FDA Radiology AI Devices

ARVIS® Shoulder is a computer-assisted surgical navigation system designed to help surgeons precisely position and align implants during total shoulder arthroplasty. It uses preoperative CT scans processed with AI algorithms for automatic image segmentation and anatomical landmark identification, providing real-time measurements during surgery to guide instrument placement and implant positioning, thereby enhancing surgical accuracy and outcomes.

Preview Shoulder is a software tool designed to help orthopedic surgeons plan shoulder surgery using 3D models created from CT scans. It allows surgeons to place digital implants within the shoulder anatomy and generate detailed surgical plans to improve surgical outcomes. This software is used as a pre-operative planning aid and is intended for adult patients only, not for diagnostic purposes.

Automatic Registration by Brainlab AG is a software tool that facilitates image-guided surgery by automatically registering intraoperatively acquired 3D CT, CBCT, or fluoroscopic images to the surgical environment. This helps surgeons precisely correlate patient images with their anatomy during surgery, improving navigation accuracy and surgical outcomes.

OTS Hip is a surgical system designed to assist orthopedic surgeons in planning and performing total hip arthroplasty (hip joint replacement) surgeries. It uses CT images of the patient's hip anatomy to create a detailed 3D model, enabling precise preoperative planning and real-time intraoperative navigation. This image-guided system improves surgical accuracy and helps position compatible hip prostheses according to the pre-planned locations, enhancing patient outcomes.

BoneMRI is an AI-powered software that enhances MRI images to better visualize bone structures in the pelvic and spine regions. It improves the contrast of bone relative to soft tissue to assist radiologists and orthopedic surgeons in assessing bone morphology and tissue radiodensity without replacing CT imaging. It supports clinical use in patients aged 12 and older and operates via hospital networks, ensuring data security.

VEA Align is a cloud-based software developed by EOS imaging that uses 2D X-ray images acquired from EOS imaging systems to assist healthcare professionals in assessing global alignment in orthopedic patients. It applies machine learning algorithms to automatically place anatomical landmarks on images, helping clinicians analyze spinal deformities, degenerative diseases, and lower limb disorders with precise angle and length measurements. It supports both pediatric and adult patients and enhances clinical decision-making through interactive landmark adjustment and comparison to normative values.

The United Orthopedic Knee Patient Specific Instrumentation by Enhatch, Inc. is a system that uses AI-powered software to process CT and X-ray images for 3D modeling and preoperative surgical planning of total knee arthroplasty. It includes patient-specific surgical guides to help orthopedic surgeons accurately position knee implants during surgery, improving precision and outcomes for patients without severe bone deformities.

Bonelogic is a software used by orthopedic healthcare professionals to assist in diagnosis and surgical planning of foot and ankle conditions using CT scan data. It provides semi-automatic segmentation of bones, creates 3D models, and offers measurement tools to support clinical decision-making and treatment planning.

Axial3D Insight is a cloud-based image segmentation and 3D modeling service that converts medical imaging data into digital files or 3D printed physical models. These outputs assist clinicians in treatment planning and diagnosis for trauma, orthopedic, maxillofacial, and cardiovascular conditions, improving clinical decision-making.

aprevo® Digital Segmentation is a software tool designed for trained medical personnel to process medical images of the spine, specifically the lumbar area. It uses AI algorithms to automatically segment the spine from DICOM images and generates a 3D model, aiding in clinical planning or design tasks related to spine anatomy.