brAIn Shoulder Positioning

by Avatar Medical  · Based in France → — Surgical Planning for Shoulder Arthroplasty Co-developed by Avatar Medical and FX Shoulder Solutions
Orthopedics Radiology
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Regulatory Status Disclosed

Overview

brAIn™ Shoulder Positioning is a cutting-edge, AI-powered, cloud-based surgery planning solution developed through a collaboration between Avatar Medical and FX Shoulder Solutions. It combines state-of-the-art imaging with advanced AI algorithms for preoperative planning and implant placement in shoulder surgery. Unlike traditional preoperative planning tools that focus solely on bone structures, brAIn™ Shoulder Positioning integrates AI-driven imaging to provide an unprecedented view of soft tissues—a critical factor in ensuring proper implant positioning and long-term joint function. This one-of-a-kind capability enables surgeons to develop more precise and effective surgical strategies, ultimately aiming to improve patient outcomes. The software features automatic segmentation, humeral and glenoid planning, and can allow surgeons to gain insights on the potential impact of implant positioning on the soft tissues. Accessible via a web-based interface, users can upload patient CT-scan (DICOM series) data. The system automatically segments and performs measurements on scapula and humerus anatomy for planning with an interactive 3D viewer. The software outputs a planning multimodal summary that includes textual information (patient information, pre- and post-op measurements) and visual information (screen captures of the shoulder pre- and post-implantation).

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered, cloud-based surgical planning
  • 3D avatar visualization technology
  • Automatic segmentation of anatomy
  • Humeral and glenoid planning
  • Soft tissue visualization
  • Preoperative planning and implant placement
  • Interactive 3D viewer
  • Web-based interface for CT-scan (DICOM series) upload
  • Multimodal planning summary output
  • Assists in planning primary anatomic and reverse total shoulder replacement surgeries

Use Cases

  • Preoperative planning for shoulder arthroplasty
  • Implant placement in shoulder surgery
  • Enhanced surgeon-patient communication
  • Medical training and research
  • Improving physician collaboration

What Physicians Need to Know

DICOM Support & Standards
brAIn Shoulder Positioning is a cloud-based application that prompts users to upload patient CT-scan DICOM series. The automatic segmentation provided by brAIn™ Shoulder Positioning was validated against manual segmentation using a dataset of 508 pairs of 3D images (DICOM series).
PACS Integration Method
The integration of AI into PACS has significantly enhanced diagnostic accuracy and workflow efficiency. Cloud-based solutions have improved accessibility, enabling real-time collaboration and remote diagnostics. Avatar Medical's solutions integrate seamlessly into existing clinical workflows, and the company has announced an Epic integration to bring its tools directly into the physician's standard workflow.
Reading Room Workflow Impact
brAIn Shoulder Positioning is designed to enhance preoperative planning for shoulder arthroplasty by providing 3D visualization of patient-specific anatomy, including soft tissues. This allows surgeons to make more informed decisions, leading to improved accuracy, better surgical planning, and enhanced patient recovery. The cloud-based platform allows for real-time 3D rendering without the need for local installation, enhancing accessibility and enabling surgeons to plan surgeries from anywhere, anytime. The technology converts standard CT and MRI scans into interactive 3D models automatically without requiring manual segmentation, which allows for real-time visualization during surgical planning and clinical reviews. This integration simplifies the workflow by eliminating the need to switch between disparate software platforms and can reduce the time required for doctors to review complex diagnostic imaging during consultations.
AI Model Architecture (deep learning approach)
brAIn Shoulder Positioning utilizes AI-powered automatic segmentation of humeral and glenoid structures and integrates AI-driven imaging to provide detailed images of soft tissues. The system is designed to improve over time by learning from the data it processes. Deep learning segmentation models, such as nnUNet and U-Net, play a crucial role in segmenting key anatomical subregions of the shoulder joint, achieving high efficiency and stable performance. These models can automatically adapt to different datasets and tasks, learning from large volumes of shoulder joint image data.
FDA Clearance Pathway (510k/De Novo)
brAIn™ Shoulder Positioning received FDA 510(k) clearance (K252665) on October 20, 2025. It is intended to be used as an information tool to assist in the preoperative surgical planning and visualization of a primary total shoulder replacement. The device was determined to be substantially equivalent to a predicate device.
Supported Modalities (CT/MRI/X-ray/US)
brAIn Shoulder Positioning processes CT and MR images. The software prompts users to upload patient CT-scan DICOM series. Avatar Medical's core technology converts CT and MRI scans into interactive, photorealistic 3D models.
Sensitivity & Specificity Data
The automatic segmentation provided by brAIn™ Shoulder Positioning was validated against manual segmentation, achieving a Dice Similarity Coefficient (DSC) of ≥0.95 on a diverse dataset of 508 3D CT volumes. This demonstrates that the segmentation produced by the model closely matches the ground truth. In other AI applications for shoulder imaging, ultrasound has shown a sensitivity of 94% and a specificity of 93% in detecting full-thickness rotator cuff tears. Convolutional neural networks (CNNs) have demonstrated up to 94% accuracy in image segmentation.
RSNA/ACR Validation
Avatar Medical has participated in RSNA events, with articles discussing topics like bridging radiology and patient understanding. However, specific RSNA/ACR validation for brAIn Shoulder Positioning is not explicitly mentioned.
Physician Tip

