{"id":922787,"date":"2025-12-29T16:08:54","date_gmt":"2025-12-29T21:08:54","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/capsovision-announces-510k-submission-for-the-addition-of-ai-assisted-reading-module-in-capsocam-plus\/"},"modified":"2025-12-29T16:08:54","modified_gmt":"2025-12-29T21:08:54","slug":"capsovision-announces-510k-submission-for-the-addition-of-ai-assisted-reading-module-in-capsocam-plus","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/capsovision-announces-510k-submission-for-the-addition-of-ai-assisted-reading-module-in-capsocam-plus\/","title":{"rendered":"CapsoVision Announces 510(k) Submission for the Addition of AI-Assisted Reading Module in CapsoCam Plus\u00ae"},"content":{"rendered":"<h2>\nCompany Preparing to Commence Commercialization Following U.S. FDA 510(k) Clearance<br \/>\n<\/h2>\n<div class=\"mw_release\">\n<p align=\"left\">SARATOGA, Calif., Dec.  29, 2025  (GLOBE NEWSWIRE) &#8212; 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\u00ae. The addition of this reading tool will improve the detection of clinically significant pathology, as well as reduce clinician review time. The Company intends for U.S. commercialization activities to commence after the FDA clearance.<\/p>\n<p align=\"left\">CapsoVision\u2019s CapsoCam Plus capsule endoscopy system is intended for visualization of the small bowel mucosa to detect abnormalities of the small bowel in adults and children aged two years and older. The Company believes that it is a more advanced capsule endoscopy solution compared to competitor systems, both in how it captures and presents images of the GI tract and the clinical workflow and patient experience that it enables.<\/p>\n<p align=\"left\">\u201cThis 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,\u201d said Johnny Wang, President and Chief Executive Officer. \u201cWe 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 powerful 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\u2014which eliminates the need for on-site servers, reduces cost and downtime, and removes the burden of IT maintenance\u2014we are delivering an AI-enabled diagnostic platform designed to bring efficiency, accuracy, and accessibility to GI practices of all sizes.\u201d<\/p>\n<p align=\"left\">\n        <strong>About CapsoVision<\/strong><br \/>\n        <br \/>CapsoVision is a commercial-stage medical technology company focused on developing advanced imaging and AI-enabled solutions to transform the detection and diagnosis of gastrointestinal diseases. Its flagship product, CapsoCam Plus\u00ae, is a wire-free, panoramic capsule endoscope that enables high-resolution visualization of the small bowel and supports cloud-based or direct capsule video retrieval. The Company\u2019s next pipeline product, CapsoCam Colon\u2122 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. For more information on CapsoVision, please visit <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=7DTEQpk6lfp9avzvNXFF6tRjmMcsGHAUDn09VSq5QilkYfsuz-GmAABq-qovg0hHLkh19UDl2GesdwanTZgWHlMoxcIBhaEyriUf4CRRW3mEol7nrvMkZcCNP_Y2Wpokjg2nUZtAMlRaBWNiKlfThIpHTYfbUDZI7BOWs5SjTmIniMSiwN7ADZgphQAdSLIPzCItDLYQJXfk4Zh6QuFy16doGpGJRd7fcNUaSq5SFS6_7XDaIOcf3ucdKzLlN7kFD5mX_BCbR9RAYJOhElTxcuo8qtUK-Rm4mj2X80NBOoigY3LhJr4Q2rHRd1egTr2pgLLQsfuUa2-Fs3FstGl4ChKrwdhxfQBUUs9gk2xkz5inOTQmbVaZ_IIBuZ3AniLG\" rel=\"nofollow\" target=\"_blank\">www.capsovision.com<\/a>.<\/p>\n<p align=\"left\">\n        <strong>Forward-Looking Statements<\/strong><br \/>\n        <br \/>This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In this context, forward-looking statements mean statements related to future events, which may impact our expected future business and financial performance, and often contain words such as \u201cexpected\u201d, \u201canticipates\u201d, \u201cintends\u201d, \u201cplans\u201d, \u201cbelieves\u201d, \u201cpotential\u201d, \u201cwill\u201d, \u201cshould\u201d, \u201ccould\u201d, \u201cwould\u201d or \u201cmay\u201d and other words of similar meaning. Examples of these forward-looking statements include, but are not limited to, statements concerning possible or assumed future results of operations, including the timing and receipt of regulatory approvals, the Company\u2019s plans, strategies and timing for its pipeline development, and the success of the Company\u2019s plans and strategies. These forward-looking statements are based on the Company\u2019s current expectations and inherently involve significant risks and uncertainties, including those beyond the Company\u2019s control. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, market conditions and the failure to receive regulatory clearance. These and other risks and uncertainties are described more fully in the Company\u2019s filings with the Securities and Exchange Commission (\u201cSEC\u201d), including the \u201cRisk Factors\u201d section of the Company\u2019s prospectus filed on July 3, 2025 with the SEC, as part of the Company\u2019s Registration Statement on Form S-1 (File No. 333-287148), and the Company\u2019s most recent Form 10-Q. Forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to update or revise these statements, except as required by law.<\/p>\n<p align=\"left\">\n        <strong>Investor Relations Contact<\/strong><br \/>\n        <br \/>Leigh Salvo<br \/>New Street Investor Relations<br \/><u>Investors@CapsoVision.com<\/u><\/p>\n<p align=\"left\">\n        <strong>Media Contact<\/strong><br \/>\n        <br \/>Leslie Strickler and Paul Spicer<br \/>\u00catre Communications<br \/><u>leslies@etrecommunications.com<\/u> | (804) 240-0807<br \/><u>pauls@etrecommunications.com<\/u> | (804) 503-9231<\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTYxNzg3MSM3MzM4NzAyIzIyOTkzNzU=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/OWQyNzE2MDMtNGY3My00YzA5LThmZWUtZTdhMDYzN2Y4ZmU0LTEzMTA5MjUtMjAyNS0xMi0yOS1lbg==\/tiny\/CapsoVision.