FDA Radiology AI Devices

The Loop System by Spry Health, Inc. is a prescription-only wearable device designed for adult patients to collect physiological data such as oxygen saturation, heart rate, and respiration rate during resting periods. It passively records data using reflectance-based photoplethysmography from the wrist and uploads the information to a server for remote clinician review, aiding in patient monitoring in home environments.

KardiaAI is a software library by AliveCor that analyzes ambulatory ECG rhythms to identify heart conditions such as atrial fibrillation, bradycardia, and tachycardia. It supports integration into other ECG devices and helps clinicians by providing automated ECG noise filtering, heart rate measurement, and rhythm classification to inform diagnosis and monitoring.

RhythmAnalytics is a software tool that analyzes single-lead ECG data to detect cardiac arrhythmias and measure heart-related signals. It helps healthcare professionals by providing supportive interpretations and can be integrated with other devices or platforms to assist clinicians in diagnosing heart rhythm disorders.

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 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.

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.

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.

Centricity Universal Viewer by GE Healthcare is a medical imaging software solution designed to display, manage, analyze, and share medical images from multiple imaging modalities. It facilitates radiologists and cardiologists in interpreting diagnostic images, improving workflow and clinical decision-making. It supports many imaging formats but is not intended for digital pathology diagnosis. The product enhances clinicians' ability to view and interpret images efficiently across healthcare systems.

The AI-ECG Platform by Shenzhen Carewell Electronics is an AI-powered software that assists healthcare professionals in measuring and interpreting 12-lead resting electrocardiograms (ECGs). It automatically analyzes ECG data, provides diagnostic interpretations for common cardiac abnormalities, and enables physicians to review and modify results. This helps clinicians make more informed cardiac assessments in hospitals and healthcare facilities.

icobrain is an AI-powered software that automates the identification, labeling, and volume measurement of brain structures from MR and CT images. It assists clinicians in evaluating brain conditions such as dementia and traumatic brain injury by providing detailed volumetric reports and visual overlays, improving the efficiency and accuracy of brain image analysis.