FDA Radiology AI Devices

The uWS-Angio Pro is an image processing system developed by Shanghai United Imaging Healthcare Co., Ltd. It is used in radiology to assist clinicians by processing medical images, potentially improving the visualization and analysis of angiographic studies.

Rapid Aortic Measurements is an AI-powered software product designed to automatically process radiological images to assist clinicians in measuring aortic structures quickly and accurately.

The Hypertension Notification Feature (HTNF) is a software-only mobile medical application by Apple that uses AI to analyze pulse sensor data collected by Apple Watch to notify users of possible hypertension. It helps adults over 22 years who are not diagnosed with hypertension to identify potential high blood pressure patterns, guiding them for further evaluation, but it is not a diagnostic or monitoring tool. It is designed for over-the-counter use, providing accessible cardiovascular health insights from wearable technology.

PRAEVAorta®2 by Nurea is an automated software tool designed to assist clinicians by processing radiological images of the aorta. It helps in analyzing medical images to provide more accurate and efficient assessments, supporting diagnosis and treatment planning related to aortic conditions.

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 FloPatch FP120 is a non-invasive cardiovascular blood flowmeter intended for use by medical professionals in hospitals and clinical settings. It utilizes continuous wave Doppler ultrasound to assess blood flow in peripheral vasculature. The device wirelessly transmits Doppler signals to a mobile application that displays blood flow measurements such as Max Velocity, Velocity Time Integral (VTI), and Corrected Flow Time, helping clinicians noninvasively monitor vascular health.

Mosaic V1.0.1 is a medical image analysis software that processes CT angiography images to help trained clinicians analyze arterial diseases such as atherosclerosis and aneurysmal disease. It offers 3D vessel visualization, measurements of vessel diameter, stenosis, and tissue volumes, supporting clinical decision-making though it does not provide direct diagnoses.

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.

uWS-Angio Basic is medical image management and processing software designed to handle X-ray angiographic, CT, and MRI images. It provides clinicians with tools for viewing, processing, calibration, and measurement of 2D and 3D vascular images, supporting improved diagnosis and treatment planning in angiography and related procedures.

The NES Reprocessed Visions PV .018 Digital IVUS Catheter is a medical device designed to image the inside of coronary and peripheral blood vessels using ultrasound. It provides real-time cross-sectional images to help clinicians evaluate vessel morphology as an adjunct to angiography, aiding in diagnosis and treatment planning for cardiovascular conditions.