FDA Radiology AI Devices

EchoConfidence (USA) is an AI-powered software that helps clinicians analyze transthoracic echocardiogram images. It automatically classifies views, segments cardiac structures, measures cardiac function, and performs Doppler assessments, improving the efficiency and accuracy of cardiac image interpretation for adults and adolescents.

Synapse PACS (7.5) by FUJIFILM Healthcare Americas Corporation is a web-based software application designed to manage, display, and process medical images from various modalities. It provides advanced tools such as measurements, regional segmentation, 3D volume rendering, fusion, and structured report generation to support clinicians like radiologists and cardiologists in reading, interpreting, and planning patient care efficiently.

PIUR tUS inside is a medical device that enhances standard 2D ultrasound devices by generating three-dimensional (3D) tomographic ultrasound volumes of the thyroid. It assists physicians in diagnosing thyroid nodules by providing volumetric information, segmentation, and quantification of sonographic characteristics. This device operates directly on compatible ultrasound scanners, integrating sensor data to create 3D images that support clinical decision-making as an add-on to regular ultrasound imaging.

The Affirm 800 is a surgical imaging device that helps neurosurgeons visualize blood flow and vessel patency in the brain during operations. It works by using near-infrared light to activate a fluorescent dye (Indocyanine Green) injected into the bloodstream, allowing surgeons to see detailed images of cerebral vessels on a 3D monitor in real time. This aids in assessing occlusions and blood flow in vessels, improving surgical outcomes.

The Dental CBCT X-ray System by Yian Medical Technology is a dental imaging device that produces 2D panoramic, cephalometric images, and 3D cone-beam CT images of the dental, oral, and maxillofacial region. It aids healthcare professionals in diagnosing adult and pediatric patients, providing detailed digital X-ray images for dental and oral care.

The eMotus Respiratory Motion Management System by EmpNia Inc. helps monitor and record patients' breathing patterns to improve the accuracy of CT diagnostic imaging and radiation therapy. By tracking respiratory motion, it aids clinicians in synchronizing image acquisition and radiation delivery, reducing motion-related artifacts and improving treatment precision. The device uses optical fiber sensors attached to the patient's chest or abdomen to generate a respiratory waveform and gate signals that help coordinate imaging and therapy devices.

The Philips iCT CT System is a computed tomography scanner designed for diagnostic imaging of the head, body, cardiac, and vascular regions. It produces detailed cross-sectional images by reconstructing X-ray data taken from multiple angles, aiding clinicians in diagnosing a range of conditions. The system offers updated hardware and software improvements for enhanced image quality, cybersecurity, and usability without altering its core imaging capabilities.

RTM Sense is a wearable respiratory monitoring system that continuously tracks breathing in adult patients by analyzing sounds from airflow in the trachea. It wirelessly transmits data to a tablet, where a proprietary software algorithm analyzes and displays respiratory rate, helping clinicians monitor breathing as an adjunct to other clinical information.

AISight Dx is a software-only, web-based digital pathology image viewing and management system designed to aid pathologists in viewing, interpreting, and managing digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It supports images from scanners such as the Hamamatsu NanoZoomer S360MD and Leica Aperio GT 450 DX. The software allows pathologists to zoom, pan, measure, and annotate whole slide images to assist in primary diagnosis while ensuring image quality through built-in quality controls.

The Neuralytix iD3 System is a surgical nerve stimulator and locator that helps surgeons find and monitor motor nerves during surgery by measuring muscle responses to electrical stimulation. It uses mechanomyographic signals to assess nerve function in real-time, enabling safer and more effective surgical interventions involving nerve mapping and monitoring.