FDA Radiology AI Devices

The SIGNA Premier by GE Healthcare is a whole-body magnetic resonance imaging (MRI) system designed to produce high-resolution diagnostic images of many body parts including the head, spine, joints, and heart. It incorporates a new AI-powered software feature called AIR Recon DL that improves image quality by enhancing signal-to-noise ratio and sharpness, while allowing for shorter scan times. This helps clinicians get clearer images faster, supporting better diagnosis and patient care.

AIMI-Triage CXR PTX by RADLogics is an FDA-cleared AI software that helps hospital radiologists prioritize adult chest X-rays that might show moderate to large pneumothorax. It analyzes chest X-rays and flags urgent cases for quicker review, improving workflow and patient care by notifying radiologists of possible urgent findings without replacing full diagnosis.

Rapid ICH is an AI-powered clinical software tool designed to help hospital radiology workflows by automatically analyzing non-contrast head CT scans to detect suspected intracranial hemorrhage. It provides alerts and compressed preview images to clinicians through PACS, email, and a mobile app to prioritize urgent cases and aid timely diagnosis and treatment decisions.

KOSMOS is a handheld diagnostic ultrasound system by EchoNous, Inc. that integrates ultrasound imaging, electrocardiogram (ECG), and digital auscultation in one device. It is designed for clinical assessment of cardiac, pulmonary, abdominal, and vascular systems by providing synchronized images, sounds, and waveforms. This facilitates enhanced diagnosis and guided interventions for healthcare professionals in various clinical settings.

Arterys MICA is a medical diagnostic software that processes and analyzes medical imaging data, primarily MR and CT scans. It includes AI modules that assist clinicians in quantifying heart function and detecting, evaluating, and tracking lesions for oncology purposes. The software supports trained healthcare professionals by providing quantitative data and visualization tools to aid diagnosis and treatment follow-up.

MammoScreen is an AI-based software that assists physicians in interpreting full-field digital mammograms (FFDM) by identifying suspicious breast lesions such as soft tissue lesions and calcifications. It provides marks on the mammogram images alongside a suspicion score to help detect potential breast cancer, supporting radiologists during their reading process to improve cancer detection without replacing clinical judgment.

Hepatic VCAR is a medical software designed to assist clinicians in analyzing liver CT scans by providing automated and editable 3D segmentation of the liver, liver lesions, and hepatic artery. It uses deep learning algorithms to improve accuracy, helping to assess liver morphology and changes over time, thereby facilitating faster and more precise liver evaluations.

AI-ECG Tracker is software designed to assist healthcare professionals in hospitals by automatically analyzing ambulatory ECG data to detect and assess cardiac arrhythmias in adults. It processes ECG waveforms, detects specific ECG features like QRS complexes and ectopic beats, measures intervals and heart rate, and provides advisory interpretations to support clinical diagnosis of arrhythmias, but not as the sole diagnostic tool.

Viz ICH is an AI-based software tool designed to analyze non-contrast CT scans of the brain for signs of intracranial hemorrhage (ICH). When the software detects suspected ICH, it sends notifications to neurovascular or neurosurgical specialists, helping speed up patient care by alerting clinicians early. The system includes a backend server for image processing and a mobile app for reviewing images in a non-diagnostic way for quick assessment and communication.

Al-Rad Companion (Musculoskeletal) is AI-powered software designed to analyze CT images of the spine. It supports clinicians by automatically segmenting and labeling vertebrae, measuring vertebral heights, and calculating the mean Hounsfield unit values within vertebrae, aiding in musculoskeletal disease evaluation and assessment.