FDA Radiology AI Devices

The EXTRON series (EXTRON 3, EXTRON 5, EXTRON 7) are mobile fluoroscopic X-ray systems that provide high-quality, real-time X-ray images to support clinicians during emergency injury treatment, orthopedic surgery, neurosurgery, and other interventions. The system includes advanced image processing capabilities and enables saving and transferring images to hospital PACS, improving diagnosis and workflow in surgical settings.

Viz Subdural+ is an AI-powered software that automatically analyzes head CT scans to measure subdural collections and midline shift. It helps clinicians by providing automated volume and width measurements of subdural collections, improving efficiency and accuracy in brain injury assessment.

Cirrus Resting State fMRI Software is a medical imaging software that processes resting state functional MRI data to generate brain maps showing motor, language, and vision networks. These maps assist clinicians such as surgeons and radiologists in visualizing functional areas of the brain non-invasively, aiding in pre-surgical planning and clinical decision-making.

The Empatica Health Monitoring Platform is a wearable device system that monitors various physiological parameters such as pulse rate, respiratory rate, oxygen saturation, and skin temperature by collecting sensor data, which is analyzed using AI algorithms. It enables healthcare professionals to review patients' physiological data remotely and retrospectively to assess their condition, improving patient monitoring in home healthcare settings.

BrightHeart View Classifier is a cloud-based AI-powered software designed to analyze 2D fetal ultrasound images and video clips to automatically identify and classify standard fetal heart views. It assists trained healthcare professionals in acquiring and interpreting fetal heart ultrasound exams in the second and third trimesters by providing annotated outputs and validating whether scanning protocols are met, improving diagnostic workflow and consistency.

The Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters are reprocessed ultrasound catheters used in cardiac electrophysiology procedures. They provide real-time 2D ultrasound imaging and 3D location sensing inside the heart and great vessels to help clinicians visualize anatomy and other procedural devices during interventions.

Sonic DL is a software feature for GE HealthCare MR systems that uses deep learning algorithms to reconstruct MR images from highly under-sampled data, enabling faster image acquisition and maintaining diagnostic quality. It supports multiple MR field strengths and is used across various anatomies, including cardiac, brain, spine, musculoskeletal, abdomen, pelvis, and breast imaging, helping clinicians obtain high-quality MR images more quickly.

TechLive is a software application designed to enable healthcare professionals to remotely access and control medical imaging devices in real-time for image acquisition, assistance, review, and training. It supports multiple imaging modalities and fosters collaboration among clinical staff across different locations, improving operational support and training without being intended for diagnostic use.

UroNav 4 is a medical image processing and navigation system that helps clinicians plan and guide biopsy and soft tissue ablation procedures, especially for the prostate gland. It fuses and registers 2D and 3D ultrasound images with other imaging modalities like MRI to provide real-time image guidance using electromagnetic tracking. This enhances precision in navigating interventional instruments, improving clinical outcomes in minimally invasive procedures.

The Paradigm System by Proprio, Inc. is a surgical navigation system that helps surgeons precisely position spinal instruments during posterior spine surgeries. It combines preoperative CT-based 3D models of the spine with real-time camera imaging of the surgical site to enable accurate instrument placement, improving surgical accuracy and patient outcomes.