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.

The Zoom 7X Catheter, along with the Zoom Aspiration Tubing and Zoom POD Aspiration Tubing, is a sterile, single-use medical device designed to remove blood clots from large intracranial vessels in patients experiencing an acute ischemic stroke. It helps restore blood flow by aspirating the clot when connected to an aspiration pump, aiding clinicians in rapidly treating stroke and improving patient outcomes.

The Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set is a device used to remove blood clots in patients suffering from acute ischemic stroke caused by large vessel blockages in the brain. It is used with a compatible vacuum pump to restore blood flow within 8 hours of stroke onset, helping patients who are not eligible for or have failed drug therapy. This system comprises catheters and tubing designed for safe and effective clot removal in neurovascular procedures.

The CIONIC Neural Sleeve NS-200 is a wearable device that helps adults with foot drop and muscle weakness by electrically stimulating specific leg muscles to assist ankle and knee movements. It includes sensors to measure muscle activity, providing real-time biofeedback to guide stimulation and rehabilitation. It aims to improve gait, facilitate muscle re-education, prevent atrophy, and increase blood flow.

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.