FDA Radiology AI Devices

The Optima Coil System is a medical device used in neurovascular procedures to embolize, or block, blood vessels in the brain. This helps treat conditions such as brain aneurysms or vascular malformations by preventing blood flow to problematic areas, supporting clinicians in preventing strokes or hemorrhages.

The EMBOTRAP III Revascularization Device is a specialized catheter used to remove blood clots from vessels in the brain, helping to restore blood flow in patients with ischemic stroke. It assists clinicians in performing minimally invasive procedures that can improve outcomes for stroke patients by clearing vessel blockages.

Brain WMH by Quantib BV is an automated software tool designed to analyze brain MRI images for white matter hyperintensities (WMH). It helps clinicians identify and quantify these lesions, improving diagnosis and monitoring of neurological conditions.

SwiftSight-Brain is a software designed to assist clinicians by automatically processing radiological images of the brain. It helps improve diagnostic efficiency by analyzing brain imaging data to support radiologists in identifying abnormalities.

Rapid Obstructive Hydrocephalus, or Rapid OH, is a computer-assisted software designed to analyze medical images of the brain to quickly identify cases of obstructive hydrocephalus, a condition involving fluid buildup in the brain. This software helps clinicians by providing rapid triage and notification, potentially improving patient outcomes by speeding up diagnosis and treatment.

Brainomix 360 Triage Stroke is a software designed to assist clinicians by automatically triaging and notifying them about stroke-related findings in brain imaging studies. This helps speed up diagnosis and ensures prompt patient treatment.

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.