FDA Radiology AI Devices

NeuroMatch is a cloud-based medical software developed by LVIS Corporation to assist neurologists in reviewing and analyzing EEG recordings by automatically detecting potential seizures and epileptiform spikes. It employs advanced AI algorithms to highlight important EEG events, helping clinicians interpret brain activity more efficiently without providing a direct diagnosis.

The Dreem 3S is a wearable headband device that records brain electrical activity (EEG) and movement data during sleep. It uses AI algorithms based on neural networks to automatically analyze this data and produce detailed sleep stage reports for adults. This helps clinicians assess sleep patterns and disturbances remotely in home or healthcare environments.

The Natus BrainWatch System is a portable EEG monitoring device that records and visually presents EEG signals to assist trained medical personnel in neurological diagnosis for patients aged 2 years and older. It features a disposable headband with integrated electrodes, wireless connectivity, and cloud storage, enabling rapid and convenient EEG monitoring in healthcare settings.

NeuroICH is a software tool designed to analyze non-contrast CT scans of the head using artificial intelligence to detect signs of intracranial hemorrhage. It provides notifications to specialist clinicians via a mobile app, helping to prioritize patient care without replacing standard diagnostic procedures.

icobrain aria is a software tool that helps radiologists detect and assess amyloid-related abnormalities in brain MRI scans of Alzheimer's disease patients undergoing antibody treatment. It uses AI to highlight and measure edema and microhemorrhages, aiding in clinical decisions and monitoring disease progression safely and effectively.

JLK-PWI is a software tool used by trained medical professionals to analyze special types of brain MRI scans called diffusion-weighted and perfusion-weighted images. It helps calculate parameters related to tissue water diffusion and blood flow, assisting clinicians in understanding brain tissue conditions. The software integrates with standard hospital imaging systems and allows for viewing and analysis, aiming to support diagnosis and treatment planning.

The Caduceus S is an augmented reality-based navigation system designed to assist surgeons in accurately placing pedicle screws during percutaneous spine surgery. It leverages intraoperative CT or 2D/3D C-arm imaging and optical tracking, projecting navigation data directly into a headset worn by the surgeon to improve precision and visualization during procedures involving the thoracic and lumbosacral spine.

The Riptide Aspiration System is a medical device designed to restore blood flow in patients suffering from acute ischemic stroke caused by intracranial large vessel occlusions. It uses continuous aspiration via specialized catheters and pumping system to remove blood clots from critical arteries in the brain, helping clinicians quickly reopen blocked vessels and potentially improve patient outcomes.

Neurophet AQUA (V3.1) is an automated medical software that analyzes brain MR images to help doctors by labeling, visualizing, and measuring brain structures and lesions. It compares these measurements to reference data, enabling clinicians to assess brain changes or abnormalities more efficiently and accurately.

nordicMEDiVA is an advanced software platform designed to analyze and visualize functional and dynamic MRI data of the brain. It automates image processing pipelines and provides clinicians with derived imaging parameters through a web-browser interface, facilitating the evaluation of brain function and structure to aid clinical decision-making.