FDA Radiology AI Devices

Acorn 3D Software is an advanced medical imaging software that processes CT and CTA scans to visualize, segment, and create detailed 3D digital models of musculoskeletal and craniomaxillofacial anatomy, including spine regions. It offers machine learning-based automatic segmentation for certain vertebrae and semi-automatic/manual tools for other bones. Clinicians can use these digital models for measurement, treatment planning, and can also produce physical 3D printed replicas for diagnostic purposes, enhancing surgical planning and patient care.

SMART Bun-Yo-Matic X-Ray is a software tool that uses X-ray images of the foot and ankle to create 3D mathematical models, provide radiographic measurements, and assist orthopedic healthcare professionals in diagnosis and surgical planning. The software visualizes patient anatomy and orthopedic fixation devices, enabling precise pre-surgical planning to improve treatment outcomes for foot and ankle conditions such as hallux valgus.

VEA Align and spineEOS are cloud-based medical imaging software products by EOS imaging designed to assist healthcare professionals. VEA Align helps assess spinal and lower limb alignment using 2D X-rays with AI-generated anatomical landmarks for precise angle and length measurements. spineEOS facilitates preoperative planning for spine surgeries with access to 3D spine datasets and clinical measurements, enabling tailored surgical strategies. Both tools support clinicians by improving diagnostic accuracy and surgical planning through advanced image analysis and AI.

The O-arm O2 Imaging System by Medtronic Navigation, Inc is a mobile X-ray device designed to provide detailed 2D and 3D imaging of patients' bony anatomy and metallic objects, mainly used during image-guided surgeries. It includes advanced software features such as metal artifact reduction and dose reduction using machine learning, helping clinicians obtain clearer images with lower radiation exposure for improved surgical navigation and patient safety.

SMART Bun-Yo-Matic CT is an AI-based software tool that helps orthopedic healthcare professionals by automatically segmenting foot and ankle bones from CT images, creating 3D anatomical models, measuring structures, and providing surgical planning visualizations. This supports diagnosis and treatment planning, especially for conditions like hallux valgus, through detailed, interactive reports and templates.

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.