FDA Radiology AI Devices

Videa Dental AI is a medical imaging AI product designed to analyze radiology images related to dental applications. It helps clinicians by providing automated assessment of dental images, supporting decision-making and improving diagnostic efficiency.

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.

VELMENI for DENTISTS (V4D) is an AI-powered medical image analyzer designed to assist dental professionals by analyzing medical images. It helps clinicians by providing insights and analysis to improve diagnostic accuracy in dental care.

OsteoSight™ Hip (v1) is a radiology software designed to opportunistically evaluate low bone mineral density from medical images, helping clinicians identify patients at risk for osteoporosis and related fractures.

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.

MammoScreen BD is an AI-powered software designed to assist radiologists by automatically analyzing mammography images. It helps detect and assess breast density, improving the accuracy and consistency of breast cancer screening and diagnosis.

Marie is a computed tomography (CT) X-Ray system designed to capture detailed cross-sectional images of the body, aiding clinicians in diagnosing and monitoring various medical conditions through advanced imaging techniques.

GyriCalc (Version 1.0.0) is a radiological image processing system designed to assist clinicians by analyzing brain images. It helps in quantifying gyri patterns in the brain, which can aid in neurological assessments and diagnosis.

TINGSN FINDERS 2 is a color Doppler ultrasound system that helps clinicians visualize and assess blood flow and heart function using pulsed Doppler ultrasound technology. It assists in cardiovascular diagnosis by providing detailed images and flow information in real time.

HeartFlow Analysis is a software tool that uses advanced imaging and computational models to simulate coronary vascular physiology. It helps clinicians assess blood flow in the coronary arteries non-invasively, aiding in diagnosis and treatment planning for cardiac patients.