AnX Robotica has received approval from the US Food and Drug Administration (FDA) for its NaviCam ProScan, an artificial intelligence (AI)-assisted reading tool for small bowel video capsule endoscopy.

ProScan is said to be the first AI-based tool that supports small bowel capsule endoscopy reviewers for adult patients.

It is designed for patients in whom the capsule endoscopy images were gathered for suspected small bowel bleeding.

The clearance for ProScan follows the De Novo Submission Process of the American health regulator.

The reading tool uses advanced technology to transform the area of gastroenterology.

According to AnX Robotica, ProScan is a major advancement in capsule endoscopy as it provides doctors with the newest technologies to treat patients effectively.

AnX Robotica marketing and product management vice president Stu Wildhorn said: “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.

“ProScan’s clearance underscores its potential to significantly enhance diagnostic workflows, allowing clinicians to make more informed decisions in a timely manner.”

ProScan software is meant to enhance physician knowledge and is not intended to take the role of a doctor’s clinical judgment.

AnX Robotica said that the tool functions as a support system and empowers medical practitioners to make well-informed judgments quickly and effectively with the aid of AI-assisted readings.

The company is now planning to extend the NaviCam platform to include more visualisation tools and therapeutic uses.

This latest clearance follows the clearance of ProScan and the development of the NaviCam Magnetically Controlled Capsule Endoscopy System.

The firm also sells the NaviCam Colon System in Europe in addition to the NaviCam SB System.

In the US, AnX Robotica provides radiopaque markers for colonic transit studies, called IntraMarX 3D.