Abbott’s Ultreon OCT Imaging Software Receives FDA Clearance

August 3, 2021—Abbott announced it has received FDA clearance for an optical coherence tomography (OCT) imaging platform powered by the company’s new Ultreon imaging software. Ultreon combines OCT with artificial intelligence (AI) to provide physicians an enhanced, comprehensive view of coronary blood flow and blockages to assist physician decision-making and provide the best pathway for treatment.

The company noted that clearance in the United States comes after the recently attained CE Mark approval in Europe, providing broader access to the latest OCT imaging platform for interventional cardiologists seeking to utilize the latest in AI-powered technology.

Abbott showcased Ultreon software for the first time at EuroPCR 2021 and recently received approval in Japan.

According to the company, Ultreon software integrates with Abbott’s new Dragonfly OpStar imaging catheter and PressureWire X guidewire to provide physicians access to a broad set of tools to assess coronary blood flow and blockages and improve treatment planning for patients.

“Abbott’s new Ultreon software for OCT provides an automated, comprehensive view of the artery that facilitates physician decision-making,” commented Ziad Ali, MD, Director of the DeMatteis Cardiovascular Institute at St. Francis Hospital and Heart Center in Roslyn, 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.”