FDA Radiology AI Devices

OnQ Neuro is an automated software device designed to analyze neurological MRI images, specifically for brain tumors. It performs automatic segmentation and quantification of tumor volumes and diffusion-weighted imaging data, helping clinicians assess tumor progression and treatment response more efficiently by providing quantitative and graphical image data that can be integrated into clinical workflows.

The Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) System by Hyperfine, Inc. is a portable MRI device designed to provide bedside imaging of the brain. It uses advanced deep learning for image reconstruction to reduce noise and blurring, enabling clinicians to view internal head structures more clearly. This system facilitates quicker and more accessible brain imaging in various care settings, aiding in diagnosis without the need to transport patients to traditional MRI suites.

StrokeSENS LVO is software that uses AI to analyze CT angiograms of the head to identify suspected large vessel occlusions, which can cause strokes. It assists healthcare providers by flagging potential LVO cases and sending notifications to specialists in near real-time, helping prioritize urgent cases and improve workflow efficiency. The software does not alter the original images and is intended to be used alongside existing diagnostic workflows.

SwiftMR is a software medical device designed to automatically enhance brain MRI images by reducing noise and improving image sharpness. It processes MRI scans in DICOM format using advanced deep learning models, helping radiology professionals obtain clearer images for better diagnosis and clinical decision-making without interrupting their workflow.

VBrain-OAR is a software device from Vysioneer Inc. designed to assist trained radiotherapy personnel in brain tumor radiation therapy treatment planning by automatically generating contours of organs at risk in brain MRI images using AI deep learning. It also provides image registration functions to align multi-modality medical images. This device supports clinicians by providing initial contour outlines to improve the efficiency and consistency of radiation treatment planning, while still requiring final confirmation by qualified personnel.

EYE-SYNC is a portable eye-tracking device that helps medical professionals diagnose concussions by recording and analyzing eye movements. It includes a head-mounted eye tracker, a display, and a tablet app that together monitor eye motion patterns to detect impairments linked to mild traumatic brain injury in sports-related head injuries. This assists healthcare providers in making timely and accurate concussion assessments.

InferRead CT Stroke.AI is an AI-powered software that helps hospitals and radiologists prioritize head CT scans by flagging suspected intracranial hemorrhage cases. It analyzes CT images using a deep learning algorithm and highlights potential emergency cases on a worklist, assisting clinicians in faster triage. The software operates alongside standard radiology workflows without altering images or removing cases, improving efficiency in detecting brain hemorrhages.

qER-Quant is an AI-powered software that processes non-contrast head CT scans to automatically identify and quantify key brain structures such as intracranial hyperdensities, lateral ventricles, and midline shift. It helps clinicians by providing volumetric data and visual overlays to aid in diagnosis and monitoring brain conditions over time.

HALO is an AI-powered notification software that analyzes brain CT angiograms to detect signs of suspected intracranial Large Vessel Occlusion (LVO). It helps clinicians by promptly notifying appropriate medical specialists to facilitate quicker evaluation and treatment of stroke patients, improving emergency care and patient outcomes.

EnsoSleep is a software medical device designed to analyze previously recorded physiological signals from sleep studies to automatically score sleep stages, detect arousals, leg movements, and various types of sleep-disordered breathing events. It supports both adult and pediatric patients and can be used for in-lab or home sleep tests. EnsoSleep assists clinicians by providing automated detection and scoring of events, which are then verified and can be edited by qualified clinicians to aid in diagnosing sleep disorders.