FDA Radiology AI Devices

HipCheck is a software tool used during hip arthroscopy surgeries that helps surgeons measure the alpha angle related to femoroacetabular impingement (FAI). It processes X-ray images taken during surgery and overlays virtual measurement tools on these images to support clinical decision-making. It also includes a patient-specific report feature for preoperative planning using three-dimensional analyses and visualizations of the hip.

The OFIX MIS App is a mobile software application designed to help healthcare professionals view, store, and measure images to plan orthopedic surgeries, specifically for spinal implant procedures. It uses images captured via a mobile phone camera to assist in selecting the correct rod length for pedicle screw spinal systems, aiding surgeons in making precise implant placement decisions.

DeepXray is an AI-powered software that helps medical professionals analyze knee X-rays by automatically measuring joint space width and assessing signs of osteoarthritis such as sclerosis, joint space narrowing, and osteophytes. It supports clinicians by providing detailed grading based on established radiographic criteria and offers an interactive report for review and editing before finalizing.

Spine Auto Views is a software tool that automatically processes CT images of the spine to create anatomically focused reformatted views and labels vertebrae and disc spaces, facilitating quick and consistent review for clinicians. It utilizes deep learning algorithms to generate multiple reformatted image planes without user interaction and exports the results automatically for radiologist reading.

Spine CAMP™ (1.1) is an automated software that analyzes X-ray images of the lumbar and cervical spine to generate measurements and visualizations of spinal alignment, stability, degeneration, and motion. It supports healthcare professionals in clinical decisions related to spinal health by producing detailed reports from radiographic data.

Axial3D Insight is a cloud-based service that processes medical imaging DICOM data to create detailed 3D digital files or physical 3D printed models. These models assist clinicians in treatment planning and diagnosis across orthopedic trauma, maxillofacial, and cardiovascular applications, improving surgical preparation and outcomes.

IB Lab LAMA is a software tool that automatically analyzes full leg X-rays to measure discrepancies in limb length and assess knee alignment. It uses AI deep learning technology to provide precise geometric measurements to assist healthcare professionals in evaluating leg deformities and alignment issues, thereby supporting diagnosis and treatment planning.

Formus Hip is a preoperative planning software designed to assist orthopedic surgeons by automatically generating 3D models of the hip from CT scans and overlaying digital representations of hip implants. It uses AI algorithms for image segmentation and statistical shape modeling, helping clinicians plan hip replacement surgeries more effectively by customizing implant fitting interactively and producing printable surgical plans.

RadioLens v1.0 by Synapsica is a medical image management and processing system that allows radiologists and medical practitioners to view, analyze, and report on DICOM-format radiology images. The software includes an AI module called SpindleX for automated analysis and measurement of spinal ligament injuries in digital stress X-rays of the cervical and lumbar spine. This helps clinicians by providing quantitative measurements and detailed reports, enhancing diagnostic accuracy and efficiency in spinal injury assessment.

Spectral Bone Marrow is an automated deep learning-based software designed for spectral CT images of the body and extremities. It segments bone regions and creates enhanced, color-coded images to help radiologists better visualize bone marrow. This assists in diagnosing traumatic and non-traumatic bone conditions more efficiently by providing improved image visualization and an automated clinical workflow.