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FDA Approves AI-powered OCT Health IT for Clinical Decision Support

The FDA has granted health IT vendor Abbott clearance on its new AI-based OCT imaging software for enhanced cardiology clinical decision support.

FDA Approves AI-powered OCT Health IT for Clinical Decision Support

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By Hannah Nelson

- The Food and Drug Administration (FDA) has approved health IT vendor Abbott’s latest optical coherence tomography (OCT) imaging software that uses artificial intelligence (AI) to enhance clinical decision support for cardiologists.

The imaging platform, powered by the company's new Ultreon Software, combines OCT with AI to provide physicians a comprehensive view of coronary blood flow and blockages.

Ultreon Software integrates with the health IT vendor’s new Dragonfly OpStar imaging catheter and PressureWire X guidewire, giving physicians access to a wide set of tools to guide clinical decision support.

"Abbott's new Ultreon Software for OCT provides an automated, comprehensive view of the artery that facilitates physician decision-making," Ziad Ali, MD, DPhil, director of the DeMatteis Cardiovascular Institute at St. Francis Hospital and Heart Center, said in a public statement.

"Ultreon Software guides stents to be placed with precision,” Ali continued. “These types of innovative technologies are instrumental in providing the best care for our patients.”

An Abbott study from earlier this year found that physicians view innovative technologies as critical components to high quality care delivery. Over 80 percent of physicians agreed that advances in diagnostic and treatment technologies, like OCT, have improved patient care.

"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,” West explained.

US clearance follows the software’s recently attained CE Mark in Europe.