FDA Radiology AI Devices

KIDScore D3 is an AI-based decision support tool designed to aid embryologists in assessing the viability of embryos on Day 3 by scoring their likelihood to develop to the blastocyst stage. It integrates with the EmbryoScope timelapse incubator systems and helps clinicians select embryos for transfer, freezing, or continued development, enhancing decision-making in assisted reproduction procedures.

The physIQ Heart Rhythm and Respiration Module is a software device that analyzes ECG signals and movement data to calculate heart rate, heart rate variability, detect atrial fibrillation, and determine respiration rate. It helps clinicians remotely monitor cardiac and respiratory health in adult patients outside of critical care settings, enhancing patient care through advanced signal processing and automated analysis.

Koios DS for Breast is a machine learning-based software that assists physicians in analyzing ultrasound images of breast lesions. It helps classify breast lesions into BI-RADS categories to support diagnostic accuracy, improve consistency between readers, and provide useful visual confidence indicators. The software processes selected regions of interest on ultrasound images and provides diagnostic support to clinicians.

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.

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.

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.

FerriSmart is a medical software that automatically analyzes MRI scans of the liver to measure iron concentration. This helps doctors diagnose and monitor patients with iron overload diseases, such as thalassemia or sickle cell disease, making treatment decisions more accurate and timely.

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.

Arterys MICA is a software platform designed to display, process, store, and transfer medical imaging data, including CT and MR images. It features modules specialized for cardiac and oncology workflows, providing quantitative analysis to aid clinicians in diagnosis. The software runs on standard computers via a web browser and supports enhanced image viewing and lesion evaluation for clinical decision support.