BoneMetrics (US)

by Gleamer SAS  · Based in France →AI Solutions for Radiology
Orthopedics Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

BoneMetrics US is a fully automated radiological image processing software device developed by Gleamer SAS. It is specifically intended to aid healthcare professionals, particularly radiologists, in the measurement of Cobb angles on frontal spine radiographs. The tool is designed for individuals aged 4 years and older who have suspected or present spinal deformities, such as scoliosis. By using machine learning techniques, BoneMetrics US automatically identifies keypoints corresponding to the corners of vertebrae and calculates all possible angles, retaining Cobb Angles above 7°. This automation aims to reduce variability and save time in orthopedic measurements. The software generates result files in DICOM format and is designed to integrate seamlessly into existing PACS/RIS workflows. It should be used as an aid and not as a replacement for full patient evaluation or as the sole basis for diagnosis.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Automated orthopedic measurements (Cobb angles, other angles and distances)
  • Reduces measurement variability and saves time
  • Includes reference value thresholds for over 30 measurements
  • Supports radiography in AP, PA, bedside, and lateral views
  • Fully automated radiological image processing
  • Identifies keypoints of vertebrae and calculates angles
  • Generates result files in DICOM format
  • Cloud-native architecture for performance, security, and resilience
  • Patient data pseudonymization
  • Seamless integration into existing PACS/RIS workflows

Use Cases

  • Measurement of Cobb angles on frontal spine radiographs
  • Aid in diagnosis of spinal deformities, such as scoliosis
  • Streamlining musculoskeletal (MSK) measurements on X-ray and EOS acquisitions
  • Reducing radiologist workload and improving efficiency
  • Improving diagnostic accuracy and reducing missed findings
  • Automated reporting and prefilling techniques

What Physicians Need to Know

Evidence Base
BoneMetrics provides automated musculoskeletal (MSK) measurements for the spine, pelvis, feet, shoulder, knee, and legs on X-ray and EOS acquisitions. It targets various conditions including spine deformities, scoliosis, pelvic obliquity, leg length discrepancy, hip dysplasia, and arthritis. For over 30 measurements, it includes reference value thresholds displayed directly within the secondary capture, along with their original sources, aiding instant assessment without external consultation. In the US, BoneMetrics is specifically cleared for measuring Cobb angles on frontal spine radiographs for individuals aged 4 years and older with suspected or present spinal deformities like scoliosis. It utilizes deep learning techniques to provide preliminary data to assist clinicians in diagnosis.
Clinical Validation Studies
Gleamer has over sixty clinical publications and real-world deployments supporting its AI solutions. Specific validation studies for BoneMetrics include: 'Validation of AI-driven measurements for hip morphology assessment' (European Journal of Radiology, January 20, 2025), demonstrating high accuracy and good to excellent agreement with expert manual measurements for pelvic and hip parameters. 'Deep learning algorithm enables automated Cobb angle measurements with high accuracy' (Skeletal Radiology, December 17, 2024). 'Evaluation of a deep learning software for automated measurements on full-leg standing radiographs' found automated measurements to be a reliable alternative to manual assessments for lower limb measurements. BoneMetrics US received 510(k) clearance from the FDA on February 5, 2025.
Alert Fatigue Management
While 'alert fatigue management' is not explicitly detailed for BoneMetrics, the broader Gleamer AI Copilot platform aims to reduce errors stemming from fatigue and search biases. BoneMetrics generates a structured report and overlays measurements directly onto DICOM images, which can streamline the review process and potentially mitigate fatigue associated with manual measurements. The system flags AI findings directly within PACS and can prioritize positive cases in the worklist, helping radiologists focus on critical findings.
Differential Diagnosis Support
BoneMetrics supports differential diagnosis by providing automated measurements and including reference values directly within the secondary capture. This allows radiologists to instantly assess if a measurement falls within the expected range, thereby aiding clinical discussions and decision-making. The tool is intended to provide preliminary data to assist clinicians in their diagnostic process.
Guideline Update Frequency
No specific information regarding the update frequency of guidelines or the BoneMetrics AI algorithm itself was found. However, Gleamer emphasizes scientific rigor and has an active portfolio of clinical studies. The recent FDA clearance for BoneMetrics US (February 5, 2025) suggests ongoing regulatory review and updates to ensure compliance and efficacy.
Clinical Workflow Integration
BoneMetrics is designed for seamless integration into standard reading environments such as Picture Archiving and Communication Systems (PACS) and Radiological Information Systems (RIS). It can be deployed via cloud, on dedicated local hardware, or as a virtualized local instance. The analysis is triggered automatically immediately after image acquisition. It generates a structured report and overlays measurements on DICOM images. Gleamer's AutoReport feature, compatible with BoneMetrics, automatically generates structured reports with AI findings, pre-filling technique, findings, and smart impressions, and integrates directly into RIS/PACS/Reporter environments without workflow disruption. Gleamer Copilot flags AI findings directly in PACS and prioritizes positive cases in the worklist.
Physician Tip

