The First AI-Assisted Video Capsule Endoscopy: FDA Approves AnX Robotica's ProScan
Digital Health |
5 January 2024
AnX Robotica announced that its AI-assisted tool for small bowel capsule endoscopy has received FDA clearance. With this approval, NaviCam ProScan becomes the first AI-assisted tool in its field. It is specifically designed to aid in diagnosing adult patients suspected of gastrointestinal bleeding. This innovative tool enhances diagnostic accuracy with an exceptional 99% sensitivity in identifying abnormalities and supports physician decision-making.
Gastrointestinal bleeding, a symptom of various disorders like hemorrhoids, peptic ulcers, and esophageal complications, has long challenged medical professionals. ProScan's efficiency stems from a comprehensive training on over 150,000 images from 1,971 patients, achieving a remarkable sensitivity of 99.88% in per-patient analysis and 99.90% in per-lesion analysis. These numbers speak volumes about the tool's precision and reliability.
"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. This clearance marks a significant leap forward in our pursuit of elevating patient care standards and signifies a new era in gastroenterological diagnostics," stated Dr. Cristiano Spada, Professor of Gastroenterology at Gemelli Hospital.
This groundbreaking AI-assisted small bowel capsule endoscopy represents a significant advancement in gastroenterological diagnostics and patient care. It showcases the growing importance of AI in medicine, marking a milestone that fuses advanced technology with medical expertise.
"ProScan's clearance underscores its potential to significantly enhance diagnostic workflows, allowing clinicians to make more informed decisions in a timely manner" said Stu Wildhorn, Vice President of Marketing and Product Management at AnX Robotica.
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