CapsoVision, a medical device company, submitted a 510(k) application to the FDA for an AI-assisted module designed for its CapsoCam Plus capsule endoscopy platform.
The tool aims to improve detection of clinically significant small bowel pathology and reduce review time for clinicians. U.S. commercialization is expected to begin after FDA clearance, according to a Dec. 29 news release.
CapsoCam Plus is indicated for small bowel visualization in patients aged 2 and older. The system offers advantages over other capsule endoscopy solutions through its imaging approach, clinical workflow and patient experience.
The company’s AI tools are developed internally and operate on a cloud-based platform that does not require on-site servers, according to the release.
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