FDA Radiology AI Devices

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.

CINA CHEST is an AI-powered software that analyzes chest and thoraco-abdominal CT angiography scans to detect signs of pulmonary embolism and aortic dissection. It helps radiologists prioritize cases by flagging suspected positive findings through notifications, thereby improving workflow efficiency and timely patient care. The tool works alongside standard image interpretation without altering original images and is not intended for diagnosis alone but as an aid for faster triage.

Viz ICH is an AI-powered software tool that analyzes non-contrast CT brain images to detect suspected intracranial hemorrhages. It sends notifications to neurovascular or neurosurgical specialists to facilitate earlier patient review and intervention. The software is integrated with a mobile application for previewing images and managing notifications, though image previewing is non-diagnostic and full diagnosis relies on standard clinical evaluation.

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.