity, speed, and clinical insight, Ultreon 3.0 accelerates the path to more confident clinician decision making and transformative patient care."