Gastroenterology: FDA Clears NaviCam ProScan

The U.S. Food and Drug Administration (FDA) has officially cleared AnX Robotica’s NaviCam ProScan, an innovative AI-assisted reading tool designed to streamline the assessment of small bowel capsule endoscopy in adults.

This significant decision was reached through the De Novo Submission Process, emphasizing the pioneering nature of the ProScan software within the field of gastroenterology.

“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.” Wildhorn added.

AI-assisted reading tool

ProScan harnesses the power of artificial intelligence (AI) to provide vital support to clinicians interpreting capsule endoscopy images, commonly employed in diagnosing gastrointestinal conditions.

AnX Robotica’s ProScan software serves as a valuable tool that enhances clinician expertise. Crucially, its design emphasizes collaboration rather than replacement in clinical decision-making.

The technology is intended to support healthcare professionals, providing AI-assisted readings that empower them to make well-informed and efficient decisions in patient care.

The company emphasizes that ProScan is a significant step forward in capsule endoscopy by enabling physicians with the latest technology to efficiently care for their patients.

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“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 and Director on Endoscopy and Digestive Surgery at Gemelli Hospital.

With the approval of ProScan and the introduction of the NaviCam Magnetically Controlled Capsule Endoscopy System, AnX Robotica has outlined its strategic vision to extend the NaviCam platform. The aim is to incorporate additional visualization aids and therapeutic applications, thereby advancing the platform’s capabilities to new heights.

Gastroenterology

Gastroenterology is the study of the normal function and diseases of the oesophagus, stomach, small intestine, colon and rectum, pancreas, gallbladder, bile ducts and liver.

It involves a detailed understanding of the normal action (physiology) of the gastrointestinal organs including the movement of material through the stomach and intestine (motility), the digestion and absorption of nutrients into the body, removal of waste from the system, and the function of the liver as a digestive organ.

It includes common and important conditions such as colon polyps and cancer, hepatitis, gastroesophageal reflux (heartburn), peptic ulcer disease, colitis, gallbladder and biliary tract disease, nutritional problems, Irritable Bowel Syndrome (IBS), and pancreatitis. In essence, all normal activity and disease of the digestive organs is part of the study of Gastroenterology.