CapsoVision Inc. has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its proprietary artificial intelligence (AI)-assisted module for CapsoCam Plus. Adding this reading tool to the CapsoCam platform will improve the detection of clinically significant pathology, as well as reduce clinician review time, according to the company.

CapsoVision intends to begin U.S. commercialization of the product upon FDA clearance.

CapsoVision’s CapsoCam Plus capsule endoscopy system is intended to visualize the small bowel mucosa to detect small bowel abnormalities in adults and children aged two years and older. The company claims that the system is a more advanced capsule endoscopy solution compared to competitor systems, both in the way it captures and presents images of the GI tract and the clinical workflow and patient experience it enables.

“This submission marks an important milestone in our commitment to customers and patients towards advancing a best-in-class solution that integrates advanced imaging with AI-powered interpretation for small bowel diagnostics,” CapsoVision President/CEO Johnny Wang stated. “We believe we are the only capsule endoscopy company with in-house AI core competency, and the scale and quality of our growing image data trove create a foundation for training AI models and uncovering new clinical insights that will set our platform apart from competitive options. Combined with our fully cloud-based architecture—which eliminates the need for on-site servers, reduces cost and downtime, and removes the burden of IT maintenance—we are delivering an AI-enabled diagnostic platform designed to bring efficiency, accuracy, and accessibility to GI practices of all sizes.”

CapsoVision is a commercial-stage medical technology company developing advanced imaging and AI-enabled solutions to transform gastrointestinal disease detection and diagnosis. Its flagship product, CapsoCam Plus, is a wire-free, panoramic capsule endoscope that enables high-resolution small bowel visualization and supports cloud-based or direct capsule video retrieval. The company’s next pipeline product, CapsoCam Colon with enhanced AI, is designed to enable non-invasive colon imaging and polyp detection. With a proprietary platform targeted to expand across multiple GI indications, including esophageal and pancreatic disorders, CapsoVision is advancing a new era in capsule-based diagnostics.