FDA Radiology AI Devices

AutoContour (Model RADAC V4) by Radformation, Inc. is a software tool designed to automatically contour anatomical structures on CT and MR images to aid radiation treatment planning. Using machine learning, it helps clinicians create accurate contours of organs and tissues, streamlining the preparation process for radiation therapy and improving planning precision.

The Digital Radiography System (ManntiX B, ManntiX K) by Shenzhen Browiner Tech Co., Ltd is a portable digital X-ray system designed to acquire high-quality X-ray images of various parts of the patient's anatomy including head, spine, chest, abdomen, pelvis, and extremities. It supports different digital detectors and image processing systems to assist clinicians in obtaining and viewing diagnostic images conveniently. It helps physicians and technicians capture diagnostic X-ray images efficiently in diverse clinical settings.

The HemoSphere Alta Advanced Monitoring Platform is an advanced medical monitoring system used primarily in critical care for adult and pediatric patients. It combines data from various catheters and sensors to continuously measure cardiac output, pressures, blood oxygenation, and derived hemodynamic parameters. The system provides clinicians with insights about cardiac function and patient status through integrated algorithms and a user-friendly interface, supporting decision-making in complex clinical scenarios.

The PowerCube+ Series by GANSHORN Medizin Electronic GmbH is a medical device designed for professional healthcare settings to measure lung function in patients 5 years and older. It performs multiple pulmonary function tests such as Spirometry, Body Plethysmography, Lung Diffusion, Occlusive Resistance, and Respiratory Muscle Strength measurements. These tests help clinicians obtain detailed physiological parameters used to diagnose and monitor lung conditions. The device uses ultrasound technology for flow measurement, an air-tight chamber for body plethysmography, and gas analyzers to assess lung diffusion capacity. It supports electronic medical record integration, providing accurate and reliable data for respiratory assessment.

The Verily Numetric Retinal Camera is a non-contact, high resolution digital imaging device designed to photograph, display, and store images of the retina under non-mydriatic conditions. It aids clinicians in the evaluation, diagnosis, and documentation of ocular health by providing high quality retinal images.

The HomeSleepTest (HST, HST REM+) by Somnomedics GMBH is a non-invasive, prescription device designed for home use to aid in the diagnosis of sleep disorders, including sleep-related breathing disorders. It records multiple physiological signals such as brain electrical activity (EEG), eye movements (EOG), muscle activity (EMG), oxygen saturation, heart rate, and snoring. The data is collected via frontal and mastoid electrodes and other sensors, then uploaded to a cloud platform for analysis by clinicians using specialized software. This helps physicians assess sleep quality and breathing disorders outside of hospital settings, improving patient comfort and accessibility to diagnostic testing.

CDM Insights is a software tool that helps trained healthcare practitioners analyze brain MRI scans of adults over 45 years old. It automatically segments and quantifies brain structures and white matter hyperintensities, compares findings with normative data from healthy populations, and provides easy-to-understand visual and numerical reports. This aids clinicians in evaluating neurological conditions more accurately and efficiently.

Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert is a software tool designed to assist trained medical professionals by providing advanced image processing and analysis of MRI and CT scans, specifically for brain perfusion and diffusion imaging. It helps visualize hemodynamic properties and tissue characteristics important for managing conditions like acute stroke by automatically identifying regions of interest and calculating volumetric and perfusion parameters, improving diagnostic and treatment decision workflows for clinicians.

DrAid™ for Liver Segmentation is a web-based AI software that assists healthcare professionals in analyzing liver images from CT scans. It generates semi-automated liver segmentation and allows physicians to manually refine these segmentations and identify lesions, aiding in evaluation and treatment planning without providing direct diagnosis.

The EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) is an AI-powered software tool that analyzes non-contrast head CT images to identify signs of midline shift. It assists radiologists by flagging cases that may need urgent attention, helping prioritize patient care without altering original images or making direct diagnostic decisions.