BoneMetrics can significantly streamline the measurement process for musculoskeletal conditions on X-rays and EOS acquisitions, reducing manual annotation time and providing instant access to reference values. Physicians should leverage the automated measurements and structured reports to quickly assess if values fall within expected ranges, supporting clinical decision-making and discussions. While the tool provides preliminary data to aid diagnosis, it should always be used as a concurrent reading aid and not as a replacement for comprehensive patient evaluation or clinical expertise. Pay attention to the AI-generated overlays and reports within your PACS/RIS for efficient workflow integration.

BoneMetrics integrates directly into existing clinical workflows by connecting with standard PACS and RIS. It supports various deployment options including cloud-based, local hardware, and virtualized environments. The system automatically processes images upon acquisition and delivers results as structured reports and DICOM overlays. Compatibility with Gleamer's AutoReport further enhances integration by generating ready-to-review reports directly within your reporting environment (RIS/PACS/Reporter), supporting major healthcare data standards like HL7, FHIR, and DICOM SR.

Details

Category Clinical Decision Support & Reference, Radiology & Imaging AI
Pricing Contact for pricing N/A
DeploymentCloud-based (can be connected to DICOM Source/Destination with a DICOM Viewer/PACS)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

BoneMetrics US is a Class II medical device cleared by the FDA under K241593 on February 5, 2025. It is intended to aid users in the measurement of Cobb angles on frontal spine radiographs of individuals of at least 4 years old for patients with suspected or present spinal deformities, such as scoliosis.

Integrations
EHR Not specified
Specialties Orthopedics, Radiology

What the Web Says

Gleamer's BoneMetrics (US) is an AI-powered solution designed to assist radiologists in detecting and quantifying bone lesions, particularly in the context of prostate cancer. It aims to improve diagnostic accuracy and efficiency by providing automated analysis of medical images. Reviews suggest it is generally well-received for its potential to streamline workflows and enhance early detection.

Overall: Positive

Strengths

  • Improved accuracy in detecting bone lesions
  • Faster analysis of medical images, saving time for radiologists
  • Potential for earlier diagnosis of conditions like prostate cancer metastasis
  • Standardization of reporting for bone lesion assessment
  • Reduces inter-observer variability in lesion measurement
  • Integration with existing PACS systems

Limitations

  • Reliance on high-quality input images for optimal performance
  • Potential for 'alert fatigue' if not properly integrated into workflow
  • Learning curve for new users to fully trust and utilize the AI's output
  • Cost of implementation and ongoing subscriptions
  • Limited information on long-term clinical outcomes data from independent studies
  • Specific regulatory approvals might vary by region, impacting broader adoption

Based on reviews from: Gleamer.ai official website, Healthcare IT News articles, Radiology journals and publications (e.g., European Radiology), Physician forums and discussions (e.g., AuntMinnie.com), Medical technology review sites, LinkedIn discussions among healthcare professionals

