FDA Radiology AI Devices

BriefCase is an AI-based software by Aidoc Medical that helps radiologists and trained medical specialists detect and prioritize urgent cases from CT scans of various body regions including head, chest, abdomen, and cervical spine. It flags images with suspected critical findings like fractures, intracranial hemorrhage, pulmonary embolism, intra-abdominal free gas, and large vessel occlusion, presenting low-quality preview images and notifications to accelerate clinical workflow. The software works in parallel with standard of care and does not alter original medical images, serving as a triage and notification aid but not a diagnostic device.

HALO is a cloud-based artificial intelligence software that helps medical specialists by analyzing brain CT angiograms to detect signs of large vessel occlusion, a serious condition associated with stroke. It runs alongside the standard imaging workflow and sends alerts to specialists to expedite patient evaluation and care, improving stroke diagnosis and treatment speed.

BriefCase by Aidoc Medical, Ltd. is an AI-powered software that analyzes contrast-enhanced chest CT scans to detect incidental pulmonary embolism. The software notifies radiologists of suspected positive cases via a desktop application, helping prioritize urgent cases for faster review without replacing the standard diagnostic process. It supports workflow improvements by flagging cases early, potentially saving hours in time to examination.

AccipioIx is an AI-based software that processes non-contrast head CT scans to identify signs of acute intracranial hemorrhage. It helps clinicians prioritize urgent cases for faster review by analyzing images and flagging suspected hemorrhages, improving workflow efficiency in acute care settings.

Rapid LVO is a software tool that helps hospitals and radiologists quickly identify and prioritize suspected cases of Large Vessel Occlusion (LVO) in head CT angiography images. It analyzes images using a software algorithm and provides notifications with preview images to assist clinical workflow, without replacing standard diagnostic procedures.

CINA is an AI-based software that assists radiologists by analyzing head CT scans and CT angiographies to flag suspected cases of intracranial hemorrhage and large vessel occlusion. It provides timely notifications with preview images to help prioritize cases for quicker evaluation, improving workflow and patient care without altering original images or making direct diagnoses.

BriefCase by Aidoc Medical, Ltd. is an AI-powered software that assists radiologists by automatically analyzing abdominal CT scans to detect suspected Intra-abdominal Free Gas pathologies. It notifies clinicians of positive findings via a desktop application to help prioritize and triage patient workflow, speeding up clinical decision-making while operating alongside standard care without altering original medical images.

qER is an AI-powered software designed to analyze non-contrast head CT scans to detect critical conditions like intracranial hemorrhage, mass effect, midline shift, and cranial fractures. It assists clinicians by prioritizing urgent scans for review, helping to speed up diagnosis without altering the original image data.

NinesAI is a software tool that uses artificial intelligence to automatically analyze head CT images for signs of intracranial hemorrhage and mass effect. It helps prioritize critical cases by notifying radiologists of potential emergencies to assist in timely and effective patient care. The software works alongside standard workflows and does not replace full clinical evaluation or diagnosis.

CuraRad-ICH is an AI-powered software that helps radiologists quickly identify and prioritize head CT scans that may show acute intracranial hemorrhage (bleeding in the brain). By automatically analyzing CT images, it assists in faster diagnosis and treatment decisions to improve patient outcomes.