CIVCO gets 510(k) for robotic system

Ultrasound and radiotherapy products developer CIVCO Medical Solutions has received regulatory clearance for an integration of its Protura robotic patient positioning system.

The firm received U.S. Food and Drug Administration (FDA) 510(k) clearance for the integration of Protura with the Motion Management Interface (MMI) from radiation therapy firm Varian Medical Systems.

Protura remotely repositions patients to ensure submillimeter positioning accuracy, according to CIVCO. Integration with Varian's Motion Management Interface automatically opens patient information in Protura software, drawing it from Varian's 4DTC system; automatically loads patient shift data to match Varian's On-Board Imager (OBI) kV imaging system; and automatically imports the Varian pedestal location.

The first clinical use of the Protura and Varian integration was at the Università Cattolica del Sacro Cuore (UCSC) in Rome. During the past year, the UCSC clinic evaluated the effect of the Protura system in a high-volume radiotherapy center, surveying geometrical, dosimetric, management, and clinical parameters.

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