FDA Radiology AI Devices

The MONARCH™ Platform is a robotic bronchoscopy system that provides physicians with precise, image-guided navigation and visualization of patient airways. It integrates electromagnetic tracking with real-time video from a flexible bronchoscope and can optionally update navigation using live imaging from Cone Beam CT scans. This aids clinicians in diagnosing and treating lung conditions with improved accuracy and control.

The Geniant Cranial is a navigated neurosurgical positioning robot designed to assist neurosurgeons in accurately locating anatomical structures and guiding surgical instruments during neurosurgical procedures. It uses preoperative CT or MR images to create 3D models and tracks surgical tools in real-time, helping surgeons plan and follow surgical routes more precisely, thereby improving surgical outcomes and safety.

The Affera Integrated Mapping System is a software and hardware system designed to help cardiologists map the heart's electrical activity during catheter-based procedures. It uses magnetic and electromagnetic tracking to visualize catheters inside the heart in real time, records electrical signals from the heart, and displays 3D cardiac maps. This assists clinicians in diagnosing and treating heart rhythm disorders with improved accuracy and guidance.

The NuVasive Pulse System is a medical device that helps surgeons precisely locate anatomical structures during spinal surgeries using intraoperative 3D imaging and computer-assisted navigation. It tracks surgical instruments in real-time and overlays their virtual positions on patient images, enhancing surgical accuracy and safety in procedures like pedicle screw placement and iliosacral screw placement.

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.

The FLASH EVD System is a stereotactic image-guided navigation tool designed to assist surgeons in the precise placement of external ventricular drain catheters during neurosurgery. It uses preoperative imaging and real-time tracking to improve accuracy and workflow during procedures that relieve intracranial pressure. This helps surgeons position instruments more accurately without rigidly fixing the patient or instruments.

The Remex Spine Surgery Navigation Instrument is designed to assist surgeons in precisely positioning surgical tools and spinal implants during spinal surgeries. It works by integrating fluoroscopic and CT images to guide procedures like pedicle screw placement, enhancing surgical accuracy and patient safety.

The Magnetic Localization Patch Kit by Medtronic is an accessory device used with the Affera Integrated Mapping System to accurately track and navigate catheters during cardiac electrophysiology procedures. It uses electromagnetic-based tracking technology to provide real-time catheter localization and cardiac mapping, helping clinicians perform heart rhythm diagnoses and treatments more precisely.

CORIOGRAPH Pre-Op Planning and Modeling Services is a software tool used for preoperative planning of orthopedic surgeries such as unicondylar knee replacement, total knee arthroplasty, and primary total hip arthroplasty. It generates patient-specific bone models and surgical plans based on medical imaging scans, helping surgeons plan and optimize implant placement before surgery.

The Mako Shoulder Application (1.0) is part of the Mako System designed to assist surgeons in reverse shoulder arthroplasty procedures by providing AI-driven, software-defined spatial boundaries using patient CT imaging. It aids in pre-surgical planning, implant placement, and intraoperative navigation, improving surgical accuracy and outcomes.