Abbott announced on April 28, 2026, that it received U.S. FDA clearance and CE Mark for Ultreon 3.0 software.123
Ultreon 3.0 is an AI-powered platform using optical coherence tomography (OCT) for real-time guidance in percutaneous coronary intervention (PCI) to treat blocked arteries.23
It provides high-resolution imaging, AI-automated insights for plaque assessment, stent sizing, and placement, with a one-second OCT pullback using low or zero contrast.23
The technology offers higher resolution than intravascular ultrasound (IVUS), benefits patients with kidney disease, and streamlines workflows for complex coronary cases.23
Built on Ultreon 2.0, it integrates imaging and AI for faster, precise procedures and better patient outcomes.23
Sources:
1. https://marketchameleon.com/articles/b/2026/4/28/abbott-fda-clearance-ultreon-ai-coronary-imaging-platform
2. https://www.prnewswire.com/news-releases/abbott-receives-fda-clearance-and-ce-mark-for-next-generation-ultreon-3-0-ai-powered-coronary-imaging-platform-302755466.html
3. https://www.itnonline.com/content/abbott-receives-fda-clearance-ce-mark-next-gen%C2%A0ai-powered-coronary-imaging-platform