AnX Robotica has announced that the US Food and Drug Administration (FDA) has provided FDA clearance of its artificial intelligence (AI)-assisted reading tool to aid small bowel capsule endoscopy.
Through the FDA’s clearance, NaviCam ProScan is the first AI-assisted reading tool for adult patients who were suspected to have gastrointestinal bleeding.
Gastrointestinal bleeding is a sign of a disorder inside the digestive tract. Many conditions can cause small bowel bleeding, including haemorrhoids, peptic ulcers, tears or inflammation in the oesophagus.
First launched in February last year, ProScan works to improve capsule endoscopy by supporting physicians and clinicians with the latest technology to care for their patients more efficiently.
Leveraging cutting-edge technology, the tool serves as a support system, as opposed to replacing the clinical decision-making of physicians, and the AI-assisted readings will help enable healthcare professionals to make well-informed decisions.
In a landmark study published in Gastroenterology, ProScan was trained to differentiate abnormal images from normal images using over 150,000 images collected from 1,971 patients.
The study revealed that the deep learning model identified abnormalities with a sensitivity of 99.88% in per-patient analysis and 99.90% in per-lesion analysis.
The “AI-assisted reading tool represents a pivotal advancement in small bowel capsule endoscopy” and “this clearance marks a significant leap forward in our pursuit of elevating patient care standards and signifies a new era in gastroenterological diagnostics,” said Dr Cristiano Spada, professor of gastroenterology and director, endoscopy and digestive surgery, Gemelli Hospital.
Stu Wildhorn, vice president, marketing and product management, AnX Robotica, said the company is “delighted” with the FDA’s clearance of the software.
He added: “ProScan’s clearance underscores its potential to significantly enhance diagnostic workflows, allowing clinicians to make more informed decisions in a timely manner.”
The FDA clearance builds on AnX Robotica’s aim of expanding the NaviCam platform for additional visualisation aids and therapeutic applications.
The company also markets the NaviCam Colon System in Europe and offers IntraMarX 3D, which is a radioplaque marker for colonic transit studies in the US.
