Sam Brusco, Associate Editor01.03.24
AnX Robotica has earned U.S. Food and Drug Administration (FDA) de novo clearance for NaviCam ProScan, an artificial-intelligence (AI)-assisted reading tool to help small bowel capsule endoscopy reviewers.
When NaviCam magnetically controlled capsule endoscopy captures images of suspected small bowel bleeding, the company said the newly-cleared ProScan software’s AI-assisted readings can help gastroenterological clinicians make well-informed and efficient decisions.
"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," said 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."
"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," added Stu Wildhorn, VP 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."
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 U.S.
When NaviCam magnetically controlled capsule endoscopy captures images of suspected small bowel bleeding, the company said the newly-cleared ProScan software’s AI-assisted readings can help gastroenterological clinicians make well-informed and efficient decisions.
"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," said 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."
"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," added Stu Wildhorn, VP 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."
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 U.S.