SARATOGA, Calif., Sept. 28, 2026 (GLOBE NEWSWIRE) -- CapsoVision, Inc. (NASDAQ: CV), a commercial-stage medical technology company developing advanced imaging and AI-enabled capsule endoscopy solutions, today announced that AI Highlights™, its AI-assisted reading tool for the CapsoCam Plus system, received clearance from the U.S.

加利福尼亚州萨拉托加，2026年9月28日（环球电讯社）——CapsoVision, Inc.（纳斯达克股票代码：CV），一家致力于开发先进成像和人工智能赋能胶囊内镜解决方案的商业阶段医疗技术公司，今日宣布其用于CapsoCam Plus系统的人工智能辅助阅片工具AI Highlights™已获得美国相关机构的批准。

Food and Drug Administration (FDA) on September 25, 2026..

美国食品药品监督管理局（FDA）于2026年9月25日。

AI Highlights is designed to support physicians in the review of small bowel capsule endoscopy studies collected from adult and pediatric patients (over two years of age) in whom the study was performed due to suspected small bowel bleeding, specifically to reduce the time taken to review capsule endoscopy images.

AI Highlights 旨在支持医生审查从成人和儿科患者（两岁以上）收集的小肠胶囊内镜检查研究，这些检查是由于疑似小肠出血而进行的，特别是为了减少审查胶囊内镜图像所需的时间。

It does so through recognizing and marking images containing suspected abnormal lesions, which are highlighted and prioritized for physician review. The feature integrates with CapsoView®, CapsoVision’s video processing and review software, and supports workflows connected to the Company’s CapsoCloud® platform.

该功能通过识别并标记包含疑似异常病变的图像来实现这一目标，这些图像会被高亮显示并优先供医师审阅。该功能与 CapsoVision 公司的视频处理和审阅软件 CapsoView® 集成，并支持与该公司 CapsoCloud® 平台相连的工作流程。

During video processing, the AI algorithm analyzes frames captured by the CapsoCam Plus capsule. AI-processed studies can then support physician review within connected CapsoView or CapsoCloud workflows, depending on workflow configuration..

在视频处理过程中，AI算法会分析由CapsoCam Plus胶囊内镜捕获的帧。经过AI处理的检查数据随后可支持医师在相连的CapsoView或CapsoCloud工作流中进行审阅，具体取决于工作流的配置。

“FDA clearance of AI Highlights represents an important milestone in the continued evolution of the CapsoVision platform and our commitment to bringing integrated, AI-assisted technologies to physicians in the United States,” said Johnny Wang, President and Chief Executive Officer of CapsoVision. “Following the international launch of AI Highlights earlier this year, including in the European Union under the Medical Device Regulation, we are pleased to reach this important regulatory milestone in the United States.

“FDA对AI Highlights的许可代表了CapsoVision平台持续发展中的重要里程碑，也体现了我们致力于向美国医生提供集成式、人工智能辅助技术的承诺。”CapsoVision总裁兼首席执行官Johnny Wang表示。“在今年早些时候于国际范围（包括在欧盟根据《医疗器械法规》）推出AI Highlights之后，我们很高兴在美国达成这一重要的监管里程碑。”

We believe AI-assisted review tools may help support physician efficiency and may help improve reading performance as capsule endoscopy adoption continues to expand.”.

“我们相信，随着胶囊内镜应用的不断扩展，人工智能辅助审阅工具可能有助于提高医师的工作效率，并可能改善阅片表现。”

Integrated within the CapsoVision ecosystem, AI Highlights works across the connected CapsoCloud workflow to support capsule endoscopy review without the need for a separate AI platform. Where and when available, CapsoCloud enables organizations to securely access AI-processed videos for remote physician review, collaboration, and case management..

AI Highlights 集成于 CapsoVision 生态系统中，可在互联的 CapsoCloud 工作流中运行，无需借助独立的 AI 平台即可支持胶囊内镜检查的阅片。在具备条件的地区和时间，CapsoCloud 使医疗机构能够安全地访问经 AI 处理的视频，用于远程医师阅片、协作及病例管理。

The AI Highlights reading tool that was reviewed and cleared by the FDA represents a part of comprehensive updates to the CapsoView and CapsoCloud software. AI Highlights is intended to be used by trained healthcare professionals and is not intended to replace gastroenterologists’ diagnostic interpretation or, where applicable, histopathological sampling.

