Deep Capsule

by Digestaid - Artificial Intelligence Development SA  · Based in Portugal →AI assistance for acquired capsule endoscopy videos.
Gastroenterology

Regulatory Status Disclosed

Overview

Deep Capsule is a non-invasive deep learning software driven by artificial intelligence (AI) designed to identify and differentiate normal mucosa and small bowel lesions in images from previously acquired capsule endoscopy videos. It assists in the post-procedural review of small bowel capsule endoscopy examinations by detecting and differentiating lesions, stratifying hemorrhagic potential, and bringing clinically relevant frames into focus for physician validation. The software supports clinicians throughout the review process while ensuring that the final interpretation remains in expert hands.

Digestaid, the company behind Deep Capsule, focuses on developing accurate deep learning solutions for the detection of digestive lesions, aiming to revolutionize gastrointestinal practice with AI technologies across digestive and pancreatobiliary tracts, as well as functional tests. They leverage a team of gastroenterologists and engineers to innovate in digestive healthcare.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Non-invasive deep learning solution for small bowel mucosa evaluation
  • Detects and differentiates lesions (vascular lesions, protruding lesions, ulcers, erosions, blood)
  • Stratifies hemorrhagic potential using a validated scale
  • Brings clinically relevant frames into focus for physician validation
  • Multi-device interoperability (validated with full-length videos from three different capsule endoscopy devices)
  • Rapid assisted review (mean AI-assisted reading time of 203 seconds per examination)
  • Improved detection of clinically relevant small bowel lesions
  • Faster review of long capsule endoscopy examinations
  • Reduced risk of overlooking findings across thousands of frames
  • Consistent lesion characterization

Use Cases

  • Post-procedural review of small bowel capsule endoscopy examinations
  • Aid in identifying and differentiating lesions in the small bowel mucosa
  • Detection of lesions in patients aged 18 or above with suspected small bowel disease
  • Assisting in cases of suspected middle gastrointestinal bleeding
  • Supporting inflammatory bowel disease assessment
  • Aiding in digestive oncology evaluations

What Physicians Need to Know

Polyp Detection During Colonoscopy
Deep Capsule is primarily designed for small bowel capsule endoscopy, not colonoscopy. However, AI-assisted colon capsule endoscopy (CCE) tools have shown high sensitivity (93.44%) and specificity (94.63%) for detecting colorectal polyps, significantly reducing review time and improving detection rates compared to traditional methods.
Real-Time Endoscopy AI
Deep Capsule focuses on post-procedural review of acquired capsule endoscopy videos. While current AI in capsule endoscopy is largely for post-procedure analysis, future innovations are expected to integrate real-time AI within the capsule itself for immediate analysis and even autonomous movement.
Adenoma Detection Rate Improvement
Deep Capsule's focus is on detecting and differentiating various small bowel lesions, including vascular and protruding lesions, ulcers, erosions, and blood, rather than specifically adenomas in the colon. However, AI in CCE has shown to increase polyp detection sensitivity.
GI Pathology Analysis
Deep Capsule supports comprehensive small bowel lesion review, identifying and differentiating pleomorphic lesions, characterizing findings, and stratifying hemorrhagic potential. It identifies vascular and protruding lesions, ulcers, erosions, and blood.
IBD Assessment Tools
Deep Capsule is not specifically marketed as an IBD assessment tool, but AI-assisted capsule endoscopy, such as IBD Smartu00ae, is being developed to detect ulcers and erosions in panendoscopy exams for inflammatory bowel activity, particularly in Crohn's disease, with high sensitivity and specificity.
Capsule Endoscopy AI
Deep Capsule is an AI assistance tool for post-procedural review of small bowel capsule endoscopy videos. It detects and differentiates lesions, stratifies hemorrhagic potential, and brings clinically relevant frames into focus for physician validation. It has a validated lesion-detection rate of 96.1% and can significantly reduce reading times.
Procedure Documentation
Deep Capsule assists clinicians in the review process, allowing them to validate findings in their clinical context and complete diagnostic reports. It also allows for adding medical notes and re-validating AI findings.
Quality Metrics Tracking
Deep Capsule focuses on improving the efficiency and accuracy of capsule endoscopy review by prioritizing relevant frames and differentiating lesions, which indirectly contributes to quality metrics by reducing missed lesions and reading times.
Endoscopy System Compatibility
Deep Capsule is validated with full-length videos acquired from three different capsule endoscopy devices, including the Jinshan OMOMu00ae HD Capsule Endoscopy System, GIVEN PillCamu2122 family of devices (PillCamu2122 SB1, PillCamu2122 SB2, PillCamu2122 SB3), and ENDOCAPSULE 10 System medical devices.
Physician Tip

Utilize Deep Capsule for efficient post-procedural review of small bowel capsule endoscopy videos, focusing on its ability to highlight and differentiate lesions, and stratify bleeding risk. Always maintain final interpretation in expert hands, using the AI as a powerful assistive tool to reduce reading time and improve diagnostic focus. Be aware that while Deep Capsule excels in small bowel analysis, other AI tools are emerging for colon capsule endoscopy and real-time applications.

