FDA Radiology AI Devices

Methinks CTA Stroke is an AI software tool designed to assist clinicians by automatically analyzing CT angiography images of the brain to detect signs of stroke. It helps prioritize urgent cases by providing triage and notification, enabling faster diagnosis and treatment for patients.

Rapid CTA 360 by iSchemaView is an AI software designed to assist radiologists by automatically triaging and notifying critical findings on CT angiography scans. This helps clinicians quickly identify urgent conditions and prioritize patient care effectively.

The eMotus Respiratory Motion Management System by EmpNia Inc. helps monitor and record patients' breathing patterns to improve the accuracy of CT diagnostic imaging and radiation therapy. By tracking respiratory motion, it aids clinicians in synchronizing image acquisition and radiation delivery, reducing motion-related artifacts and improving treatment precision. The device uses optical fiber sensors attached to the patient's chest or abdomen to generate a respiratory waveform and gate signals that help coordinate imaging and therapy devices.

uOmniscan is a software that enables real-time remote collaboration and control of medical imaging devices, especially MRI scanners. It helps healthcare professionals remotely manage scans, train technicians, and enhance communication across different locations, increasing workflow efficiency and access to expert guidance.

Methinks NCCT Stroke is an AI-based software designed to assist clinicians by automatically analyzing non-contrast head CT scans to detect signs of intracranial hemorrhage and large vessel occlusion. It prioritizes and notifies suspected positive cases to improve workflow efficiency and triage in stroke care, offering rapid alerts that support clinical decision-making without replacing standard diagnostic procedures.

BriefCase-Triage by Aidoc Medical, Ltd. is an AI-powered software designed to assist radiologists by analyzing CT chest and abdomen scans and flagging cases with suspected aortic dissection. It helps medical specialists prioritize urgent cases by sending notifications and preview images, improving workflow efficiency without altering the original medical images or replacing diagnostic interpretation.

Annalise Enterprise is an artificial intelligence software designed to analyze chest X-ray images to detect several critical findings such as pneumothorax, tension pneumothorax, pleural effusion, pneumoperitoneum, and vertebral compression fractures. It supports clinicians by prioritizing studies containing these suspected findings to streamline and accelerate patient care workflow, aiding in triage and worklist management.

Rayvolve PTX-PE is an AI-based software tool designed to automatically analyze chest X-ray images for critical findings like pleural effusion and pneumothorax. It helps healthcare professionals prioritize cases by providing study-level notifications for worklist management, thereby improving the efficiency of radiological workflows without replacing clinical decision-making.

JLK-SDH is an AI-powered software that analyzes non-contrast CT head images to detect suspected subdural hemorrhage (SDH). It assists radiologists by notifying them of potential cases in a parallel workflow to standard care, enabling quicker communication and prioritization for specialist review. This helps clinicians promptly identify and manage patients with SDH, improving workflow efficiency and potentially patient outcomes. The device is intended for notification purposes only and does not replace diagnostic evaluation.

The EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) is software that assists medical professionals by automatically analyzing chest X-ray images to detect misplaced endotracheal tubes. It uses deep learning to flag suspicious cases and prioritize them in the workflow, helping radiologists review these urgent cases more quickly. The software provides alerts when the tube tip is positioned too high, too low, or incorrectly and supports clinical decision-making by improving triage efficiency.