FDA Radiology AI Devices

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 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.

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.

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.

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.

PeekMed web is a cloud-based software system designed to assist healthcare professionals in orthopedic pre-operative planning. It works with imported imaging studies to create 2D or 3D surgical plans, supporting multiple anatomical regions including hip, knee, upper limb, and foot. It features AI-powered automatic bone segmentation and landmarking to enhance planning accuracy and efficiency, providing a comprehensive surgical overview and reports to clinicians.

The MC2 Portable X-ray System by Oxos Medical is a handheld, portable X-ray device intended to help clinicians perform point-of-care imaging of joint and bone areas (extremities) outside of surgery. It uses advanced technologies including infrared tracking and LIDAR to position and ensure safe operation, producing high-quality images in single radiography, serial radiography, and fluoroscopic modes. The device connects wirelessly to tablets or monitors for image review and facilitates efficient orthopedic imaging in various clinical settings.

SyMRI is a software tool that processes MRI data to generate detailed maps of brain tissue properties and volumetric measurements. It enables visualization of multiple image contrasts from a single MRI scan and allows clinicians to adjust image contrasts after acquisition. This helps in better diagnosis and understanding of brain health by providing comprehensive and quantifiable tissue information.

The Magnetic Localization Patch Kit by Medtronic is an accessory device used with the Affera Integrated Mapping System to accurately track and navigate catheters during cardiac electrophysiology procedures. It uses electromagnetic-based tracking technology to provide real-time catheter localization and cardiac mapping, helping clinicians perform heart rhythm diagnoses and treatments more precisely.