FDA Radiology AI Devices

The Swoop Portable MR Imaging System is a bedside portable MRI device designed for producing images of the internal structure of the head when full diagnostic exams are not feasible. It uses advanced AI-based image reconstruction algorithms to enhance image quality with reduced noise and blurring, aiding clinicians in diagnosis at the point of care, such as emergency rooms or critical care units.

AIR Recon DL is a deep learning-based software feature for GE Healthcare MRI systems that improves image quality by reducing noise and ringing artifacts in MRI images. It helps clinicians by enabling shorter scan times without losing image clarity, thus improving patient comfort and diagnostic accuracy across multiple anatomies and MR field strengths.

The Voluson Expert 22, 20, and 18 are advanced ultrasound imaging systems designed for various clinical applications such as OB/GYN, abdominal, cardiac, and musculoskeletal imaging. They offer high-performance real-time 3D/4D imaging, Doppler modes, elastography, and incorporate AI software tools to assist clinicians in image analysis and workflow improvement, helping improve diagnostic accuracy and efficiency in hospitals and medical clinics.

BriefCase by Aidoc Medical, Ltd. is an AI-based software that helps hospitals quickly identify and prioritize urgent head CT angiography scans with possible M1 Large Vessel Occlusion. It analyzes images and sends notifications with preview images to clinicians, enabling faster triage without replacing standard image interpretation.

The Atrial Fibrillation History Feature is a software application designed to analyze pulse rate data from Apple Watch sensors to detect episodes of irregular heart rhythm indicative of atrial fibrillation (AFib). It provides users with estimates of the amount of time spent in AFib over past periods and visualizes this alongside lifestyle data to help users understand the impact of their behavior on their condition. It assists patients in monitoring AFib burden over time but is not meant to replace traditional diagnosis or treatment methods.

Rayvolve is an AI-powered software tool that helps radiologists and emergency physicians detect fractures on X-rays of the musculoskeletal system. It analyzes various standard radiographic views of bones like ankle, clavicle, elbow, hip, knee, and more, providing accurate fracture detection to support clinical decision-making.

Rapid LVO is a software device designed to analyze CT angiography images of the head to help healthcare providers identify suspected large vessel occlusions quickly. By flagging possible cases of ICA or MCA-M1 occlusion and providing notifications with preview images, it supports faster triage and prioritization of medical images, aiding timely clinical decision-making in stroke care.

SwiftMR is a software device that automatically enhances MRI images by reducing noise and increasing image sharpness using deep learning algorithms. It supports brain, spine, and musculoskeletal MRI images and integrates with existing PACS systems to improve diagnostic image quality without interrupting clinical workflow.

BriefCase by Aidoc Medical is an AI-powered software that analyzes non-enhanced head CT images to identify potential intracranial hemorrhage. It assists clinicians by flagging suspect cases and sending notifications with preview images to help prioritize patient care workflow. It operates alongside standard imaging interpretation without altering original medical images.

Rapid PE Triage and Notification (PETN) is an AI-powered software that analyzes CT pulmonary angiography scans to detect and notify clinicians of suspected central pulmonary embolism cases. It assists hospital networks and clinicians by prioritizing patient workflows and flagging positive findings, helping improve timely diagnosis and treatment without altering original medical images.