ChestView US

by Gleamer SAS  · Based in France → — AI Copilot for Radiologists: Enhancing Diagnostic Accuracy in Medical Imaging
Emergency Medicine Radiology
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Regulatory Status Disclosed

Overview

ChestView US by Gleamer SAS is an advanced artificial intelligence-powered Computer-Assisted Detection (CADe) software designed to assist radiologists and emergency medicine physicians in the interpretation of frontal and lateral chest X-rays. The tool leverages deep learning algorithms to automatically detect and highlight important findings, including pleural space abnormalities, lung nodules, mediastinum/hila abnormalities, and consolidation. It is intended as a concurrent reading aid, aiming to improve diagnostic sensitivity, reduce reading times, and optimize workflow. ChestView US also features automatic Cardiothoracic Ratio (CTR) measurement on posteroanterior (PA) chest X-rays for patients over 15 years old, supporting the detection of cardiomegaly. Additionally, its AutoReport feature can automatically generate patient reports based on findings, saving time and ensuring consistency. The software integrates seamlessly into existing clinical workflows, providing critical insights in seconds.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Detection and localization of pneumothorax
  • Detection and localization of pleural effusion
  • Detection and localization of consolidation
  • Detection and localization of mediastinal or hilar mass
  • Detection and localization of pulmonary nodule
  • Triage and worklist prioritization
  • Automatic Cardiothoracic Ratio (CTR) measurement
  • AutoReport generation
  • Deep learning algorithms for image analysis
  • Concurrent reading aid

Use Cases

  • Assisting radiologists in interpreting chest X-rays
  • Enhancing diagnostic accuracy for chest pathologies
  • Reducing reading times for chest radiographs
  • Prioritizing urgent cases in radiology workflows
  • Identifying early signs of lung cancer (e.g., nodules)
  • Supporting emergency medicine physicians in rapid diagnosis

What Physicians Need to Know

DICOM Support & Standards
ChestView US expects DICOM files from X-ray modalities and generates result files in DICOM format (DICOM SC), consisting of annotated images with bounding boxes around identified regions of interest.
PACS Integration Method
The solution integrates seamlessly into existing clinical workflows and standard reading environments (PACS) and RIS. It can be deployed on the cloud or locally, connecting to DICOM sources/destinations via a Gateway or AI marketplace/distribution platform.
Reading Room Workflow Impact
ChestView US acts as a concurrent reading aid, providing an automatic second reading of chest X-rays. It aims to increase diagnostic sensitivity, reduce reading time (by an average of 31%), and improve accuracy by highlighting regions of interest and automatically generating patient reports (AutoReport).
AI Model Architecture (deep learning approach)
ChestView US leverages cutting-edge artificial intelligence algorithms, specifically a deep convolutional neural network (CNN) based on the Detectron2 architecture, an open-source framework for object detection in medical images. It uses machine learning techniques to identify and produce bounding boxes around regions of interest.
Processing Speed (per study)
The processing time for ChestView is typically 10-60 seconds per study, providing critical insights rapidly.
FDA Clearance Pathway
ChestView US received 510(k) clearance from the U.S. Food and Drug Administration (FDA) under K241620 as a Class II medical device, specifically a Computer-Assisted Detection (CADe) software device for chest X-ray interpretation.
Supported Modalities
ChestView US is designed for the analysis of frontal and lateral chest radiographs (X-rays). It does not support Ultrasound.
Sensitivity & Specificity Data
Clinical studies have demonstrated improved diagnostic sensitivity and reduced time-to-diagnosis. For example, AI assistance led to an average 38.6% increase in pneumothorax detection by general radiologists, 8.5% for pleural effusion, and 14.1% for consolidation. Sensitivity for lung nodules increased by 12-18%. The device shows high AUC values for various findings (e.g., Nodule AUC 0.93, Pleural Space Abnormality AUC 0.973).
RSNA/ACR Validation
Gleamer's ChestView has been featured in publications in Radiology, the premier publication of The Radiological Society of North America (RSNA). A previous study on Gleamer's BoneView received the RSNA Alexander R. Margulis Award for Scientific Excellence.
Physician Tip

