01 / The product

What is AI Highlights for CapsoCam Plus?

AI Highlights is an AI-assisted reading tool developed by CapsoVision, Inc. for the CapsoCam Plus capsule endoscopy system. It is designed to help physicians review small bowel capsule endoscopy studies by marking images that contain suspected abnormal lesions.

CapsoVision, Inc. (NASDAQ: CV), which issued the announcement from Saratoga, California, describes itself as a commercial-stage medical technology company developing advanced imaging and AI-enabled capsule endoscopy solutions. Its flagship product, CapsoCam Plus, is described by the company as a wire-free, panoramic capsule endoscope that enables high-resolution visualization of the small bowel and supports cloud-based or direct capsule video review.

Capsule endoscopy is a different modality from the flexible endoscopy equipment used in gastroscopy and colonoscopy suites. The announcement concerns review software for capsule studies, not video processors, light sources or scopes.

02 / The clearance

What exactly did the FDA clear for CapsoCam Plus?

The FDA clearance announced by CapsoVision covers AI Highlights as a tool to support physicians reviewing small bowel capsule endoscopy studies performed due to suspected small bowel bleeding, in adult and pediatric patients over two years of age.

According to the release, the stated purpose of AI Highlights is specifically to reduce the time taken to review capsule endoscopy images. It does so by recognizing and marking images that contain suspected abnormal lesions, which are then highlighted and prioritized for the physician.

1. 01Scope

   A defined indication. The clearance is tied to small bowel capsule studies performed for suspected small bowel bleeding, not to every capsule exam or every GI indication.

   From the releaseAdult and pediatric patients over two years of age.
2. 02Role

   A reading aid, not a diagnosis. AI Highlights is intended to be used by trained healthcare professionals. CapsoVision states it is not intended to replace gastroenterologists’ diagnostic interpretation or, where applicable, histopathological sampling.

   From the releaseRefer to the Instructions for Use for indications, contraindications, warnings, precautions and limitations.
3. 03Package

   Part of a wider software update. The cleared AI Highlights reading tool is described as one part of comprehensive updates to the CapsoView and CapsoCloud software.

   From the releaseNo separate AI platform is required.

03 / The workflow

How does AI Highlights work in the capsule review workflow?

AI Highlights runs during video processing: the AI algorithm analyzes the frames captured by the CapsoCam Plus capsule, and the AI-processed study then supports physician review inside connected CapsoView or CapsoCloud workflows, depending on workflow configuration.

CapsoVision says the tool works across the connected CapsoCloud workflow without the need for a separate AI platform. The company also notes that cloud-based remote review is offered where and when available, so access can vary by site and configuration. For flexible endoscopy imaging, see our guide to DICOM in endoscopy and medical imaging.

1. CaptureThe CapsoCam Plus capsule captures the frames of the small bowel study.
2. ProcessDuring video processing, the AI algorithm analyzes those frames.
3. HighlightImages with suspected abnormal lesions are marked, highlighted and prioritized.
4. ReviewThe physician reviews the study in CapsoView or CapsoCloud and makes the interpretation.

04 / The timeline

What happened before and after the AI Highlights clearance?

The U.S. clearance of AI Highlights followed an international launch earlier in 2026, according to CapsoVision President and Chief Executive Officer Johnny Wang.

Wang called the clearance “an important milestone in the continued evolution of the CapsoVision platform.” He added that AI Highlights had launched internationally earlier in the year, including in the European Union under the Medical Device Regulation. He said the company believes AI-assisted review tools could help physician efficiency and reading performance as capsule endoscopy adoption grows. These are the company’s expectations, and the release presents them within its forward-looking statements.

1. 2026

   International launch. AI Highlights launched internationally earlier in the year, including in the European Union under the Medical Device Regulation.

2. Sep 25

   FDA clearance. AI Highlights for the CapsoCam Plus system received clearance from the U.S. FDA.

3. Sep 28

   Announcement. CapsoVision announced the clearance in a press release distributed by GlobeNewswire.

4. Next

   Pipeline. CapsoVision names CapsoCam Colon with enhanced AI as its next pipeline product, designed to enable non-invasive colon imaging and polyp detection.

05 / Endoscopy context

What does the CapsoCam Plus news mean for endoscopy departments?

AI Highlights is software for CapsoCam Plus capsule studies. It is not a feature of video gastroscopes, colonoscopes or endoscopy towers, so it does not change how those systems work.

Capsule studies and flexible endoscopy are separate procedures that use separate equipment. The release itself notes that AI Highlights does not replace histopathological sampling where applicable. For departments planning their video gastroscope or colonoscopy fleet, the news is useful industry context rather than a reason to change flexible equipment.

Departments that compare processor generations can also read our analysis of the Olympus CV-190 and EVIS X1, and teams that need equipment for a limited period can review endoscopy equipment rental. For laparoscopic suites, see our video surgery equipment line.