FDA Radiology AI Devices

Oxehealth Vital Signs is a software medical device that uses video footage from fixed-installation cameras to noninvasively measure pulse rate and estimated breathing rate through analysis of chest wall movements. It is designed for use in single occupancy rooms within hospitals and secured environments where healthcare professionals periodically monitor patients. This technology enables spot checks of vital signs without physical contact, supporting clinical monitoring while minimizing patient disturbance and infection risk.

BriefCase by Aidoc Medical, Ltd. is an AI-powered software that analyzes contrast-enhanced chest CT scans to help hospital specialists prioritize and triage cases showing possible incidental Pulmonary Embolism. It provides notifications with compressed preview images for early attention but does not replace standard diagnostic review, working alongside existing workflows to speed up urgent case identification.

ClariPulmo is a software tool designed to analyze lung CT images. It helps doctors by automatically segmenting the lungs and quantifying areas of low and high attenuation in the lung tissue. It includes AI-based features like deep learning segmentation, denoising, and kernel normalization to improve image quality and quantification, especially for low-dose CT scans. This software supports clinical assessment of lung abnormalities by providing color-coded images and quantitative reports.

The EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System is an AI-powered software that automatically measures the cardiothoracic ratio from chest X-ray images in the posterior-anterior view. It helps physicians by automatically calculating a key heart size measurement, supporting clinical assessments in hospitals and clinics for adult patients.

BriefCase is a software device that uses artificial intelligence to analyze chest X-ray images for signs of pneumothorax. It notifies trained medical specialists of suspected positive cases via a desktop app to help prioritize patient care. The software works alongside standard clinical workflows without altering the original images or diagnostic process.

ClearRead Xray Pneumothorax is an AI-powered software tool designed to analyze adult chest X-rays and identify signs of pneumothorax larger than 5 mm. It functions as a triage system that notifies radiologists about suspected urgent cases, helping prioritize the review workflow but not replacing diagnostic interpretation.

Annalise Enterprise CXR Triage Pneumothorax is a software tool that uses artificial intelligence to analyze adult chest x-rays for signs of pneumothorax and tension pneumothorax. It assists trained clinicians by automatically prioritizing and triaging cases in their worklist, enabling faster attention to urgent findings. The device integrates with hospital imaging systems and helps optimize workflow without replacing clinical judgment.

qXR-BT by Qure.ai Technologies is an AI-powered software designed to analyze chest X-ray images to help physicians confirm the position of breathing tubes. It generates secondary digital images with highlighted tube tips and anatomical landmarks, providing valuable adjunctive information during radiological assessment.

HealthPPT is an AI-powered software tool that helps radiologists by automatically detecting signs of pneumoperitoneum in adult frontal chest X-rays. It prioritizes urgent cases by notifying the radiology workstation with a low-resolution preview image, enabling faster review of potentially critical findings. The device works alongside standard workflows without altering original images and does not itself diagnose the condition, but aids clinical assessment by highlighting suspicious cases for prompt review.

Al-Rad Companion (Pulmonary) is an AI-powered software by Siemens that processes CT images of the lungs to assist clinicians in quantitatively and qualitatively analyzing lung diseases. It segments lungs and lobes, detects lung lesions and areas of abnormal tissue density, and provides measurements to support radiologists and physicians in emergency, specialty, and general care settings. This helps streamline and improve lung disease evaluation.