ChestView US is a valuable 'diagnostic copilot' for chest X-ray interpretation, especially in busy emergency settings or for general radiologists. Leverage its automated detection of findings like nodules, pneumothorax, and pleural effusions to enhance diagnostic accuracy and reduce reading time. The AI-generated reports can streamline documentation. Remember it's an aid, not a replacement for clinical judgment, and is currently indicated for X-ray only. Pay attention to the highlighted regions of interest and the confidence levels provided by the AI.

ChestView US is designed for seamless integration into existing PACS and RIS environments, often facilitated by a DICOM Gateway or through AI marketplaces. It supports standard healthcare data protocols like DICOM, HL7, and FHIR for reporting. Deployment options include cloud-based or local GPU server setups, ensuring flexibility for various IT infrastructures. GleamerOS provides an orchestration layer for reliable routing of studies and results.

Details

Category Radiology & Imaging AI, Triage & ER/ICU AI
Pricing Unknown
DeploymentCloud-based, Locally on dedicated hardware, Locally virtualized (virtual machine, Docker)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

ChestView US received FDA 510(k) clearance (K241620) on February 27, 2025. It is cleared as a radiological Computer-Assisted Detection (CADe) software device for analyzing frontal and lateral chest radiographs to identify and highlight regions of interest such as nodules, pleural space abnormalities, mediastinum/hila abnormalities, and consolidation.
Integrations
EHR Not specified
Specialties Emergency Medicine, Radiology

What the Web Says

Gleamer's ChestView US is an AI-powered software designed to assist radiologists and clinicians in detecting abnormalities on chest X-rays. It has received FDA 510(k) clearance and aims to improve diagnostic sensitivity, accuracy, and reduce interpretation time. Clinical studies have shown promising results, with increased detection rates for various pathologies and a significant reduction in reading time.

Overall: Positive

Strengths

  • Increases diagnostic sensitivity for abnormalities like pneumothorax, pleural effusion, consolidation, and pulmonary nodules.
  • Reduces chest X-ray reading time for radiologists and residents.
  • Enhances image interpretation accuracy.
  • Provides a computer-aided detection (CADe) model that simultaneously detects multiple pathologies and highlights abnormalities directly on images, improving explainability and confidence.
  • Seamless integration and ease of adoption for healthcare providers, especially for existing users of Gleamer's BoneView.
  • Potential to serve as a learning tool for radiology residents.

Limitations

  • The absence of harmonized and internationally standardized frameworks for AI in radiology creates legal and ethical uncertainty.
  • No specific negative reviews from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra were found for ChestView US.
  • Limited information available from independent tech reviewers or user communities like Reddit, G2, or Capterra directly pertaining to ChestView US.

Based on reviews from: PMC, Diagnostic Imaging, BioWorld, ICE Magazine, accessdata.fda.gov

