Abbott Secures FDA Breakthrough Status for AI-Powered Ultreon™ 3.0 Coronary Imaging Platform

Abbott has secured both FDA clearance in the United States and CE Mark certification for Ultreon™ 3.0, its latest artificial intelligence-enabled platform for coronary imaging.

The software combines optical coherence tomography imaging with artificial intelligence to support physicians during percutaneous coronary intervention, a minimally invasive procedure used to treat blocked coronary arteries.

Ultreon 3.0 provides real-time insights that help clinicians assess plaque characteristics, understand the size and location of blockages, and determine optimal stent placement.

The platform features a one-second OCT pullback, delivering high-resolution images of coronary arteries with low or no contrast use, which may be beneficial for patients with kidney disease.

The software also offers AI-driven treatment planning, streamlined workflow integration, and post-procedure assessments to confirm improved blood flow after stent implantation.

Designed for use in complex PCI cases, Ultreon 3.0 aims to improve procedural efficiency, clinical precision, and decision-making.

Building on the capabilities of Ultreon 2.0, the latest platform strengthens Abbott’s portfolio of AI-enabled cardiovascular technologies and supports more personalised care for patients with coronary artery disease.