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 Nicolet EDX is a diagnostic system by Natus Neurology Incorporated that helps healthcare providers measure electrical activity in nerves and muscles through tests like nerve conduction studies, electromyography, and evoked potentials. It assists clinicians in assessing nervous system function, locating neural structures during surgery, and supporting diagnosis of neuromuscular conditions by recording and analyzing electrophysiological signals.

Rapid Neuro3D is an AI-powered medical software that processes CT angiography scans to provide 3D and 2D visualizations of the brain's arterial blood vessels. It helps physicians confirm the presence or absence of identified lesions and assists in evaluation and treatment planning by simplifying image interpretation.

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.

The Ziehm Vision RFD 3D is a medical imaging device that provides high-quality 2D and 3D fluoroscopic X-ray images during surgical and diagnostic procedures. It helps clinicians visualize complex anatomical structures such as bones, joints, and soft tissues in real-time, improving outcomes in orthopedic, neurological, trauma, and other surgeries. The system supports computer-assisted surgery by providing detailed imaging and C-arm positioning data, facilitating safer and more accurate interventions.

TechCare Trauma by Milvue is an AI software that analyzes 2D X-ray images to help clinicians detect, localize, and characterize fractures and elbow joint effusions in a wide range of anatomical areas and patient populations including neonates, children, and adults. The software integrates into existing medical imaging workflows and supports clinicians by highlighting suspicious findings, improving diagnostic accuracy without replacing primary clinical decision-making.

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 Aurora system is a hybrid medical imaging device combining nuclear medicine (SPECT) and computed tomography (CT) technologies to help healthcare professionals detect, diagnose, and monitor diseases such as cardiovascular disorders, neurological conditions, and cancer. It enhances images using advanced acquisition, gating, and software features, improving evaluation and patient care across a variety of clinical applications.

The Digital Color Doppler Ultrasound System (P60 Series) by Sonoscape Medical Corp. is an advanced ultrasound imaging instrument that uses multiple modes including color Doppler and AI-based features to help clinicians evaluate a wide range of body regions and conditions with high detail and accuracy. It supports AI-powered automatic recognition and measurement to aid in fetal ultrasound examinations and other diagnostic exams, improving workflow efficiency and diagnostic performance.

The EVIS EUS Endoscopic Ultrasound Center Olympus EU-ME3 is a real-time endoscopic ultrasound imaging system designed to be used with Olympus ultrasound endoscopes and probes. It captures ultrasound images within various internal organs such as the gastrointestinal tract, biliary and pancreatic ducts, and others. The system supports various ultrasound modes including B mode, Doppler modes, harmonic imaging, elastography, and shear wave quantification to provide comprehensive diagnostic information, helping clinicians in diagnosis and treatment planning.