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Body Vision gets FDA nod for its navigation catheter

par Lauren Dubinsky, Senior Reporter | May 16, 2018
Endoscopy Medical Devices
May replace electro-magnetic sensing
Body Vision Medical announced on Monday that its LungVision Tool navigation catheter scored FDA clearance.

The tool is used along with conventional bronchoscopes and the company’s LungVision System to guide endotherapy accessories to small pulmonary nodules.

The LungVision Imaging and Navigation System is an augmented reality technology that enables surgeons to plan, visualize and track endobronchial tools and radiolucent lesions in real time. It combines intraoperative fluoroscopy and pre-operative high-resolution imaging such as CT and has already been used for over 290 clinical procedures in 10 lung cancer centers in the U.S.

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It was investigated as part of a clinical multicentral study and the results will be presented at the American Thoracic Society Conference at the end of May in San Diego. The presenters are from Moore Regional Hospital in North Carolina, CHI Memorial Hospital in Tennessee and Rabin Medical Center in New York.

"LungVision navigation tool has clear performance and cost benefits over current navigation tools that are bound to electro-magnetic sensing,” Dr. Krish Bhadra of CHI Memorial Hospital, said in a statement.

Electromagnetic navigation bronchoscopy generates a virtual, 3D bronchial map from chest CT scans. The physicians then use the map to navigate to the target location within the lung.

Dorian Averbuch, the CEO of Body Vision, believes that the clearance of the new tool will pave the way for the LungVision System to become the preferred choice in bronchoscopy for U.S. lung cancer centers.

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