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
The brAInu2122 Shoulder Positioning software is designed to accept patient's shoulder CT-scan data in DICOM series format.
PACS Integration Method
brAInu2122 Shoulder Positioning is an AI-powered, cloud-based planning platform. Cloud-based solutions generally integrate with PACS through standard protocols for data exchange, such as DICOM.
Reading Room Workflow Impact
The tool aims to enhance surgical outcomes and simplify the preoperative workflow by providing high-resolution 3D visuals for deeper insights and more precise surgical planning. It enables surgeons to simulate and optimize shoulder implant positioning before surgery. Features include automatic segmentation, as well as humeral and glenoid planning.
AI Model Architecture (deep learning approach)
The software leverages artificial intelligence to provide detailed images of soft tissues and is designed to improve over time by learning from processed data. Its AI algorithm automatically computes humerus and scapula segmentation. The automatic segmentation was validated against manual segmentation, achieving a Dice Similarity Coefficient (DSC) of 0.95 or higher. Deep learning segmentation models are utilized for shoulder joint anatomy.
Processing Speed (per study)
Algorithms automatically generate a 3D model from imaging data in seconds.
FDA Clearance Pathway (510k/De Novo)
brAInu2122 Shoulder Positioning has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). Multiple 510(k) clearances are listed, including K252665 (cleared October 20, 2025) and K243292 (cleared March 20, 2025). It is classified as a 'System, Image Processing, Radiological' (Product Code QIH or LLZ) and is considered a non-high-risk device under the AI Act.
Supported Modalities (CT/MRI/X-ray/US)
The software is intended for use with patient shoulder CT-scans (DICOM series). Avatar Medical's broader technology also converts 2D medical images such as MRIs and CT scans into 3D.
Sensitivity & Specificity Data
The automatic segmentation achieved a Dice Similarity Coefficient (DSC) of 0.95 or higher when validated against manual segmentation. Validation of correct shoulder side detection and measurement accuracy were successfully completed. Landmark performance testing achieved accuracy similar to manual positioning with a 3 mm mean distance.
RSNA/ACR Validation
While Avatar Medical participates in discussions and events related to radiology and patient understanding (e.g., RSNA), there is no explicit statement of direct validation by RSNA or ACR for the brAInu2122 Shoulder Positioning tool itself. However, Avatar Medical has FDA-cleared devices listed on the ACR Data Science Institute's AI Central.
Physician Tip

Leverage brAInu2122 Shoulder Positioning for comprehensive preoperative planning, especially for complex shoulder arthroplasty cases, to visualize soft tissue impact and optimize implant placement. The 3D visualization and automatic segmentation can significantly enhance understanding of patient-specific anatomy, potentially leading to more precise surgical strategies and improved patient outcomes. Integrate this tool early in your planning workflow to simulate different scenarios and refine your approach before entering the operating room.

As a cloud-based solution, brAInu2122 Shoulder Positioning is designed for seamless integration with existing hospital systems that support DICOM standards for image upload. Ensure your PACS infrastructure allows for efficient and secure transfer of CT DICOM series to the cloud platform. Compatibility with web-based interfaces and adherence to cybersecurity protocols are key for optimal performance and data integrity.

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Unknown
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Cleared AI-estimated

brAIn™ Shoulder Positioning received 510(k) clearance (K252665) from the U.S. Food and Drug Administration (FDA) 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.
Integrations
EHR Not specified
Specialties Orthopedics, Radiology

What the Web Says

brAIn Shoulder Positioning by Avatar Medical is an AI-powered, cloud-based surgical planning solution developed in partnership with FX Shoulder Solutions. It aims to transform shoulder arthroplasty by providing orthopedic surgeons with real-time 3D visualizations to simulate and optimize implant positioning preoperatively. The platform is designed to enhance surgical outcomes, streamline workflows, and improve communication between physicians and patients by allowing them to collaboratively review 3D anatomical models derived from CT and MRI scans.

Overall: Mixed

Strengths

  • AI-powered, real-time 3D visualizations for surgical planning.
  • Enables simulation and optimization of implant positioning preoperatively.
  • Aims to enhance surgical outcomes and streamline preoperative workflows.
  • Improves physician-patient communication through shared 3D anatomical understanding.
  • Integrates into existing clinical workflows and PACS.
  • FDA clearance anticipated in mid-2025.

Limitations

  • Limited public reviews currently available due to recent market entry and anticipated FDA clearance.
  • Specific pricing information is not readily available in the search results.
  • No detailed feedback from Reddit, G2, or Capterra found yet.

