Abbott Gets 510(k) Clearance for Optical Coherence Tomography Imaging Platform

August 6, 2021

Abbott has received 510(k) clearance from the FDA for a new optical coherence tomography (OCT) imaging platform that uses the company's Ultreon software.

The software combines tomography with artificial intelligence to help physicians assess coronary blood flow and blockages, and to choose the best pathway for treatment.

The Ultreon software works with Abbott's Dragonfly OpStar imaging catheter and PressureWire X guidewire. The new OCT imaging platform also recently received a CE mark certification.

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