FDA Clears Abbotts AI-Powered Coronary Imaging Platform

The US Food and Drug Administration has cleared Abbott’s latest optical coherence tomography (OCT) imaging platform powered by its new Ultreon Software, the company has announced.

The system is designed to provide a more comprehensive, automated view of coronary blood vessels and potential blockages by combining OCT with artificial intelligence (AI) detection.

A recent study by the company showed that physicians changed their treatment strategy in 88% of coronary artery blockages based on added information from OCT vs angiography alone. 

“As cardiologists continue to adopt OCT and move away from traditional imaging methods such as angiography, emerging technologies are pivotal to determine the best course of patient care,” Nick West, MD, Abbott’s vascular chief medical officer, said in the statement. “AI enables Ultreon Software to automatically detect calcium and vessel diameters allowing doctors to put stents exactly where they are needed.” 

The system received CE mark designation in April 2021.

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