FDA Radiology AI Devices

The SpectralMD DeepView Wound Imaging System 2.0 is a medical imaging device that uses non-contact photoplethysmography (PPG) technology to capture color images showing blood perfusion in tissues. It helps clinicians assess blood flow in a variety of clinical settings, including wound healing, plastic surgery, and vascular surgery, by providing detailed images of microcirculation in healthy or injured skin.

The CardioLogs ECG Analysis Platform is a software tool that helps qualified healthcare professionals analyze ECG data to assess arrhythmias in adults. It supports uploading ECG recordings from various devices, processes them using a proprietary proprietary algorithm to detect heartbeats and rhythm abnormalities, and provides analysis results as an advisory support to clinicians. This cloud-based platform helps improve ECG interpretation efficiency and accuracy.

The syngo Application Software by Siemens is a versatile medical imaging software that allows clinicians to view, manipulate, and process medical images in real time. It supports diagnostic image review and various interventional procedures by providing image-guided navigation, fusion of ultrasound with fluoroscopy, and 3D visualization to improve anatomical orientation and procedural accuracy. This software helps clinicians streamline complex procedures and enhances treatment planning and control.

SmartTarget is a software system designed to assist physicians during image-guided prostate procedures by enhancing visualization. It processes 2D transrectal ultrasound images by performing 3D reconstruction and fusing these images with diagnostic scans like MRI or CT. This helps doctors accurately target and navigate instruments during biopsies, ablations, and other treatments, improving procedure precision and patient outcomes.

The UNiD Spine Analyzer is a web-based software designed to help healthcare professionals view and measure spine-related images, and plan orthopedic surgeries. It assists with measurements, surgical planning including osteotomies, and templating implants, enabling surgeons to prepare and validate plans for patient-specific spine implants.

The LungVision System is a medical imaging software that helps doctors navigate tools inside the lungs during procedures. It works by segmenting CT scan data and overlaying it on live X-ray images to guide catheter placement accurately, improving procedural safety and effectiveness.

AmCAD-UV is a software tool designed to analyze flow Doppler ultrasound images by classifying ultrasonic color intensity data into different pulsatile signals. It helps clinicians visualize and evaluate vascular pulsatility by providing color-coded images and trend charts of pulsatile signals, although it is not intended for primary diagnostic use by itself.

EnsoSleep is a software tool that uses AI algorithms to analyze sleep study data, including brain waves and breathing patterns, to help physicians evaluate sleep quality and diagnose sleep-related disorders such as sleep apnea. It automates scoring of sleep stages, detection of arousals, leg movements, and breathing events, improving efficiency while requiring clinician verification.

SIS Software is designed to help medical professionals such as surgeons, neurologists, and radiologists visualize and plan surgeries targeting brain structures, particularly the subthalamic nucleus. It uses machine learning and image processing to enhance standard MRI images and create patient-specific 3D models of brain anatomy, supporting safer and more precise stereotactic surgical procedures.

Quantib Brain 1.2 is a software tool that assists radiologists by automatically identifying and measuring different brain structures and white matter abnormalities from MRI scans. It provides visualizations and quantitative data to support evaluation and reporting, enabling better assessment of brain health over time by comparing multiple scans of the same patient.