AnX Robotica has announced the FDA clearance of NaviCam ProScan™, a groundbreaking AI-assisted reading tool for small bowel video capsule endoscopy. This clearance, achieved through the rigorous De Novo Submission Process, makes ProScan the first AI-assisted reading tool designed to aid in reviewing small bowel capsule endoscopy images for adult patients suspected of small bowel bleeding. ProScan leverages advanced AI technology to enhance the field of gastroenterology, enabling physicians to efficiently care for their patients.
Dr. Cristiano Spada, a gastroenterology expert, praised this development as a significant advancement in small bowel capsule endoscopy, especially for patients with suspected gastrointestinal bleeding. ProScan is intended to complement clinician expertise, not replace it, serving as a support system for healthcare professionals to make well-informed and efficient decisions. This FDA clearance marks a significant step in AnX Robotica’s efforts to advance medical technology in gastroenterology.