FDA Radiology AI Devices

The ClearPoint System (Software Version 3.0) is a software platform that assists neurosurgeons by providing precise stereotactic guidance during neurological procedures such as biopsies and deep brain stimulation lead placements. It integrates with MR and CT imaging to automatically identify and segment brain structures and hardware components, improving procedure planning and monitoring. This system enhances the clinician's ability to accurately navigate and operate within the brain, supporting safer and more effective interventions.

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 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.

Brainomix 360 e-CTA is a software system used by trained medical professionals to analyze CT Angiography images of the brain. It processes these images to provide visualizations and quantitative measurements, such as vessel density asymmetry, specifically in the middle cerebral artery region. This helps clinicians assess cerebral blood vessel conditions and supports clinical decision-making for stroke and related conditions. The software uses AI/ML algorithms to improve vessel detection and image quality, and integrates with standard hospital imaging systems for ease of use.

JLK-ICH is an AI-powered software that analyzes non-contrast CT scans of the head to detect suspected intracranial hemorrhage. It provides automated notifications to clinicians to prioritize review, allowing faster communication and potentially improving patient outcomes. The software works alongside standard care without replacing diagnostic evaluations.

The Rist Radial Access Catheter family consists of single lumen catheters designed to provide access to peripheral, coronary, and neuro vasculature. These catheters assist clinicians in delivering interventional devices and diagnostic agents, particularly in neurovascular procedures, improving access with features like hydrophilic coatings and radiopaque markers for better visualization under fluoroscopy.

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 NIDO Baby Magnetic Resonance Imaging System is a specialized MRI device designed for imaging the brains of newborns and infants. It provides high-quality axial, sagittal, coronal, and oblique images of the internal structure of neonatal or infant heads, aiding doctors in diagnosis without using ionizing radiation. This system features a 0.35 Tesla permanent magnet with an open design optimized for safe and comfortable neonatal imaging.

Noxturnal Web is a web-based software designed to display, analyze, and manually score pre-recorded physiological data collected during sleep studies. It assists clinicians in diagnosing sleep and respiratory-related disorders by enabling detailed review and reporting of sleep stages and breathing events such as obstructive apneas, all under clinical supervision.