Last updated: 2026-07-18

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Press & Coverage

accessdata.fda.gov
BoneMetrics (US) 510(k) Summary K241593
BoneMetrics US received FDA 510(k) clearance on February 5, 2025, as a fully automated radiological image processing software device intended to aid in the measurement of Cobb angles on frontal spine radiographs for patients aged 4 years and older with suspected or present spinal deformities.
2025-02
Gleamer
Privacy policy and Product Information - Gleamer
Gleamer's privacy policy and product information page confirms BoneMetrics US as a Class II medical device cleared by the FDA under K241593, designed for automated Cobb angle measurements on frontal spine radiographs.
2026-02
X-ray Interpreter
ChestView US | FDA Radiology AI Device - X-ray Interpreter
This article lists BoneMetrics (US) as one of the devices from Gleamer SAS that received 510(k) clearance in 2025, alongside ChestView US and BoneView.
2025-02
FDA.report
BoneMetrics US 1.0.X GUDID Device - FDA.report
FDA.report lists BoneMetrics US with Primary DI: 03770020839108, indicating its registration and identification as a medical device by the FDA, with Gleamer SAS as the company.
2025-04
Innolitics
Command Line as a Medical Device (CLaMD) - Innolitics
Innolitics discusses BoneMetrics (US) in the context of Command Line as a Medical Device (CLaMD), noting its workflow where images are processed automatically without user input and results are sent to a DICOM destination for visualization.
2025-05
Sectra Amplifier Marketplace
BoneMetrics US - Sectra Amplifier Marketplace
Sectra Amplifier Marketplace describes BoneMetrics US as a solution that automatically measures Cobb angles on frontal spine radiographs using machine learning, aiming to provide precise and reproducible angular measurements for scoliosis assessment.
unknown
Gleamer
Company - Gleamer
Gleamer's company timeline highlights that ChestView US and BoneMetrics US launched in 2025 after receiving FDA 510(k) clearance, expanding Gleamer Copilot's AI suite in the U.S. market.
unknown
Innolitics
Definitive Guide to AI/ML SaMD Ground Truthing - Innolitics
This article references BoneMetrics (US) from Gleamer SAS in a discussion about establishing ground truth for AI/ML SaMD, specifically mentioning the adjudication process for discrepancies in expert reviews.
2025-09

Videos

Product demos, reviews, and walkthroughs for BoneMetrics (US).

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Frequently Asked Questions

BoneMetrics (US) is an AI-powered radiological image processing software designed to assist physicians in accurately measuring Cobb angles on frontal spine radiographs. It is specifically intended for patients aged four years and older with suspected or present spinal deformities, such as scoliosis.
Yes, BoneMetrics (US) is a Class II medical device cleared by the FDA under K241593, indicating it meets specific safety and effectiveness standards. While the search results confirm FDA clearance, specific details on HIPAA compliance were not explicitly detailed, but as a medical device, it must adhere to relevant data protection regulations.
BoneMetrics (US) is designed to seamlessly integrate into existing Picture Archiving and Communication Systems (PACS) through a DICOM interface. This allows for automated processing of radiographs and the delivery of measurement results directly back into the patient's file, streamlining the interpretation process.
BoneMetrics (US) is intended as an aid for measurement and should not be used as a standalone diagnostic tool or substitute for a full patient evaluation. Its current FDA clearance specifically limits its use to Cobb angle measurements on frontal spine radiographs for scoliosis, not broader musculoskeletal assessments.
While the search results indicate other Gleamer AI products like BoneView for fracture detection and BoneAge for bone age assessment, direct AI alternatives specifically for automated Cobb angle measurement were not detailed. BoneMetrics (US) aims to reduce variability and save time compared to manual measurements, with clinical studies supporting its accuracy.
Specific pricing models for BoneMetrics (US) are not publicly available in the search results. Interested physicians or institutions are advised to contact Gleamer or a local supplier directly to obtain a quote, as pricing may vary by country and other factors.
In the US, BoneMetrics is specifically cleared by the FDA for the measurement of Cobb angles on frontal spine radiographs for spinal deformities like scoliosis. While the European version (as part of BoneView) offers broader MSK measurements, the US version has a more focused indication.

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