Last updated: 2026-07-17

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Press & Coverage

Avatar Medical
Avatar Medical Partners with FX Shoulder Solutions: Transforming Surgical Planning in Shoulder Arthroplasty
Avatar Medical has partnered with FX Shoulder Solutions to launch brAIn Shoulder Positioning, an AI-powered solution for surgical planning in shoulder arthroplasty, combining precision implants with real-time 3D visualizations. This collaboration aims to enhance surgical outcomes and streamline preoperative workflows, with FDA clearance anticipated in mid-2025.
2024-11
PharmaShots
Avatar Medical & FX Shoulder Solutions Reports the US FDA's 510(k) Clearance of brAIn Shoulder Positioning System (SPS) for Arthroscopic Surgeries
The US FDA has granted 510(k) clearance to brAIn Shoulder Positioning System (SPS) for preoperative planning and implant placement in shoulder surgery. This system, developed by FX Shoulder Solutions and Avatar Medical, utilizes AI-driven imaging and 3D avatar visualization for precise soft tissue assessment.
2025-03
HealthAidb
brAInu2122 Shoulder Positioning | Avatar Medical radiology AI profile
brAInu2122 Shoulder Positioning is an FDA-cleared radiology AI listing for CT/CTA, providing a profile with FDA source links, workflow fields, and buyer-fit notes.
unknown
Innolitics
2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances - Innolitics
This comprehensive analysis of 2025 cardiology AI/ML clearances includes Avatar Medical's brAIn Shoulder Positioning, which received a traditional 510(k) clearance for radiology on October 20, 2025.
2026-01
Nyquist AI Blog
Data Update: November 2025 - Nyquist AI Blog
This data update keeps readers informed on FDA device approvals, regulatory updates, and emerging adverse event trends, mentioning brAIn Shoulder Positioning.
2025-11
Datanyze
What is Sales and Marketing Strategy of AVATAR MEDICAL ...
Avatar Medical's sales and marketing strategy includes its 'brAIn Shoulder Positioning' solution, a collaboration with FX Shoulder Solutions that combines implants with 3D visualizations and AI for surgical planning.
2025-07
Avatar Medical
brAIn Shoulder Positioning - Avatar Medical
brAInu2122 Shoulder Positioning is a partnered solution for surgical planning in shoulder arthroplasty, co-developed by Avatar Medical and FX Shoulder Solutions, with FDA and CE documentation available.
2026

Videos

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

View all on YouTube

Frequently Asked Questions

brAInu2122 Shoulder Positioning is designed as a cloud-based application that integrates with existing imaging systems by allowing surgeons to upload patient CT scans (DICOM series) for automatic segmentation and 3D reconstruction of shoulder anatomy. This enables preoperative planning and visualization of implant positioning, aiming to enhance surgical outcomes and streamline the workflow.
brAInu2122 Shoulder Positioning has received 510(k) clearance from the FDA, indicating it is deemed safe and effective for its intended use in preoperative surgical planning and visualization for primary total shoulder replacement. The system ensures patient data privacy through secure cloud-based operations and adherence to regulations like HIPAA, with a focus on data security and safe data sharing.
Current best practices often involve traditional preoperative planning tools focusing on bone structures, 2D CT scans, or patient-specific instrumentation. brAInu2122 Shoulder Positioning differentiates itself by integrating AI-driven imaging to provide an unprecedented view of soft tissues, which is critical for proper implant positioning and long-term joint function. This allows for more informed decisions, improved accuracy, and enhanced patient recovery compared to traditional methods.
While specific pricing details like subscription or per-use fees for brAInu2122 Shoulder Positioning are not publicly available, similar advanced orthopedic technologies often involve a combination of software licensing and potentially per-case fees. Reimbursement for new technologies in orthopedics can be complex, with some procedures potentially eligible for New Technology Add-on Payments (NTAP) from Medicare, though this varies by technology and specific case.
Like many AI systems, brAInu2122 Shoulder Positioning's effectiveness can be influenced by data limitations, such as the quality and availability of training data, which might impact its performance in highly complex or unusual anatomical variations. While it offers advanced 3D visualization and planning, surgeons must still exercise clinical judgment, as AI tools are intended to support, not dictate, care.
The software's automatic segmentation and measurement capabilities have been validated against manual segmentation, meeting acceptance criteria with high accuracy. Clinical evidence suggests AI-powered tools can enhance injection accuracy and improve patient outcomes in shoulder-related procedures. However, ongoing research and external validation across diverse patient populations are crucial for further establishing broad efficacy.
brAInu2122 Shoulder Positioning is designed as a decision support tool, meaning the surgeon remains in control and can override AI recommendations based on their clinical judgment. The system aims to provide insights and data-driven recommendations, but ultimately, the final decision-making authority rests with the physician, especially in complex or unusual cases.

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