FDA Radiology AI Devices

SIS Software Version 3.6.0 is an advanced medical imaging application designed to assist neurosurgeons, neurologists, and radiologists by processing MRI and CT scans to create detailed 3D models of brain structures, particularly the subthalamic nuclei. It uses machine learning to enhance images, aiding in the visualization and planning of stereotactic brain surgeries, thereby improving surgical accuracy and patient outcomes.

BrainScope TBI is a portable, non-invasive device that assists clinicians in evaluating patients with mild traumatic brain injury and concussion by analyzing brain electrical activity through EEG along with cognitive tests and clinical symptoms. It helps identify the likelihood of structural brain injury and assesses brain function, supporting decisions about the need for further imaging like CT scans.

AI-Rad Companion (Cardiovascular) is an AI-powered software that analyzes previously acquired CT chest images to segment the heart and aorta, quantify coronary calcium, and measure aortic diameters. It assists clinicians by providing quantitative and qualitative cardiovascular assessments to support diagnosis and evaluation in emergency, specialty, and general practice care.

The Clarius Ultrasound Scanner is a portable, software-controlled ultrasound system that connects wirelessly to iOS or Android devices to provide high-resolution, real-time diagnostic ultrasound and Doppler imaging. It supports multiple clinical applications such as abdominal, cardiac, musculoskeletal, fetal, and procedural guidance, helping clinicians perform ultrasound imaging conveniently in diverse healthcare settings.

D2P is a software tool developed by 3D Systems that processes medical imaging data (DICOM) to create 3D segmentations and physical models. It assists clinicians in surgical planning by allowing the generation of accurate physical replicas of anatomical regions from imaging data, supporting diagnosis and treatment decisions in cardiovascular, craniofacial, gastrointestinal, genitourinary, neurological, and musculoskeletal areas.

The Zio XT and Zio AT ECG Monitoring Systems by iRhythm Technologies, Inc. analyze continuous ECG data collected via wearable patches and generate detailed reports on cardiac events. These systems help clinicians diagnose heart rhythm abnormalities by providing comprehensive, beat-to-beat ECG analysis over long monitoring periods for patients with or without symptoms.

Biovitals Analytics Engine is a cloud-based software that analyzes continuous biometric data from sensors measuring heart rate, respiratory rate, and activity in ambulatory patients. It creates a personalized biometric signature for each patient and computes a Biovitals Index to track changes in vital signs over time, providing clinicians with additional insight for routine monitoring without replacing traditional vital sign monitoring.

HeartFlow FFRct Analysis is a software tool that uses AI to analyze previously acquired coronary CT images (CT DICOM data). It creates a 3D computer model of the coronary arteries and simulates blood flow and pressure to help clinicians evaluate coronary artery disease. This aids in diagnosis and treatment planning by providing functional insights beyond traditional imaging.

Critical Care Suite is an AI-powered software by GE Medical Systems designed to analyze frontal chest X-ray images and detect pneumothorax, a potentially life-threatening condition. It flags suspicious images in the image management system to help radiologists prioritize urgent cases, improving workflow efficiency and patient care. The software runs seamlessly without delaying image processing and helps reduce the report turnaround time for critical chest X-rays.

aBSI is a software-only medical device designed to quantitatively assess and analyze skeletal disease burden on bone scans from nuclear medicine imaging. It helps healthcare professionals by automatically detecting and quantifying lesions to support clinical decision-making, particularly in oncology, by measuring disease extent in the skeleton.