FDA Radiology AI Devices

The Europa (AiRTouch) portable X-ray system is a mobile diagnostic device designed for imaging extremities in both adult and pediatric patients aged 12 and older. It produces high-quality X-ray images using adjustable tube current and voltage and supports image capture through film or digital receptors. This system is portable, battery-operated, and intended for use by trained clinicians, facilitating easier and flexible diagnostic imaging outside traditional radiology suites.

Accuro 3S is a portable diagnostic ultrasound imaging system designed for use by trained healthcare professionals in hospitals or clinics. It provides B-mode ultrasound imaging with an advanced AI-based software called SpineNav-AI that assists with musculoskeletal imaging of the lumbar spine, especially guiding neuraxial anesthesia procedures. This system enhances clinicians' ability to accurately visualize anatomical structures and guide needle placements safely and efficiently.

Mixed Reality Spine Navigation is an accessory software used with Brainlab's Spine & Trauma Navigation platform. It employs a mixed reality headset (Magic Leap 2 Medtech) to provide surgeons with 2D and 3D floating visualizations of the patient's spine anatomy and tracked surgical instruments during pedicle screw placement surgery, enhancing intraoperative navigation and precision.

The MasteRad MiniX Mobile Digital Imaging System (Mini-X) is a portable fluoroscopic X-ray system designed for real-time imaging and guidance during diagnostic radiography and surgical procedures of the extremities. Its mobility and advanced imaging technology facilitate easy positioning and high-quality visualization to assist medical professionals in various clinical settings, except neonates and mammography.

OTS Hip is an orthopedic surgical system designed to aid surgeons in preoperative planning and intraoperative navigation of hip replacement surgeries. It uses CT and X-ray medical imaging data and combines software and hardware components to create a 3D model of the patient's unique anatomy, guiding surgical instrument and prosthetic placement in real-time. This helps improve the accuracy and safety of total hip arthroplasty procedures.

The Altus Spine Navigation System is a set of reusable surgical instruments designed to assist surgeons in accurately placing pedicle screws during spinal surgery. It works together with a navigation system that uses medical images like CT or MRI scans to help locate anatomical landmarks, improving precision in both open and minimally invasive procedures. This system helps enhance surgical accuracy and patient safety by guiding screw placement in the spine.

Clarius Median Nerve AI is a machine learning-based software integrated with the Clarius Ultrasound Scanner system. It automatically segments the median nerve and measures its cross-sectional area in ultrasound images of the wrist and forearm. This tool assists trained healthcare professionals by providing semi-automated measurements to support clinical assessment in musculoskeletal ultrasound imaging, improving efficiency and accuracy while allowing manual adjustments.

The CIONIC Neural Sleeve NS-200 is a wearable device that helps adults with foot drop and muscle weakness by electrically stimulating specific leg muscles to assist ankle and knee movements. It includes sensors to measure muscle activity, providing real-time biofeedback to guide stimulation and rehabilitation. It aims to improve gait, facilitate muscle re-education, prevent atrophy, and increase blood flow.

The Dynamis Robotic Surgical System is a robotic platform designed to assist surgeons in precisely locating anatomical structures and guiding surgical instruments during spine surgeries. It uses real-time tracking and intraoperative CT images to navigate and position surgical tools accurately, especially for placing spinal pedicle screws in the thoracic, lumbar, and sacral regions. This helps improve surgical accuracy and patient safety.

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.