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.

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 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.

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.

Sim&Size is a medical imaging software designed to help clinicians visualize cerebral blood vessels and simulate the placement and sizing of neurovascular implantable devices for preoperative planning. It uses 3D images from rotational angiography to provide 3D reconstructions, automatic vessel segmentation, and tools for sizing and positioning implantable devices, supporting better planning of neurovascular interventions and surgeries.

The Infrascanner Model 2500 is a noninvasive medical device designed to help detect traumatic brain hematomas in patients with head injuries. It uses near-infrared light to measure differences in hemoglobin concentration in the brain, which indicate the presence of hematomas. The device aids clinicians in quickly assessing patients for further CT scans, improving early diagnosis and treatment in hospital settings.

The HomeSleepTest (HST, HST REM+) by Somnomedics GMBH is a non-invasive, prescription device designed for home use to aid in the diagnosis of sleep disorders, including sleep-related breathing disorders. It records multiple physiological signals such as brain electrical activity (EEG), eye movements (EOG), muscle activity (EMG), oxygen saturation, heart rate, and snoring. The data is collected via frontal and mastoid electrodes and other sensors, then uploaded to a cloud platform for analysis by clinicians using specialized software. This helps physicians assess sleep quality and breathing disorders outside of hospital settings, improving patient comfort and accessibility to diagnostic testing.

NeuroMatch is a cloud-based medical software developed by LVIS Corporation to assist neurologists in reviewing and analyzing EEG recordings by automatically detecting potential seizures and epileptiform spikes. It employs advanced AI algorithms to highlight important EEG events, helping clinicians interpret brain activity more efficiently without providing a direct diagnosis.