FDA Radiology AI Devices

GBrain MRI by Galileo CDS, Inc is an AI-powered software designed to process MRI images automatically, helping radiologists interpret brain scans more efficiently.

Methinks CTA Stroke is an AI software tool designed to assist clinicians by automatically analyzing CT angiography images of the brain to detect signs of stroke. It helps prioritize urgent cases by providing triage and notification, enabling faster diagnosis and treatment for patients.

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.

Neuro Insight V1.0 by Olea Medical S.A.S. is an advanced image processing system designed for radiological applications. It helps clinicians by processing medical images, potentially enhancing the insight gained from them for neurological assessments.

GyriCalc (Version 1.0.0) is a radiological image processing system designed to assist clinicians by analyzing brain images. It helps in quantifying gyri patterns in the brain, which can aid in neurological assessments and diagnosis.

The Affirm 800 is a surgical imaging device that helps neurosurgeons visualize blood flow and vessel patency in the brain during operations. It works by using near-infrared light to activate a fluorescent dye (Indocyanine Green) injected into the bloodstream, allowing surgeons to see detailed images of cerebral vessels on a 3D monitor in real time. This aids in assessing occlusions and blood flow in vessels, improving surgical outcomes.

The Neuralytix iD3 System is a surgical nerve stimulator and locator that helps surgeons find and monitor motor nerves during surgery by measuring muscle responses to electrical stimulation. It uses mechanomyographic signals to assess nerve function in real-time, enabling safer and more effective surgical interventions involving nerve mapping and monitoring.

RT Elements 4.5 is a computer-based software suite designed to assist clinicians in planning radiation treatments for brain, spine, and extracranial lesions. It supports stereotactic and conformal radiation therapy by providing optimized treatment plans, dose reviews, and AI-based tumor segmentation, helping improve accuracy and efficiency in patient treatment.

Methinks NCCT Stroke is an AI-based software designed to assist clinicians by automatically analyzing non-contrast head CT scans to detect signs of intracranial hemorrhage and large vessel occlusion. It prioritizes and notifies suspected positive cases to improve workflow efficiency and triage in stroke care, offering rapid alerts that support clinical decision-making without replacing standard diagnostic procedures.

Brainlab Elements (7.0) is a suite of medical imaging software applications that aid clinicians in planning cranial and extracranial surgical and radiotherapy treatments. It provides tools for image fusion (aligning different imaging datasets), angiographic image registration, contouring (outlining anatomical structures), fibertracking (visualizing brain white matter tracts from diffusion imaging), and functional MRI mapping. The device supports precise treatment planning by combining and analyzing various imaging data, helping clinicians visualize critical anatomical and functional areas without being used for diagnostic purposes.