AnX Robotica, a company involved in the development of gastrointestinal visualization technologies, announces US Food and Drug Administration (FDA) clearance of their NaviCam ProScan, an artificial intelligence (AI) assisted reading tool to “revolutionise” the field of gastroenterology.
Through 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. AnX Robotics ProScan is a step forward in capsule endoscopy by enabling physicians with the latest technology to efficiently care for their patients, a press release states.
“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 Cristiano Spada (Gemelli Hospital, Rome, Italy). “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 said to complement 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.”
