January 3, 2024 (Press Release) Plano, TX – AnX Robotica, a pioneering force in advanced gastrointestinal visualization technologies, is excited to announce the FDA clearance of NaviCam ProScan™. Through the rigorous De Novo Submission Process, the FDA has granted clearance for ProScan, making it the first AI Assisted Reading Tool designed to aid small bowel capsule endoscopy reviewers for adult patients in whom the capsule endoscopy images were obtained for suspected small bowel bleeding.
ProScan software, an artificial intelligent (AI) assisted reading tool, leverages cutting-edge technology to revolutionize the field of gastroenterology. AnX Robotics ProScan is a significant step forward in capsule endoscopy by enabling physicians with the latest technology to efficiently care for their patients.
“As a clinician deeply immersed in the field of gastroenterology, I am thrilled to witness the FDA clearance of ProScan. This groundbreaking AI Assisted Reading Tool represents a pivotal advancement in small bowel capsule endoscopy, particularly for patients suspected of gastrointestinal bleeding”, stated Dr. Cristiano Spada, Professor of Gastroenterology and Director on Endoscopy and Digestive Surgery at Gemelli Hospital. “This clearance marks a significant leap forward in our pursuit of elevating patient care standards and signifies a new era in gastroenterological diagnostics.”
AnX Robotica’s ProScan software is a valuable tool that complements clinician expertise. Importantly, it is not designed to replace clinical decision-making of the physician, but serves as a support system, enabling healthcare professionals to make well-informed and efficient decisions with the support of AI-assisted readings.
“We are delighted to announce the FDA clearance of NaviCam ProScan, a transformative AI Assisted Reading Tool that addresses a critical need in the realm of small bowel capsule endoscopy,” said Stu Wildhorn, Vice President of Marketing and Product Management at AnX Robotica. “ProScan’s clearance underscores its potential to significantly enhance diagnostic workflows, allowing clinicians to make more informed decisions in a timely manner.”
With the clearance of ProScan and the innovation of the NaviCam® Magnetically Controlled Capsule Endoscopy System, AnX Robotica is working to expand the NaviCam® platform for additional visualization aids and therapeutic applications. In addition to the NaviCam SB System, AnX Robotica markets the NaviCam® Colon System in Europe. The company also offers IntraMarX® 3D, radiopaque markers for colonic transit studies in the US.
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