brAIn Shoulder Positioning offers significant advantages for preoperative planning in shoulder arthroplasty by providing AI-powered automatic segmentation of humeral and glenoid structures and 3D soft tissue visualization. This can lead to more informed decisions, improved implant positioning accuracy, and potentially better patient outcomes. The cloud-based nature of the platform allows for flexible access and real-time 3D rendering, streamlining the surgical planning workflow. Pay close attention to the detailed soft tissue visualization, as this is a key differentiator from traditional bone-focused planning tools. The system's ability to learn from data suggests continuous improvement in its capabilities.

The brAIn Shoulder Positioning solution is co-developed by Avatar Medical and FX Shoulder Solutions, and it is exclusively utilized by FX Shoulder Solutions. It integrates with FX Shoulder Solutions implant systems. Avatar Medical's broader solutions are designed for seamless workflow integration with PACS and EMR systems, and a recent Epic integration aims to further streamline access to its 3D visualization tools within existing hospital frameworks.

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Unknown
Compliance
BAA AvailableUnknown
HIPAA CompliantUnknown
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Orthopedics, Radiology

What the Web Says

brAIn Shoulder Positioning, developed by Avatar Medical in partnership with FX Shoulder Solutions, is an AI-powered, cloud-based surgical planning solution designed to enhance preoperative planning for primary total shoulder replacement. It provides 3D visualization of patient-specific shoulder anatomy, including soft tissues, to improve implant positioning and surgical precision. The system is FDA-cleared and aims to streamline workflows and improve patient outcomes.

Overall: Positive

Strengths

  • Revolutionizes preoperative planning with unparalleled 3D visualization of soft tissues.
  • AI-driven automatic segmentation significantly improves surgical planning efficiency.
  • Cloud-based deployment allows for surgical planning from anywhere, streamlining workflow.
  • Integrates soft tissue visualization with bone structures, leading to better patient outcomes.
  • Intuitive interface makes it easy for surgical teams to adopt and utilize effectively.
  • FDA-cleared, ensuring compliance with medical device standards and reliability.

Limitations

No significant limitations found in public reviews. Consider checking vendor documentation or requesting a demo for a thorough evaluation.

