Body Vision Medical, a medical device company specialized real-time imaging, has secured clearance from the US Food and Drug Administration (FDA) to market its LungVision 2.0 System.
Launched on 1 October 2018, Body Vision Medical’s LungVision System features a real-time tool-in-lesion confirmation combined with integration of LungVision Tool, a disposable lung navigation catheter with maneuverability.
The company said that the LungVision Tool is guided by LungVision 2.0 System and is used through the standard bronchoscopes to allow access of any endotherapy accessories to small pulmonary nodules.
The system takes advantage of machine learning and a sophisticated augmented reality approach for accurate real-time navigation.
In addition, it allows physicians to plan, visualize, and track endobronchial tools inside the radiolucent lesions in real time. LungVision instantly fuses intraoperative imaging with pre-operative CT.
The company said that the LungVision platform has shown better results through multicenter clinical trials in the US of over 400 clinical procedures.
Body Vision Medical CEO and Founder Medical Dorian Averbuch said: “The second release of LungVision allows real-time tool-in-lesion confirmation through C-Arm Based Tomography (CABT) to provide an accurate access to pulmonary nodules.
“LungVision 2.0 reveals fluoroscopically ‘blind’ lesions during biopsy sampling by means of any conventional C-Arm, which is widely available in a standard bronchoscopy suite. Real-time tool-in-lesion confirmation is required for successful diagnoses of pulmonary nodules and will ultimately be imperative in the future application of minimally invasive treatment.”
Body Vision Medical said that it is planning to showcase its new imaging platform at the ATS Annual Meeting 2019, held in Dallas through May 19-21.
Founded in 2014, Body Vision Medical is a medical device company specializing in augmented real-time imaging, artificial intelligence and intra-body navigation.
In May 2018, the company secured FDA clearance for its LungVision Tool, used in early-stage lung cancer diagnostics and treatment procedures, as part of LungVision Platform.
In May 2017, the company received the FDA clearance for the LungVison Imaging and Navigation System, which is a novel imaging system that enables accurate real-time navigation and lesion localization during bronchoscopic procedures.
In addition, the system’s synergistic imaging merges intraoperative fluoroscopy with pre-operative high resolution imaging, such as computed tomography.