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Company Preparing to Commence Commercialization Following U.S. FDA 510(k) Clearance SARATOGA, Calif., Dec. 29, 2025 (GLOBE NEWSWIRE) &#8212; 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\u00ae. The addition of this reading tool will improve the detection of clinically significant pathology, as well as reduce clinician review time. The Company intends for U.S. commercialization activities to commence after the FDA clearance. CapsoVision\u2019s CapsoCam Plus capsule endoscopy system is intended for visualization of the small bowel mucosa to detect abnormalities of the small bowel in adults and children aged two years &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/capsovision-announces-510k-submission-for-the-addition-of-ai-assisted-reading-module-in-capsocam-plus\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;CapsoVision Announces 510(k) Submission for the Addition of AI-Assisted Reading Module in CapsoCam Plus\u00ae&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-922787","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CapsoVision Announces 510(k) Submission for the Addition of AI-Assisted Reading Module in CapsoCam Plus\u00ae - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/capsovision-announces-510k-submission-for-the-addition-of-ai-assisted-reading-module-in-capsocam-plus\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CapsoVision Announces 510(k) Submission for the Addition of AI-Assisted Reading Module in CapsoCam Plus\u00ae - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Company Preparing to Commence Commercialization Following U.S. FDA 510(k) Clearance SARATOGA, Calif., Dec. 29, 2025 (GLOBE NEWSWIRE) &#8212; 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\u00ae. The addition of this reading tool will improve the detection of clinically significant pathology, as well as reduce clinician review time. The Company intends for U.S. commercialization activities to commence after the FDA clearance. CapsoVision\u2019s CapsoCam Plus capsule endoscopy system is intended for visualization of the small bowel mucosa to detect abnormalities of the small bowel in adults and children aged two years &hellip; Continue reading &quot;CapsoVision Announces 510(k) Submission for the Addition of AI-Assisted Reading Module in CapsoCam Plus\u00ae&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/capsovision-announces-510k-submission-for-the-addition-of-ai-assisted-reading-module-in-capsocam-plus\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2025-12-29T21:08:54+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTYxNzg3MSM3MzM4NzAyIzIyOTkzNzU=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/capsovision-announces-510k-submission-for-the-addition-of-ai-assisted-reading-module-in-capsocam-plus\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/capsovision-announces-510k-submission-for-the-addition-of-ai-assisted-reading-module-in-capsocam-plus\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"CapsoVision Announces 510(k) Submission for the Addition of AI-Assisted Reading Module in CapsoCam Plus\u00ae\",\"datePublished\":\"2025-12-29T21:08:54+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/capsovision-announces-510k-submission-for-the-addition-of-ai-assisted-reading-module-in-capsocam-plus\\\/\"},\"wordCount\":705,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/capsovision-announces-510k-submission-for-the-addition-of-ai-assisted-reading-module-in-capsocam-plus\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=OTYxNzg3MSM3MzM4NzAyIzIyOTkzNzU=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/capsovision-announces-510k-submission-for-the-addition-of-ai-assisted-reading-module-in-capsocam-plus\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/capsovision-announces-510k-submission-for-the-addition-of-ai-assisted-reading-module-in-capsocam-plus\\\/\",\"name\":\"CapsoVision Announces 510(k) Submission for the Addition of AI-Assisted Reading Module in CapsoCam Plus\u00ae - 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(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\u00ae. The addition of this reading tool will improve the detection of clinically significant pathology, as well as reduce clinician review time. The Company intends for U.S. commercialization activities to commence after the FDA clearance. CapsoVision\u2019s CapsoCam Plus capsule endoscopy system is intended for visualization of the small bowel mucosa to detect abnormalities of the small bowel in adults and children aged two years &hellip; Continue reading \"CapsoVision Announces 510(k) Submission for the Addition of AI-Assisted Reading Module in CapsoCam Plus\u00ae\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/capsovision-announces-510k-submission-for-the-addition-of-ai-assisted-reading-module-in-capsocam-plus\/","og_site_name":"Market Newsdesk","article_published_time":"2025-12-29T21:08:54+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTYxNzg3MSM3MzM4NzAyIzIyOTkzNzU=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/capsovision-announces-510k-submission-for-the-addition-of-ai-assisted-reading-module-in-capsocam-plus\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/capsovision-announces-510k-submission-for-the-addition-of-ai-assisted-reading-module-in-capsocam-plus\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"CapsoVision Announces 510(k) Submission for the Addition of AI-Assisted Reading Module in CapsoCam Plus\u00ae","datePublished":"2025-12-29T21:08:54+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/capsovision-announces-510k-submission-for-the-addition-of-ai-assisted-reading-module-in-capsocam-plus\/"},"wordCount":705,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/capsovision-announces-510k-submission-for-the-addition-of-ai-assisted-reading-module-in-capsocam-plus\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTYxNzg3MSM3MzM4NzAyIzIyOTkzNzU=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/capsovision-announces-510k-submission-for-the-addition-of-ai-assisted-reading-module-in-capsocam-plus\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/capsovision-announces-510k-submission-for-the-addition-of-ai-assisted-reading-module-in-capsocam-plus\/","name":"CapsoVision Announces 510(k) Submission for the Addition of AI-Assisted Reading Module in CapsoCam Plus\u00ae - 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