AnX Robotica receives FDA clearance for small bowel capsule endoscopy technology
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.
Key Points:
- NaviCam ProScan is the first AI-assisted reading tool for small bowel capsule endoscopy that has received FDA clearance.
- ProScan works to improve capsule endoscopy by supporting physicians and clinicians with the latest technology to care for their patients more efficiently.
- A study published in Gastroenterology showed that ProScan identified abnormalities with a sensitivity of 99.88% and 99.90% in per-patient and per-lesion analysis, respectively.
- AnX Robotica aims to expand the NaviCam platform for additional visualisation aids and therapeutic applications.
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.
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.