Last updated: 2026-07-18

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Press & Coverage

RadAI Slice
ChestView US | FDA Radiology AI Device - X-ray Interpreter
ChestView US, an AI software product by Gleamer SAS, received FDA approval (K241620) on February 27, 2025. It analyzes frontal and lateral chest X-rays to detect and mark suspicious areas like lung nodules, pleural abnormalities, mediastinal/hilar abnormalities, and consolidations, acting as a concurrent reading aid for clinicians.
2025-02
accessdata.fda.gov
February 27, 2025 Gleamer SAS Antoine Tournier Chief Compliance Officer 47bis rue des Vinaigriers PARIS, 75010 FRANCE Re: K - accessdata.fda.gov
This FDA 510(k) summary details the clearance of ChestView US (K241620) on February 27, 2025, as a Class II radiological Computer-Assisted Detection (CADe) software device. It's intended to analyze chest radiographs for suspicious regions of interest and is for prescription use only, indicated for adults.
2025-02
Gleamer.ai
Company - Gleamer
Gleamer's company timeline indicates that ChestView US received FDA 510(k) clearance in 2025, expanding their AI suite for chest X-rays in the U.S. market. This follows the 2021 introduction of ChestView as a CE-marked AI solution for chest X-ray interpretation in Europe.
2025-02
ResearchGate
Opinion paper: artificial intelligence as a clinical ally in lung cancer detectionu2014the case for Gleamer's ChestView - ResearchGate
This opinion paper, published in October 2025, discusses Gleamer's ChestView as a computer-aided detection (CAD) solution based on artificial intelligence for chest X-ray analysis, highlighting its potential to improve diagnostic sensitivity for lung cancer. It emphasizes that ChestView acts as a diagnostic copilot, not a replacement for radiologists.
2025-10
Gleamer.ai
Privacy policy and Product Information - Gleamer
Gleamer's privacy policy and product information, updated in February 2026, confirms ChestView US is a Class II medical device cleared by the FDA under K241620. It uses machine learning to identify and label regions of interest on frontal and lateral chest radiographs.
2026-02
Sectra Amplifier Marketplace
ChestView US - Sectra Amplifier Marketplace
This marketplace listing describes ChestView US as an AI-powered Computer-Assisted Detection (CADe) software that analyzes chest radiographs to identify and highlight regions of interest. It is intended for use as concurrent reading support for symptomatic adult patients, aiming to improve detection sensitivity for urgent findings.
unknown
Innolitics
Command Line as a Medical Device (CLaMD) - Innolitics
An article from May 2025 discusses 'Command Line as a Medical Device (CLaMD)' and references Gleamer SAS's ChestView US (K241620) as an example of software that operates in the background, processing images and sending annotated DICOM files to a PACS for visualization without its own interactive GUI.
2025-05
FDA
Establishment Registration & Device Listing - FDA
The FDA's Establishment Registration & Device Listing, updated in June 2026, includes Gleamer as a contract manufacturer for 'analyzer, medical image - ChestView US' with registration number 3021907554.
2026-06

Videos

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Frequently Asked Questions

ChestView US is an AI-powered Computer-Assisted Detection (CADe) software designed to seamlessly integrate into standard reading environments like PACS and RIS. It analyzes frontal and lateral chest X-rays, automatically identifying and highlighting regions of interest for findings such as nodules, pleural space abnormalities, mediastinum/hila abnormalities, and consolidation, aiming to assist radiologists and clinicians as a concurrent reading aid.
ChestView US has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) as a Class II medical device. It is intended for prescription use only and is indicated for adults.
Clinical studies have shown that ChestView US can significantly improve diagnostic sensitivity and reduce chest X-ray reading time, with one study reporting a 31% decrease in average reading time. It has been found to increase detection rates for various abnormalities, such as pneumothorax, pleural effusion, and consolidation.
ChestView US is intended as a concurrent reading aid and does not replace the critical role of radiologists, emergency medicine physicians, or other diagnostic testing in the standard of care. It is indicated for adults only, and its performance can be affected by variable image quality in real-world clinical settings.
Gleamer, the developer of ChestView US, has a privacy policy that outlines data processing and protection measures, including a Data Protection Officer. The software generates result files in DICOM format with annotated images but does not alter the original patient images.
Yes, other AI-powered tools for chest X-ray interpretation exist, such as Azmed's Azchest. ChestView US differentiates itself as a Computer-Aided Detection (CADe) model cleared by the FDA for simultaneously detecting multiple findings and directly highlighting regions of interest, which enhances explainability and confidence compared to traditional triage-focused CADt solutions.
Specific pricing models for ChestView US are not publicly disclosed in the available information. Healthcare institutions interested in obtaining a quote or understanding the pricing structure would need to contact Gleamer directly or their authorized distributors.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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