FDA Radiology AI Devices

The Primus Spinal Fixation System is a spinal fixation device designed to provide stabilization and immobilization for the thoracic, lumbar, and sacral spine regions. It includes screws, rods, and connectors that can be precisely placed with the aid of navigation instruments compatible with the Medtronic StealthStation System, which uses medical imaging data like CT and MRI scans to assist surgeons in accurate screw placement during spinal surgeries.

ScanDiags Ortho L-Spine MR-Q is an AI-powered software tool that processes previously acquired lumbar spine MRI images to provide quantitative measurements of spinal anatomical structures such as vertebral bodies, intervertebral discs, neuroforamina, and thecal sacs. It utilizes deep learning algorithms for semi-automatic segmentation and measurements, allowing radiologists to review and adjust results. This tool helps clinicians save time and improve the accuracy of lumbar spine assessment without replacing their expert interpretation.

The Paradigm System is a surgical navigation device that helps surgeons accurately place spinal surgical instruments during open procedures. It integrates real-time high-resolution camera images of the surgical site with preoperative CT imagery to create a 3D model of the spine, enabling precise instrument placement and improving surgical accuracy and safety from thoracic to sacrum vertebrae.

BoneMetrics (US) is an AI-powered software that automatically measures Cobb angles on frontal spine x-rays to assist healthcare professionals in evaluating spinal deformities such as scoliosis. It integrates with existing imaging systems to provide quantitative angle measurements that can support clinical decision-making, improving workflow efficiency and consistency.

MyShoulder Planner is a software tool designed for surgeons to plan total shoulder replacement surgeries. It processes CT scans to create 3D models of the patient's shoulder anatomy using machine learning algorithms, helping surgeons decide implant size and positioning before surgery. It also generates patient-specific reports and allows ordering of patient-matched guides to assist in surgery.

The Precision AI Surgical Planning System (PAI-SPS) is an AI-enhanced medical device that assists surgeons in planning and performing shoulder joint replacements. It uses CT scan images to create a 3D model of the patient's shoulder, helps surgeons simulate and optimize implant positioning, and can produce custom surgical guides for use during the procedure. This system helps improve surgical accuracy and outcomes for shoulder arthroplasty patients.

TechCare Trauma by Milvue is an AI software that analyzes 2D X-ray images to help clinicians detect, localize, and characterize fractures and elbow joint effusions in a wide range of anatomical areas and patient populations including neonates, children, and adults. The software integrates into existing medical imaging workflows and supports clinicians by highlighting suspicious findings, improving diagnostic accuracy without replacing primary clinical decision-making.

TBS iNsight (V4) is a software tool that processes bone density images from DXA scans to calculate a Trabecular Bone Score (TBS). This score helps clinicians assess bone quality and fracture risk, complementing standard bone density measurements. The software improves the accuracy of evaluating osteoporosis and bone health, aiding in diagnosis and treatment monitoring.

The Orthoscan VERSA Mini C-Arm is a mobile fluoroscopic X-ray system designed to provide real-time imaging for diagnostic, surgical, and emergency procedures, particularly focused on limbs, extremities, and shoulders. The system enhances clinical workflow by delivering high-quality fluoroscopic images with improved ergonomics and efficiency, helping clinicians to visualize anatomy during treatment.

The ARVIS® Shoulder is an AI-powered computer navigation system designed for shoulder replacement surgery. It helps surgeons accurately position implants by using preoperative CT imaging and provides augmented reality visual guidance during the procedure, enhancing surgical precision and patient outcomes.