经美国食品药品监督管理局（FDA）审查并批准的AI Highlights阅读工具，代表了CapsoView和CapsoCloud软件全面更新的一部分。AI Highlights旨在由经过培训的医疗专业人员使用，并不旨在取代胃肠病学家的诊断解读，或在适用情况下取代组织病理学取样。

Please refer to the product’s Instructions for Use for complete information regarding indications, contraindications, warnings, precautions, and limitations..

有关适应症、禁忌症、警告、注意事项和限制的完整信息，请参阅产品的使用说明书。

About CapsoVision

关于 CapsoVision

CapsoVision is a commercial-stage medical technology company focused on developing advanced imaging and AI-enabled solutions to transform the detection and screening of gastrointestinal diseases. Its flagship product, CapsoCam Plus®, is a wire-free, panoramic capsule endoscope that enables high-resolution visualization of the small bowel and supports cloud-based or direct capsule video review.

CapsoVision 是一家处于商业化阶段的医疗技术公司，专注于开发先进的成像和人工智能赋能解决方案，以变革胃肠道疾病的检测与筛查。其旗舰产品 CapsoCam Plus® 是一款无线全景胶囊内镜，能够实现小肠的高分辨率可视化，并支持基于云端或直接进行胶囊视频阅片。

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.

公司的下一款在研产品为搭载增强型人工智能的 CapsoCam Colon™，旨在实现无创结肠成像及息肉检测。凭借专有的技术平台，CapsoVision 正将应用范围拓展至包括食管和胰腺疾病在内的多种胃肠道适应症，从而推动胶囊诊断进入新时代。

For more information on CapsoVision, please visit www.capsovision.com..

如需了解更多关于 CapsoVision 的信息，请访问 www.capsovision.com。

Forward-Looking Statements

前瞻性陈述

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 “expected,” “anticipate(s),” “intend(s),” “plan(s),” “believe(s),” “potential,” “will,” “should,” “could,” “would,” “may,” “continue,” “remain,” “target(ed)”, 'expand', or 'improve' and other words of similar meaning.

本新闻稿包含经修订的《1995年私人证券诉讼改革法案》所界定的前瞻性陈述。在此语境下，前瞻性陈述是指与未来事件相关的陈述，这些事件可能会影响我们预期的未来业务和财务表现，且通常包含“预期”、“预计”、“打算”、“计划”、“相信”、“潜在”、“将”、“应当”、“能够”、“会”、“可能”、“继续”、“保持”、“目标”、“扩张”或“改善”等词语以及具有类似含义的其他词语。

Examples of these forward-looking statements include, but are not limited to, statements concerning possible or assumed future results of operations and financial position, including the Company’s expectations regarding the Company’s product and clinical development efforts, the timing and receipt of regulatory submissions and approvals, the Company’s plans, strategies and timing for its pipeline development the Company’s expectations regarding the potential benefits of AI-assisted review tools to support physician efficiency and reading performance, the Company’s expectations regarding continued expansion of capsule endoscopy adoption, and the success of the Company’s plans and strategies.

这些前瞻性陈述的示例包括但不限于，有关可能或假设的未来经营业绩和财务状况的陈述，包括本公司对产品与临床开发工作的预期、监管申报与批准的时间及获取情况、本公司管线开发的计划、策略及时间安排、本公司对人工智能辅助审阅工具在提升医师工作效率和阅片表现方面潜在效益的预期、本公司对胶囊内镜应用持续扩大的预期，以及本公司计划与策略的成功实施。

These forward-looking statements are based on the Company’s current expectations and inherently involve significant risks and uncertainties, including those beyond the Company’s 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 (including competition in the capsule endoscopy market), the Company’s financial condition and the availability of cash and financing, and the success o.

这些前瞻性陈述基于公司当前的预期，并 inherently 涉及重大风险和不确定性，包括那些超出公司控制范围的因素。由于这些风险和不确定性，实际结果和事件发生的时间可能与前述前瞻性陈述中的预期存在重大差异。这些风险和不确定性包括但不限于：市场状况（包括胶囊内镜市场的竞争）、公司的财务状况以及现金和融资的可获得性，以及成功 o.

Investor Relations Contact

投资者关系联系人

Leigh Salvo

莱伊·萨尔沃

New Street Investor Relations

新街投资者关系

Investors@CapsoVision.com

Investors@CapsoVision.com

Media Contact

媒体联系人

Leslie Strickler and Paul Spicer

莱斯利·斯特里克勒和保罗·斯派塞

Être Communications

Être 通信

leslies@etrecommunications.com | (804) 240-0807

leslies@etrecommunications.com | (804) 240-0807

pauls@etrecommunications.com | (804) 503-9231

pauls@etrecommunications.com | (804) 503-9231