FDA Radiology AI Devices

LVivo IQS is a software application that processes ultrasound images of the heart to detect, measure, and calculate key medical parameters for patients with suspected cardiac disease. It provides real-time quality score feedback on image quality, helping clinicians ensure the accuracy and usefulness of cardiac ultrasound scans, particularly the left ventricle function from the 4 chamber apical view. This tool assists clinicians by improving the reliability of echocardiographic assessments.

Saige-Density is a medical software that uses AI deep learning techniques to analyze digital mammograms, producing breast density categories based on ACR BI-RADS guidelines. It helps radiologists assess breast tissue composition by providing adjunctive information, improving breast cancer risk assessment and screening interpretation.

AEYE-DS is an AI-powered retinal diagnostic software that helps healthcare providers automatically detect more than mild diabetic retinopathy in adults with diabetes using fundus images from a Topcon NW400 camera. It improves screening efficiency by analyzing images to identify disease presence, helping to guide timely patient care.

HeartFlow Analysis is a software medical device that uses AI to analyze coronary CT angiography images. It provides detailed anatomical and physiological information about the coronary arteries, helping clinicians assess the risk and severity of coronary artery disease, aiding in treatment planning and diagnosis.

SomnoMetry, developed by Neumetry Medical Inc, is an AI-powered software that helps clinicians analyze sleep studies by automatically scoring physiological signals from polysomnography tests. It aids in diagnosing sleep quality and respiratory sleep disorders such as obstructive apnea, facilitating more efficient and accurate sleep study evaluations under clinical supervision.

The ZEUS System (Zio Watch) is a prescription-based wearable device and software system that uses AI to analyze cardiac signals from an ECG and PPG sensor to detect and report atrial fibrillation. It provides clinicians with detailed reports to aid in diagnosing and managing atrial fibrillation in adult patients.

The Vivid iq is a high-performance compact diagnostic ultrasound system designed for cardiovascular and shared service imaging. It assists healthcare professionals in ultrasound imaging, measurement, display, and analysis of human body and fluid, across a wide range of clinical applications including fetal, cardiac, abdominal, musculoskeletal, and vascular imaging. It incorporates advanced ultrasound modes such as Doppler, color Doppler, harmonic imaging, and real-time 3D imaging, supporting various transducers and enabling flexible clinical use in hospital and office environments.

The Eko Murmur Analysis Software (EMAS) is a cloud-based AI-driven tool that analyzes heart sound and ECG data to detect and classify heart murmurs, distinguishing between innocent and structural murmurs. It supports clinicians by offering decision support in evaluating heart sounds, enhancing the diagnostic process for pediatric and adult patients without replacing clinical judgment.

IDx-DR v2.3 is an AI-based diagnostic software that automatically detects more than mild diabetic retinopathy from retinal images captured with a Topcon NW400 fundus camera. It helps healthcare providers identify patients who need referral to eye care professionals, improving timely diagnosis and management of diabetic retinopathy.

The Atrial Fibrillation History Feature is a software application designed to analyze pulse rate data from Apple Watch sensors to detect episodes of irregular heart rhythm indicative of atrial fibrillation (AFib). It provides users with estimates of the amount of time spent in AFib over past periods and visualizes this alongside lifestyle data to help users understand the impact of their behavior on their condition. It assists patients in monitoring AFib burden over time but is not meant to replace traditional diagnosis or treatment methods.