FDA Radiology AI Devices

Alignment System Cranial by Brainlab AG is a surgical navigation system designed to assist surgeons during cranial stereotactic procedures such as biopsies of intracranial lesions and placement of stereo-electroencephalography electrodes. It integrates optical tracking with advanced software and hardware to precisely guide surgical instruments, improving accuracy and safety. The system includes artificial intelligence features that aid in patient registration processes by detecting anatomical landmarks, enhancing surgical planning and execution.

AIRAscore is an AI-powered software that automates the identification, labeling, and volumetric measurement of brain structures from MRI scans. It helps clinicians quickly obtain detailed brain volume information, which can aid in diagnosis and monitoring of neurological conditions by providing consistent and accurate brain segmentation results.

The Dreem 3S is a wearable headband device that uses EEG electrodes and a 3D accelerometer to record brain electrical activity and movement during sleep. It applies an artificial neural network to automatically analyze and classify sleep stages, providing clinicians with detailed reports of patients' sleep patterns to aid in sleep assessment at home or in healthcare settings.

Annalise Enterprise CTB Triage-OH is an AI-powered software tool designed to help clinicians prioritize brain CT scans by detecting features suggestive of obstructive hydrocephalus. It integrates with hospital imaging and order management systems to flag and prioritize suspicious cases, enabling faster review and improving clinical workflow without replacing clinical decision-making.

Brainomix 360 Triage ICH is a software tool that uses artificial intelligence to analyze non-contrast brain CT images in acute settings to detect suspected intracranial hemorrhages. It notifies specialists promptly to prioritize patient care and improve workflow efficiency by providing timely alerts via mobile and web applications. It supports clinicians by assisting triage but does not replace diagnostic evaluation.

The Rapid Aneurysm Triage and Notification device by iSchemaView Inc. is an AI-powered software designed to analyze CT angiography images of the head to detect suspected saccular aneurysms. It helps hospital networks and radiologists by prioritizing cases with potential aneurysms for faster review, improving workflow in routine patient care. The software provides notifications and compressed preview images for informational use, supporting radiologists in triage but not intended for diagnosis.

ANDI is a software tool that processes diffusion-weighted MRI brain scans to create 3D maps of white matter tracts. It helps neurologists and radiologists by providing detailed visualization and measurements of brain white matter structures, serving as an adjunct tool for patient assessment without making diagnoses.

OptimMRI is a software tool that helps medical professionals analyze pre-operative brain MRI images by generating 3D annotated models. It supports neurosurgical planning by localizing key brain regions, helping doctors visualize and plan treatments more precisely.

The Cranial Navigation and Cranial EM System by Brainlab AG is an image-guided surgical navigation system designed to assist surgeons during cranial and craniofacial procedures. It uses imaging data like CT, MR, X-Ray, and ultrasound to track surgical instruments relative to patient anatomy. The system integrates artificial intelligence via machine learning algorithms to detect brain abnormalities and anatomical landmarks in MR images to enhance registration accuracy and view centering, helping surgeons perform more precise navigation in complex brain surgeries.

Brainlab Elements is a suite of software applications that process and analyze medical image data from various modalities to assist clinicians in planning surgeries and radiation treatments. It offers tools for image registration (fusion), segmentation (contouring), diffusion tensor imaging (fibertracking), blood oxygen level dependent MRI analysis (BOLD MRI mapping), and cerebrovascular image fusion (Image Fusion Angio). These capabilities help improve precision and understanding of patient anatomy and function during clinical procedures.