Company Preparing to Commence Commercialization Following U.S. FDA 510(k) ClearanceSARATOGA, Calif., Dec. 29, 2025 (GLOBE NEWSWIRE) -- CapsoVision, Inc. (NASDAQ: CV), a commercial-stage medical technology company developing advanced imaging and AI-enabled capsule endoscopy solutions, today announced submission of its 510(k) application to the Food and Drug Administration (FDA) for its proprietary AI-assisted module for CapsoCam Plus®. The addition of this reading tool will improve the detection of clinicall ...

Core Insights - CapsoVision, Inc. is participating in the Benchmark 14th Annual Discovery One-on-One Investor Conference on December 4, 2025, in New York City, with key executives attending [1][2] Company Overview - CapsoVision is a commercial-stage medical technology company focused on advanced imaging and AI-enabled solutions for gastrointestinal disease detection and diagnosis [3] - The flagship product, CapsoCam Plus®, is a wire-free, panoramic capsule endoscope that provides high-resolution visualization of the small bowel and supports cloud-based or direct video retrieval [3] - The upcoming product, CapsoCam Colon™, features enhanced AI for non-invasive colon imaging and polyp detection, with plans to expand across multiple gastrointestinal indications [3]

Core Insights - CapsoVision, Inc. has submitted an application to the FDA for Breakthrough Device Designation for its CapsoCam UGI capsule endoscopy system aimed at early detection of pancreatic ductal adenocarcinoma, a highly fatal cancer [1][5] - The CapsoCam UGI system is designed to expand the company's diagnostic capabilities beyond the small bowel, addressing significant challenges in gastroenterology [2][8] - Pancreatic ductal adenocarcinoma has a low five-year survival rate of only 8%, primarily due to late-stage diagnosis, highlighting the urgent need for effective early screening tools [2][6] Company Overview - CapsoVision is a commercial-stage medical technology company focused on advanced imaging and AI-enabled solutions for gastrointestinal disease detection [8] - The flagship product, CapsoCam Plus®, is a wire-free, panoramic capsule endoscope that provides high-resolution visualization of the small bowel [8] - The company is also developing CapsoCam Colon™, which aims to enhance non-invasive colon imaging and polyp detection [8] Industry Context - Pancreatic cancer is the third leading cause of cancer-related deaths in the U.S., despite representing only about 3% of all cancer cases [6] - Approximately 80% of pancreatic cancer diagnoses occur at advanced stages, limiting treatment options [6] - Current diagnostic methods are invasive and costly, lacking the sensitivity needed for early-stage detection, which underscores the need for innovative, non-invasive technologies [6][7]

Core Insights - CapsoVision, Inc. has appointed David Garcia as Senior Vice President of Finance to support its growth phase [1][3] - Garcia brings over 20 years of financial leadership experience, including roles in corporate finance and capital markets [2] - The company aims to leverage Garcia's expertise in financial management and capital strategy to advance its development pipeline and achieve corporate milestones [3] Company Overview - CapsoVision is a commercial-stage medical technology company focused on advanced imaging and AI-enabled solutions for gastrointestinal disease detection and diagnosis [4] - The flagship product, CapsoCam Plus®, is a wire-free capsule endoscope that provides high-resolution visualization of the small bowel [4] - The upcoming product, CapsoCam Colon™, will enhance non-invasive colon imaging and polyp detection using advanced AI [4]