FDA Radiology AI Devices

AI Rad Companion (Engine) by Siemens Medical Solutions is a software platform designed to assist technicians and physicians in viewing, processing, and analyzing medical images from multiple modalities. It supports integration with PACS systems and allows external AI-based post-processing extensions, improving clinical image analysis and workflow.

The SIGNA Premier is a whole body magnetic resonance imaging (MRI) scanner designed to produce high-resolution and high signal-to-noise ratio images in short scan times. It supports imaging of multiple body regions including the head, spine, breast, heart, abdomen, and musculoskeletal system, and uses advanced software featuring deep learning algorithms to automate steps in brain MRI examinations, thereby helping clinicians improve workflow and diagnostic consistency.

The Study Watch by Verily Life Sciences LLC is a wearable ECG monitoring device that records and securely transmits single-channel ECG waveforms. It assists healthcare professionals in tracking heart rhythms of adult patients with known or suspected heart conditions by enabling remote ECG data collection and review via a web portal.

MRCP+ v1.0 is a standalone software device from Perspectum Diagnostics that assists trained operators in the quantitative, non-invasive assessment of the biliary system using MR imaging data. It automatically generates 3D models of the biliary tree, measures bile duct widths, detects regions of variation, and provides tools for segmentation and volumetric analysis. This helps radiologists and clinicians better visualize and evaluate hepatobiliary structures, potentially improving diagnosis and patient care in biliary system diseases.

AmCAD-UO is a software application designed to analyze ultrasound images of the upper airway. It helps physicians visualize and quantify airway size, position, and tissue characteristics to monitor airway conditions more effectively. It supports manual and interactive region selection for detailed analysis and is intended to assist clinical evaluation, not to be used as a sole diagnostic tool.

EyeBOX is a device that uses an eye-tracking camera and software to measure and analyze eye movements as an aid in assessing concussion within one week of head injury for patients aged 5 to 67. It provides clinicians with a score indicating possible brain injury based on abnormal eye movement patterns, helping supplement traditional neurological assessment.

Quantib ND is an AI-powered software that processes MRI brain scans to automatically identify and measure volumes of various brain structures and white matter hyperintensities. It provides 3D visualizations and quantitative data to assist medical professionals in evaluating brain images and supporting quantitative reporting, making brain MR image assessment more precise and efficient.

iSchemaView RAPID is a software package that helps medical professionals view and analyze CT and MRI images, particularly to evaluate stroke patients for endovascular thrombectomy. It provides advanced image processing for perfusion, diffusion, and angiography to aid clinical decision-making.

vascuCAP is a medical image analysis software designed to help clinicians process and evaluate multidimensional CT images of arterial vessels. It provides tools to visualize vessels in 3D and measure key anatomical features such as lumen boundaries, vessel stenosis, and plaque characteristics. This assists physicians in stratifying patients with atherosclerosis by providing detailed vessel information to complement standard care.

Embrace is a wearable device worn on the wrist that monitors physiological signals such as Electrodermal Activity, motion, and temperature to detect generalized tonic clonic seizures in patients with epilepsy. It helps alert caregivers by sending notifications during seizure events, assisting in timely monitoring and care for patients both at home and in healthcare facilities.