FDA Radiology AI Devices

MySpine WebPlanner is a web-based surgical preoperative planning software that assists orthopedic and neurosurgeons by allowing them to view, store, measure radiological images, and plan surgical placement of spinal fixation and fusion devices. It supports surgeons in preparing surgical plans by providing detailed imaging and implant positioning information, helping improve clinical decision-making before spinal surgery.

brAIn™ Shoulder Positioning is a cloud-based software tool that assists shoulder surgeons in planning total shoulder replacement surgeries. It automatically segments CT images of the shoulder using machine learning, allowing clinicians to visualize shoulder anatomy, position implants interactively in 3D, and receive detailed pre- and post-operative measurements and reports, facilitating more accurate and efficient surgical planning.

Radlink GPS Pro Imaging is an advanced image processing software that assists orthopedic surgeons in hip procedures by measuring the acetabulum’s position relative to bone structures seen in radiological images. The software overlays digital annotations on images and offers measurement tools to help surgeons plan and execute hip, knee, and trauma component positioning more precisely, improving procedural accuracy and outcomes.

ApolloHipX is a software system designed to aid surgeons during Total Hip Replacement by precisely measuring the position and alignment of hip replacement components using radiological images. It integrates pre-operative 3D patient data with intra-operative 2D X-ray images to provide near-real-time assistive measurements, helping ensure the implants are correctly positioned relative to the patient's bone structures.

Clarify DL is a software solution that uses deep learning integrated with iterative image reconstruction techniques to reduce noise and improve image quality in Nuclear Medicine bone SPECT images. It helps clinicians by enhancing image clarity which potentially improves diagnostic confidence and patient outcomes.

The aprevo® Digital Planning software is a semi-automated surgical planning tool used by trained medical personnel. It processes 3D spine models in conjunction with clinician inputs to produce 3D models of spinal corrections and anatomical measurements, which assist surgeons in pre-operative planning for spine surgeries.

PeekMed web is a cloud-based software system designed to assist healthcare professionals in orthopedic pre-operative planning. It works with imported imaging studies to create 2D or 3D surgical plans, supporting multiple anatomical regions including hip, knee, upper limb, and foot. It features AI-powered automatic bone segmentation and landmarking to enhance planning accuracy and efficiency, providing a comprehensive surgical overview and reports to clinicians.

Navbit Rapid Surgical Plan is a software tool designed to assist surgeons in planning primary total hip replacement surgeries. It analyzes X-ray images of a patient's hip and spine to provide recommendations on the placement of hip replacement components, aiming to reduce complications. The software helps surgeons by offering data-driven guidance based on patient-specific anatomy and mobility.

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.

The UNiD Spine Analyzer is a web-based software tool that helps surgeons and healthcare providers view and measure spine-related medical images, plan surgical procedures, and simulate surgical strategies. It incorporates machine learning predictive models to assist in preoperative planning and includes a database of implant templates to aid in selecting and placing surgical implants. The software enhances clinical decision-making by providing quantitative radiographic parameters and predictive outputs for spine surgery planning.