Regulatory Status

LungStage Pro does not meet the definition of a medical device under UK Medical Devices Regulations 2002, EU Medical Devices Regulation 2017/745, or US FDA regulations pursuant to the 21st Century Cures Act clinical decision support exemption.

LungStage Pro is intended to be used by qualified healthcare professionals as a reference and educational tool for lung cancer staging, perioperative risk estimation, and treatment pathway review.