FDA grants de novo clearance to AnX Robotica’s AI tool for small bowel capsule endoscopy
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The FDA has granted de novo clearance to AnX Robotica for its “groundbreaking” artificial intelligence-assisted reading tool to aid in small bowel capsule endoscopy procedures, according to a company release.
With this clearance, AnX Robotica’s NaviCam ProScan is the first AI-assisted reading tool intended to support endoscopy reviewers in identifying patients with suspected small bowel bleeding from small bowel capsule endoscopy images.
“As a clinician deeply immersed in the field of gastroenterology, I am thrilled to witness the FDA clearance of ProScan,” Cristiano Spada, MD, PhD, director of endoscopy and digestive surgery at Gemelli Hospital in Rome, said in the release. “This groundbreaking AI Assisted Reading Tool represents a pivotal advancement in small bowel capsule endoscopy, particularly for patients suspected of gastrointestinal bleeding. This clearance marks a significant leap forward in our pursuit of elevating patient care standards and signifies a new era in gastroenterological diagnostics.”
The company noted that the ProScan software is “not designed to replace clinical decision-making of the physician,” but rather intended to support clinician expertise, enabling clinicians to make well-informed and efficient decisions backed by 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,” Stu Wildhorn, vice president of marketing and product management at AnX Robotica, said. “ProScan’s clearance underscores its potential to significantly enhance diagnostic workflows, allowing clinicians to make more informed decisions in a timely manner.”
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