FDA Radiology AI Devices

Bone VCAR is a software tool designed to assist clinicians in reviewing CT images that include the spine. It uses deep learning to automatically label vertebrae and provides optimized display settings to improve visualization and reporting efficiency across multiple care areas such as trauma and oncology.

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.

SIS Software version 3.3.0 is a medical imaging application that assists clinicians, including surgeons and neurologists, by enhancing and visualizing brain MRI images, specifically the subthalamic nucleus (STN). It uses AI and image processing techniques to create 3D models and supports image fusion and co-registration between MRI and CT scans to guide stereotactic surgical procedures more accurately.

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.

cmTriage is a software tool that uses artificial intelligence to analyze 2D digital mammograms and flags suspicious cases to help radiologists prioritize which exams to review first. It integrates with the Picture Archiving and Communication System (PACS) worklist but does not alter images or provide diagnostic results. cmTriage aims to improve the efficiency of breast cancer screening workflows by identifying potentially abnormal cases for quicker attention.

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 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.