Based on reviews from: healthaidb.com, parikhradiology.com, rasph.com, avatarmedical.ai, innolitics.com

Last updated: 2026-10-29

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Press & Coverage

healthcareaiops.com
FDA 510(k) K252665: brAIn™ Shoulder Positioning by Avatar Medical, cleared 2025-10-20 under AI-associated product code QIH
brAIn™ Shoulder Positioning by Avatar Medical received FDA 510(k) clearance on October 20, 2025, under the AI-associated product code QIH.
2026-08
innolitics.com
Comprehensive analysis of 2025 cardiology AI/ML clearances, market trends, capital events, and regulatory insights
An analysis of 2025 AI/ML clearances in cardiology mentions Avatar Medical's brAIn Shoulder Positioning receiving FDA clearance (K252665) on October 20, 2025.
2026-01
nyquistai.com
FDA device approvals, regulatory updates, and emerging adverse event trends
brAIn Shoulder Positioning was noted in a November 2025 update on FDA device approvals and regulatory trends, with its product code QIH in Radiology.
2025-11
healthaidb.com
brAIn Shoulder Positioning
brAIn Shoulder Positioning is an AI-powered, cloud-based surgical planning solution co-developed by Avatar Medical and FX Shoulder Solutions, designed to enhance preoperative planning for shoulder arthroplasty by providing 3D visualization of patient-specific anatomy, including soft tissues.
2025-10
avatarmedical.ai
Partnered Solution brAIn™ Shoulder Positioning
brAIn™ Shoulder Positioning is a surgical planning solution for shoulder arthroplasty co-developed by Avatar Medical and FX Shoulder Solutions, with available FDA and CE documentation.
unknown
rasph.com
Avatar Medical: EIC-backed surgical imaging firm wins FDA clearance and hospital deployments
Avatar Medical completed its shoulder replacement planning platform, "brAIn Shoulder Positioning," which received FDA clearance and is now commercialized in the USA through a partnership with FX Shoulder.
2026-09
avatarmedical.ai
Avatar Medical Partners with FX Shoulder Solutions: Transforming Surgical Planning in Shoulder Arthroplasty
Avatar Medical partnered with FX Shoulder Solutions to launch brAIn Shoulder Positioning, a surgical planning solution combining precision implants with AI-powered, real-time 3D visualizations, with FDA clearance anticipated in mid-2025.
2024-11
avatarmedical.ai
Partnered Solution brAIn™ Shoulder Positioning (Research Use Only)
brAIn™ Shoulder Positioning is also available as a Research Use Only (RUO) solution for surgical planning in shoulder arthroplasty, co-developed by Avatar Medical and FX Shoulder Solutions.
unknown

Videos

Product demos, reviews, and walkthroughs for brAIn Shoulder Positioning.

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Frequently Asked Questions

brAIn Shoulder Positioning is an AI-powered, cloud-based surgical planning solution that provides detailed 3D visualizations of both bone and soft tissues from CT scans. This allows surgeons to better understand how implant placement could affect surrounding tissues, leading to more precise surgical procedures and potentially improved patient outcomes.
brAIn Shoulder Positioning has received FDA 510(k) clearance (K252665) and is cleared under the AI-associated product code QIH. It conforms to FDA guidance and IEC 62304 standards, ensuring its reliability and safety for medical use.
While brAIn Shoulder Positioning offers advanced AI-driven 3D visualization of soft tissues, traditional preoperative planning tools often focus primarily on bone structures. Other AI tools are emerging that can segment and provide 3D views of shoulder bones from MRI scans, potentially reducing the need for CT scans. Ultrasound imaging is also used for shoulder diagnosis and can be enhanced with AI for improved accuracy and path planning for injections.
While brAIn Shoulder Positioning offers significant advantages in visualization and planning, specific limitations within a radiology workflow are not explicitly detailed. However, general challenges in shoulder imaging can include patient discomfort or inability to maintain specific positions for imaging, which can affect image quality and subsequent AI analysis.
brAIn Shoulder Positioning operates on a subscription pricing model. Specific pricing details for healthcare providers are not publicly available, but it is accessible via a free trial on Avatar Medical's website.

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-17 | First Added: 2026-04-17
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