FDA Radiology AI Devices

The syngo.via MI Workflows, including Scenium and syngo MBF, are Siemens software tools designed to assist radiologists by automating the processing of medical images, improving workflow efficiency and potentially supporting diagnosis through advanced image analysis.

The RadiForce RX570 and RX570-AR are high-resolution color LCD monitors designed for viewing medical images, including mammography and digital breast tomosynthesis. These monitors provide calibrated display modes ensuring consistent, high-quality images for radiologists, aiding in accurate image review, analysis, and diagnosis. The devices come with quality control software to support reliable monitor calibration and performance verification.

NeuroMatch is a cloud-based medical software developed by LVIS Corporation to assist neurologists in reviewing and analyzing EEG recordings by automatically detecting potential seizures and epileptiform spikes. It employs advanced AI algorithms to highlight important EEG events, helping clinicians interpret brain activity more efficiently without providing a direct diagnosis.

The Dreem 3S is a wearable headband device that records brain electrical activity (EEG) and movement data during sleep. It uses AI algorithms based on neural networks to automatically analyze this data and produce detailed sleep stage reports for adults. This helps clinicians assess sleep patterns and disturbances remotely in home or healthcare environments.

The Gating Reflector Block is a reusable hardware accessory used during radiotherapy treatment and imaging to track patient respiratory motion. It helps monitor breathing patterns by reflecting infrared light detected by cameras in compatible radiation therapy and imaging systems, improving motion management during imaging or treatment delivery.

The Natus BrainWatch System is a portable EEG monitoring device that records and visually presents EEG signals to assist trained medical personnel in neurological diagnosis for patients aged 2 years and older. It features a disposable headband with integrated electrodes, wireless connectivity, and cloud storage, enabling rapid and convenient EEG monitoring in healthcare settings.

Change Healthcare Stratus Imaging PACS is a cloud-based software system that manages and processes medical images to assist healthcare professionals in diagnosing and interpreting medical images. It offers features like image manipulation, enhancement, and 3D/4D visualization through a zero-footprint browser-based viewer. It supports clinicians by providing tools for reviewing and analyzing images acquired from DICOM-compliant devices, improving workflow with integrated reporting tools and secure access from clinical or remote locations.

Frontier X Plus is a wearable ECG event recorder that monitors heart rhythms by capturing single-channel ECG signals via a chest strap. It automatically analyzes the ECG data using an embedded algorithm to detect arrhythmias such as atrial fibrillation, bradycardia, and tachycardia. The device helps clinicians monitor and diagnose heart conditions in adult patients, particularly those with suspected or known cardiac issues, by storing and transferring ECG data for physician review.

Hybrid Viewer is a software application used in nuclear medicine and radiology that processes and analyzes imaging data to help clinicians assess physiological or pathological states. It supports predefined workflows optimized for specific nuclear medicine studies and allows quantitative analysis to assist clinical management, though it does not replace visual assessment.

The Affera Integrated Mapping System with the Impedance Localization Patch Kit is a computer-based diagnostic tool designed to assist clinicians in catheter-based cardiac electrophysiological mapping. It provides real-time visualization of catheters, maps cardiac signals, and helps guide therapeutic interventions by displaying detailed cardiac maps and signals, enhancing cardiac procedure accuracy and patient care.