CapsoVision Submits AI-Powered Diagnostic Tool to FDA for CapsoCam Plus®

SARATOGA, CA – December 29, 2025 – CapsoVision, Inc., a medical technology firm specializing in gastrointestinal imaging, announced today it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA). The submission is for a new artificial intelligence (AI) module designed to assist clinicians in reading images from its CapsoCam Plus® capsule endoscopy system.

Enhancing Diagnostic Efficiency with AI

The company stated that the proprietary AI-assisted reading tool is engineered to improve the detection of clinically significant pathologies within the small bowel and significantly reduce the time clinicians spend reviewing the thousands of images captured during a procedure. Following potential FDA clearance, CapsoVision plans to launch the module commercially in the United States.

The CapsoCam Plus system is a wire-free, ingestible capsule endoscope used to visualize the small bowel mucosa in adults and children aged two and older. The device is designed to detect abnormalities, such as bleeding or tumors, in a non-invasive manner. According to the company, its panoramic imaging system and cloud-based workflow offer a more advanced solution compared to competing systems on the market, enhancing both the clinical process and the patient experience.

A Strategic Move Towards AI Integration

Johnny Wang, President and Chief Executive Officer of CapsoVision, framed the FDA submission as a key achievement in the company's strategy. “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,” Wang said in a press release.

Wang emphasized the company's in-house AI development capabilities, suggesting this gives CapsoVision a competitive edge. He noted that the company's extensive and growing library of image data provides a robust foundation for training its AI models. “We believe we are the only capsule endoscopy company with in-house AI core competency,” he stated. “The scale and quality of our growing image data trove create a powerful foundation for training AI models and uncovering new clinical insights that will set our platform apart.”

He also highlighted the benefits of the system's cloud-based architecture, which eliminates the need for expensive on-site servers, reduces IT maintenance for clinics, and minimizes downtime. The goal, according to Wang, is to deliver an AI-enabled platform that brings greater “efficiency, accuracy, and accessibility to GI practices of all sizes.”

The Future of GI Diagnostics

CapsoVision is positioning itself as a leader in transforming the diagnosis of gastrointestinal diseases. The company's flagship product, CapsoCam Plus, is already commercially available. Beyond the small bowel, CapsoVision is developing future products aimed at other parts of the GI tract.

Its pipeline includes CapsoCam Colon™, which will incorporate enhanced AI for non-invasive colon imaging and polyp detection. The company also has plans to expand its proprietary platform to address other conditions, including esophageal and pancreatic disorders, signaling a broad ambition to revolutionize capsule-based diagnostics.

The company has indicated that its forward-looking plans, including the timing of regulatory approvals and future product development, are subject to significant risks and uncertainties. Commercialization of the new AI module is contingent upon receiving 510(k) clearance from the FDA.