India Pharma Outlook Team | Thursday, 30 April 2026
Abbott announced it has secured U.S. Food and Drug Administration clearance and CE Mark approval for its latest OCT imaging system, Ultreon 3.0, signaling a major move in complex coronary care.
The platform combines high-resolution imaging with artificial intelligence to support doctors during procedures and improve patient outcomes.
The OCT imaging system uses optical coherence tomography to deliver real-time guidance during percutaneous coronary intervention (PCI), a minimally invasive procedure used to open blocked heart arteries.
By capturing detailed cross-sectional images, the system helps physicians understand the structure and severity of blockages and identify the type of plaque involved, allowing for better stent selection and placement.
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"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.
A key feature of the system is its one-second OCT pullback, which rapidly gathers high-quality images while reducing the need for contrast dye. This is especially useful for patients with kidney disease, who make up about a quarter of those with coronary artery disease. The platform also offers AI-powered insights, streamlined workflow, and post-procedure checks to confirm improved blood flow.
"Abbott's 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," said David M. Leistner.
Built for complex PCI cases, Ultreon 3.0 enhances precision and speed, helping physicians handle challenging artery blockages more effectively. With over 600,000 procedures in the U.S. and 885,000 in Europe each year, Abbott aims to deliver more consistent and personalized cardiac care through this next-generation system.