FDA clears integrated IVUS capabilities on GE Innova

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GE Healthcare and Volcano Corporation announced today FDA 510(k) clearance for the integration of Volcano’s intravascular ultrasound imaging (IVUS) capabilities onto GE’s Innova all-digital x-ray cath lab imaging system. This digital cardiovascular imaging system is designed to give interventional cardiologists and interventional radiologists a clearer view of coronary and peripheral vessel morphology in a more accessible manner than previously available, the companies said.

The integrated product will be commercialized as “Innova IVUS,” and has resulted from an agreement entered into by GE Healthcare and Volcano in March. Volcano’s latest PC-based IVUS platform reduces the size, weight and noise of the IVUS console, allowing the unit to be located in the control room or in other areas outside of the daily traffic pattern of the cath lab. The integrated user interface is designed to optimize workflow when performing IVUS, and to speed up processes.