FDA Clears AI-Based Coronary Blood Flow Imaging Technology

The US Food and Drug Administration (FDA) has given clearance for a new optical coherence tomography (OCT) imaging platform using Ultreon Software to allow physicians to gain an enhanced view of coronary blood flow and blockages.

The approval allows Abbott to move forward with the combination of OCT and artificial intelligence technology aimed giving physicians a better look in order to aid in decision-making for the best pathway for treatment.

Software

The software used in the technology integrates with Abbott’s Dragonfly OpStar imaging catheter and PressureWire X guidewire, which allows physicians to access a broad set of tools to assess coronary blood flow and blockages, while improving treatment planning.

"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 a statement. "Ultreon Software guides stents to be placed with precision. These types of innovative technologies are instrumental in providing the best care for our patients."

The Need for Technology

Abbott released their annual Beyond Intervention study earlier this year, showing that 83.2% of physicians agreed that advances in diagnostic and treatment technologies have resulted in tangible improvements in 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, in a statement. "AI enables Ultreon Software to automatically detect calcium and vessel diameters allowing doctors to put stents exactly where they are needed."