FDA Radiology AI Devices

NextAR Spine is an augmented reality surgical navigation platform designed to help surgeons precisely locate anatomical structures during spine surgery. It uses CT imaging and intraoperative scans to guide the placement of screws and other instruments in the thoracic and lumbosacral spine, improving surgical accuracy and patient outcomes.

The TMINI Miniature Robotic System is a robotic surgical tool designed to assist orthopedic surgeons in accurately placing knee implant components during total knee replacement surgery. It uses preoperative CT scans to generate 3D models for surgical planning and utilizes robotic guidance during surgery to ensure precise bone preparation and implant placement, improving surgical accuracy and patient outcomes.

The Paradigm System by Proprio, Inc. is a surgical navigation system that helps surgeons precisely position spinal instruments during posterior spine surgeries. It combines preoperative CT-based 3D models of the spine with real-time camera imaging of the surgical site to enable accurate instrument placement, improving surgical accuracy and patient outcomes.

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.

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.

The Mako Total Hip Application 5.0 is a surgical assistive system that uses CT image data to create a 3D model of a patient's hip anatomy, helping surgeons plan and perform total hip replacement surgeries with high precision. It incorporates a robotic arm and software to guide implant placement within software-defined boundaries, improving surgical accuracy and patient outcomes.

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.

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.