Abbott's Ultreon Software Receives FDA Clearance


With FDA clearance announced in a statement on August 3, the Ultreon Software, which combines OCT imaging with artificial intelligence, could help improve diagnosis and treatment compared to traditional imaging methods.

FDA logo with blue backdrop

The US Food and Drug Administration has granted clearance to Abbott’s Ultreon Software, which combines OCT imaging with artificial intelligence to provide a more comprehensive view of coronary blood flow and blockages, according to a press release from Abbott.

Announced on Aug. 3, FDA clearance of the platform comes on the heels of the software attaining a CE Mark in Europe and approval in Japan.

"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," said Nick West, MD, chief medical officer and divisional vice president of global medical affairs at Abbott's vascular business. "AI enables Ultreon Software to automatically detect calcium and vessel diameters allowing doctors to put stents exactly where they are needed."

First showcased at EuroPCR 2021, the first-of-its-kind imaging software works in conjunction with Abbott’s Dragonfly OpStar imaging catheter and PressureWire X Guidewire, which Abbott claims will help provide clinicians with access to a greater array of tools for assessing blood flow and design treatment plans for patients. In their release announcing FDA clearance of Ultreon Software, Abbott pointed out the need for improved imaging technologies to help improve clinical decision-making, citing a recent survey that found 83.2% of clinicians agreed advances in diagnostic and treatment technologies have translated to tangible improvements in patient care.

"Abbott's new Ultreon Software for OCT provides an automated, comprehensive view of the artery that facilitates physician decision-making," said Ziad Ali, MD, DPhil, director of the DeMatteis Cardiovascular Institute at St. Francis Hospital and Heart Center in New York. "Ultreon Software guides stents to be placed with precision. These types of innovative technologies are instrumental in providing the best care for our patients."

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