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StocksUpdated•Originally published 28 April 2026•Updated 28 April 2026•

1 min read

Abbott Secures FDA Clearance and CE Mark for Ultreon 3.0 AI Imaging Platform

Key Facts

1Abbott received U.S. FDA clearance and CE Mark for its next-generation Ultreon 3.0 Software for coronary imaging.

2The platform is the first OCT system in the U.S. and Europe to integrate coronary plaque images with AI-automated insights.

Abbott has secured U.S. FDA clearance and the European CE Mark for its Ultreon 3.0 software, the first OCT system to integrate AI-automated insights for coronary imaging in these markets. The updated platform features a one-second OCT pullback for rapid artery scanning, significantly accelerating clinical workflows for medical teams. Additionally, this new technology assists in reducing the requirement for contrast agents during percutaneous coronary intervention (PCI) procedures, enhancing patient safety. By utilizing artificial intelligence, the software provides real-time data to help physicians accurately size and position stents. This dual regulatory approval marks a major milestone in Abbott's R&D cycle and strengthens its position in the global healthcare sector. These advancements are expected to improve clinical outcomes for patients with complex coronary artery disease.

about 1 month ago

Version History

Version 1about 1 month ago

What changed: Updated to include new technical specifications, including the one-second scan capability and the benefit of reduced contrast agent usage.