Therapy Areas: Devices
Body Vision Medical wins US FDA clearance for LungVision 2.0 System for accurate access in pulmonary nodules
20 May 2019 -

Medical device company Body Vision Medical reported on Friday the receipt of US Food and Drug Administration market clearance for the LungVision 2.0 System that allows real-time tool-in-lesion confirmation through C-Arm Based Tomography (CABT) to provide an accurate access to pulmonary nodules.

The company said the updated LungVision System, part of LungVision Platform, features real-time tool-in-lesion confirmation combined with seamless integration of LungVision Tool, a disposable lung navigation catheter with superb maneuverability. The combination allows access of any endotherapy accessories to small pulmonary nodules.

This US FDA approval is based on the outstanding results from the company's multicentre clinical trials in over 400 clinical procedures in the US. LungVision allows physicians to plan, visualise and track endobronchial tools inside the radiolucent lesions in real time. It instantly fuses intraoperative imaging with pre-operative CT.

From 19-21 May, the company will exhibit its LungVision 2.0 platform at the ATS Annual Meeting 2019 held in Dallas as well as feature two presentations of LungVision.

Krish Bhadra, MD, CHI Memorial Hospital, will present the strengths of artificial intelligence in navigational bronchoscopy. Daniel Nader, MD, Cancer Treatment Centers of America, will present the contribution of the LungVision Platform in fiducial marker placement to increase efficiency of SBRT radio surgery.