LungVision

The LungVision device is designed to improve the precision of endobronchial tool guidance during pulmonary procedures. It achieves this by integrating pre-acquired 3D CT datasets with live fluoroscopic X-ray images, providing clinicians with real-time, three-dimensional navigational insights for targeted interventions.

BodyVision Ltd.'s LungVision device has secured substantial equivalence determination, enabling its market release as a Class II Medical Image Management and Processing System. Its primary purpose is to enhance catheter and device navigation during pulmonary procedures by segmenting pre-acquired 3D CT datasets and accurately overlaying and registering them with live fluoroscopic X-ray images. This sophisticated methodology provides real-time planning information, tomographic images, and 3D views, effectively guiding endobronchial tools to specific areas of interest within a patient's lungs. The device's market approval is contingent upon adherence to general controls, including annual registration, device listing, good manufacturing practices, and precise labeling. It must also comply with the Quality System regulation, the Unique Device Identification System rule, and medical device reporting for adverse events. The LungVision system demonstrated its safety and effectiveness through comprehensive testing, encompassing bench tests, simulations with lung models, and clinical validation using historical data, confirming it met all specified requirements and achieved comparable accuracy to its predicate device.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How does the real-time registration accuracy of 3D CT data with live fluoroscopy compare in dynamic lung environments (e.g., during patient breathing)?; What is the specific impact of LungVision on procedure time, radiation exposure, and diagnostic yield compared to traditional bronchoscopy or navigation methods?; Are there specific patient cohorts or lung pathologies where LungVision demonstrates superior performance or has limitations?; What are the long-term clinical outcomes and complication rates associated with procedures guided by the LungVision system?; Has the system been validated for use with different types of endobronchial tools or for a broader range of interventional pulmonary procedures beyond navigation?