FDA Radiology AI Devices

The Cerebral Autoregulation Index (CAI) Algorithm is a software tool designed to help clinicians monitor whether cerebral autoregulation—the brain's ability to maintain stable blood flow—is intact or impaired. It analyzes signals from cerebral oximetry and blood pressure monitors to provide an index value indicating the level of coherence between these parameters. This helps guide advanced hemodynamic monitoring in critical care patients without making direct therapeutic decisions.

The CEREGLIDE 42 and 57 Intermediate Catheters, together with the Cerenovus Aspiration Tubing Set, are medical devices used to remove blood clots from large intracranial vessels during acute ischemic strokes. These catheters are navigated through the brain's blood vessels under fluoroscopic imaging to restore blood flow by aspirating clots, helping patients who cannot receive or have failed drug-based clot dissolving treatments.

The xvision Spine System by Augmedics Ltd. is an augmented reality-based surgical navigation system designed to aid surgeons in precisely locating anatomical structures during open or percutaneous spine procedures. It combines preoperative CT or intraoperative X-ray imaging with a headset that overlays virtual 3D navigation information directly onto the patient's anatomy in real-time, enhancing surgical accuracy and safety for spine operations such as pedicle screw placement and other spinal trajectories.

VINT is a software tool designed to assist clinicians in viewing, processing, and quantitatively evaluating cerebrovascular MRI images. It imports DICOM-formatted MR images and analyzes blood flow characteristics of cerebral arteries, including providing signal intensity gradient metrics from TOF-MRA scans. It supports advanced image corrections and data visualization, aiding radiologists in assessing cerebral artery health without the need for contrast medium.

The Zeta Cranial Navigation System is a stereotaxic image guidance system designed to help neurosurgeons spatially position and orient surgical instruments during cranial surgery. It uses 3D preoperative CT or MRI scans to assist in real-time navigation without requiring rigid fixation of the patient. This system enhances the precision of neurosurgical procedures by providing visual guidance based on medical imaging data.

JBS-LVO is an AI-powered radiological software tool designed to analyze CT angiograms of the brain to detect suspected large vessel occlusions (LVOs). It notifies neurovascular specialists quickly via mobile app notifications to aid in rapid patient triage, supporting timely treatment decisions. The software provides compressed preview images for informational purposes, while diagnosis is made by specialists reviewing full-resolution scans.

Sourcerer is a software tool designed for neurologists and EEG technologists to visualize brain activity by integrating EEG data with MRI images. It helps localize sources of brain activity by projecting EEG signals onto an idealized head model, aiding in clinical diagnoses such as epilepsy evaluation.

Encevis (2.1) is a software tool that assists neurologists by automatically analyzing EEG recordings to detect seizures, spikes, electrographic status epilepticus, and other brain activity patterns. It reduces artifacts in EEG data, provides quantitative measures like frequency bands and burst suppression, and displays alerts to support rapid clinical decision-making, especially in acute care settings.

uAI Easy Triage ICH is an AI-powered software designed to assist radiologists by analyzing non-contrast head CT images to detect suspected intracranial hemorrhage (ICH). It helps prioritize and triage cases by flagging images that show possible bleeding in the brain, ensuring faster notification and workflow efficiency in hospital settings.

LumiNE US is a visualization software designed to help neurosurgeons and medical professionals prepare for surgery by converting 2D MRI and CT images into 3D models using AI-based segmentation. It enables visualization through augmented reality using head-mounted displays, assisting in understanding brain tumors and anatomy before surgery. The software is not intended for diagnostic use but to support surgical planning by providing enhanced image insights.