Deep Capsule is designed to process previously acquired capsule endoscopy videos and is compatible with major capsule endoscopy systems like Jinshan OMOMu00ae HD, GIVEN PillCamu2122 (SB1, SB2, SB3), and ENDOCAPSULE 10. Ensure your existing capsule endoscopy acquisition workflow can seamlessly export videos for Deep Capsule's review process.

Details

Category Gastroenterology AI
Pricing Unknown unknown
DeploymentWeb-based application (requires updated browser, 4GB RAM, 1GHz CPU, 200GB storage, 1280x1024 screen resolution, stable broadband internet)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Cleared AI-estimated

Deep Capsule® (Deep Capsule US) received FDA 510(k) clearance. It is an AI-assisted reading tool designed to aid small bowel capsule endoscopy reviewers for adult patients in whom the capsule endoscopy images were obtained for suspected small bowel bleeding.

Integrations
EHR Not specified
Specialties Gastroenterology

What the Web Says

Deep Capsule is an AI-assisted reading system designed for small bowel capsule endoscopy (CapE) examinations. It aims to improve the detection and differentiation of lesions, reduce reading times for physicians, and minimize the risk of overlooking clinically relevant findings. The technology has received FDA approval, indicating growing acceptance of AI in ingestible imaging devices.

Overall: Positive

Strengths

  • Superior sensitivity in detecting lesions compared to standard-of-care reading.
  • Significantly reduces the time required for physicians to review capsule endoscopy examinations (median time of 172 seconds).
  • Cost-effective technology, saving valuable resources and time.
  • Decreased risk of overlooking clinically relevant lesions.
  • Aids in identifying and differentiating lesions in the small bowel mucosa, with particular importance in suspected middle gastrointestinal bleeding, inflammatory bowel disease, and digestive oncology.
  • Multi-device interoperability, validated with full-length videos from various capsule endoscopy devices.

Limitations

  • Lower positive predictive value in suspected Crohn's Disease (CD) cohorts due to a higher rate of false positives.
  • False positives primarily attributed to poor visualization, bowel contents, bubbles, and non-erosive inflammatory findings.
  • Not intended to replace clinical decision-making.
  • Contraindicated for use in CapE exams that failed to reach the small bowel, did not record any small bowel segment, or when good bowel cleansing was not achieved.
  • The algorithm was not trained on data from pregnant women or children, so it should not be used in these demographics.
  • Capsule networks, in general, may have higher computational costs and do not always scale well to very deep architectures.

Based on reviews from: Mentoring In IBD, DigestAID, Coherent Market Insights, IEEE Computer Society, MDPI, FDA

Last updated: 2026-08-19

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Videos

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Frequently Asked Questions

Deep Capsule is an AI-powered diagnostic tool designed to analyze images from capsule endoscopy procedures. It assists gastroenterologists by identifying and characterizing abnormalities in the small bowel, potentially improving the detection of conditions like bleeding, inflammation, and polyps.
Deep Capsule is designed with robust security features and protocols to ensure compliance with patient data privacy regulations such as HIPAA. Data is typically de-identified and encrypted during transmission and analysis, and access is restricted to authorized personnel. Specific implementation details would be provided by the vendor to ensure a compliant workflow within a clinical setting.
Currently, several other AI-powered platforms and software solutions are emerging in the field of capsule endoscopy analysis. These alternatives often leverage different AI algorithms and may offer varying features, such as real-time analysis capabilities or integration with specific endoscopy systems.
The pricing model for Deep Capsule can vary, often involving a per-study fee, a subscription model, or a combination thereof. Regarding insurance coverage, it's important to verify with individual payers as reimbursement for AI-assisted diagnostic tools is an evolving area. Providers should consult with the vendor and insurance companies for specific coverage details.
While highly effective, Deep Capsule, like all AI tools, has limitations. These can include potential for false positives or negatives, challenges with image quality variations, and the inability to perform therapeutic interventions. It's crucial to remember that Deep Capsule is a decision-support tool and does not replace the expertise and final interpretation of a gastroenterologist.
Deep Capsule is typically designed to integrate with existing EHR systems through various methods, such as standard APIs or custom interfaces. This allows for seamless transfer of patient data, capsule endoscopy reports, and AI-generated findings directly into the patient's medical record, streamlining workflow and documentation.
While Deep Capsule aims for user-friendliness, some training is generally recommended for gastroenterologists and their staff. This training typically covers navigating the software interface, understanding the AI's output, troubleshooting common issues, and integrating the tool into existing clinical workflows. The vendor usually provides comprehensive training programs and support.

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Suggest an Edit → | Last Verified: 2026-08-19 | First Added: 2026-08-19
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