FDA Radiology AI Devices

The HJY VisualNext 3D Endoscopic Vision System is a medical device designed to provide surgeons with a 3D visual of internal surgical sites during neurological, spinal, and general surgeries. It uses dual CMOS sensors and integrated LED lighting to capture and display high-resolution 3D images on an external monitor, helping clinicians better visualize the surgical area for improved precision and outcomes.

The Swoop® Portable MR Imaging® System is a portable, ultra-low field MRI device that produces images of the internal structure of the head. It incorporates a deep learning-based image reconstruction algorithm to enhance image quality, helping healthcare providers diagnose patients at the point of care, especially where full diagnostic exams are not practical.

The Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set is a device used to remove blood clots in patients suffering from acute ischemic stroke caused by large vessel blockages in the brain. It is used with a compatible vacuum pump to restore blood flow within 8 hours of stroke onset, helping patients who are not eligible for or have failed drug therapy. This system comprises catheters and tubing designed for safe and effective clot removal in neurovascular procedures.

ANKYRAS is a medical software device designed to assist clinicians in visualizing cerebral blood vessels and simulating the placement and sizing of neurointerventional braided endovascular devices such as flow diverters. It helps physicians plan neurovascular interventions by allowing 3D modeling based on imaging data from 3D rotational angiography, offering features like segmentation, centerline generation, and device simulation to improve pre-surgical planning and patient outcomes.

The Neu Platform is a smartphone application and clinician dashboard system designed to remotely measure and quantify tremor severity in patients aged 45 or older with mild to moderate Parkinson's Disease. It collects motion data via smartphone accelerometers, allowing patients to perform motor assessments and report symptoms remotely, while clinicians can review this data in a secure web portal to monitor and manage the patient's condition more effectively.

The Atlas Stim Headbox by Neuralynx, Inc. is a medical device intended for cortical or intracranial stimulation during EEG examinations, such as stereo EEG (SEEG). It works as an accessory to the ATLAS Neurophysiology System, enabling controlled electrical stimulation of the brain using third-party electrodes and recording the brain's electrical responses. This device assists neurosurgeons and neurologists in mapping brain function, especially in complex cases requiring precise neural stimulation.

GBrain MRI is a software tool that automatically segments, quantifies, and reports the volume of signal hyperintensities in brain MR FLAIR images. It helps radiologists by providing quantitative measurements to support the evaluation of brain MRI scans, enhancing clinical assessment without replacing the physician's judgment.

OTOPLAN is software that helps otologists and neurotologists visualize, segment, and analyze medical images such as CT and MRI scans to assist in planning and assessing ear-related surgical procedures like cochlear implantation. It provides tools for 3D reconstruction, electrode visualization, and image fusion, enhancing surgical planning accuracy and patient outcomes.

syngo.CT LVO Detection is an AI-powered post-processing software that analyzes CT angiography images of the brain to help clinicians prioritize cases by detecting suspected large vessel occlusions in specific brain vessels. It aids in triage but is not used for standalone diagnosis or altering images, thereby assisting medical professionals in managing stroke patients more efficiently.

NEAT 001 is a software medical device that automatically analyzes EEG data obtained during sleep studies to detect different stages of sleep according to established sleep medicine guidelines. It helps clinicians by providing automated scoring and visualization of sleep stages, improving the efficiency and consistency of sleep evaluations in adult patients.