FDA Radiology AI Devices

CINA-CSpine by Avicenna.AI is a radiological computer-assisted triage and notification software that uses AI algorithms to analyze cervical spine CT scans for suspected acute fractures. It helps hospital networks and trained physicians by flagging potential fracture cases and prioritizing image review, enabling faster and more efficient diagnosis and patient care. It operates alongside the standard care workflow without altering original images, providing notifications with preview images for informational purposes.

Viz LVO is an AI-based software tool designed for hospital networks and clinicians to detect and notify specialists about suspected large vessel occlusions in brain CT angiograms. It facilitates rapid communication and prioritization of cases to improve stroke patient management, providing image previews via a mobile app for informational use to assist timely specialist review.

BriefCase by Aidoc Medical is an AI-powered software that analyzes CTPA images to detect suspected Pulmonary Embolism cases and notifies clinicians via a desktop application to prioritize these potentially critical cases. It works alongside the standard image interpretation process, helping healthcare professionals triage faster and improve patient care without altering original medical images.

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.

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.

Viz ICH is an AI-based software tool designed to analyze non-contrast CT scans of the brain for signs of intracranial hemorrhage (ICH). When the software detects suspected ICH, it sends notifications to neurovascular or neurosurgical specialists, helping speed up patient care by alerting clinicians early. The system includes a backend server for image processing and a mobile app for reviewing images in a non-diagnostic way for quick assessment and communication.

BriefCase by Aidoc Medical, Ltd. is an AI-powered radiological software that helps radiologists quickly identify head CTA images with suspected Large Vessel Occlusion. It provides notifications and compressed preview images in parallel to standard image interpretation to speed triage and prioritization, enhancing clinical workflow without replacing full diagnostic review.

DeepCT is an AI software tool that analyzes non-contrast CT brain images in acute settings to detect signs of intracranial hemorrhage. It sends notifications to specialists to prioritize and review cases quickly, improving workflow and potentially speeding patient care. It supports, but does not replace, radiologists' diagnostic process.