FDA Radiology AI Devices

The Swoop Portable MR Imaging System by Hyperfine, Inc. is a portable ultra-low field MRI device designed to image the internal structure of the head. It provides physicians with useful diagnostic images in environments where full diagnostic examination is not practical. The system uses deep learning reconstruction algorithms to improve image quality and is intended for use at the point of care, such as emergency rooms and intensive care units, enhancing access to MRI imaging in diverse clinical settings.

The Swoop Portable MR Imaging System by Hyperfine, Inc. is a portable, ultra-low field MR imaging device designed to produce images of the internal structures of the head. It uses deep learning algorithms to improve image quality by reducing noise and blurring, helping clinicians at the point of care obtain diagnostic information even when full diagnostic exams are impractical.

The Swoop Portable MR Imaging System by Hyperfine is a bedside portable MRI device designed to produce images of the internal structure of the head. It uses magnetic resonance imaging with advanced image reconstruction algorithms that include deep learning to enhance image quality by reducing noise and blurring. This helps clinicians obtain diagnostic images even when full diagnostic examination is not practical, aiding diagnosis at the point of care in facilities such as emergency and critical care units.

BrainInsight is an automated software that processes low-field MRI brain images to provide automatic labeling, spatial measurement, and volumetric quantification of brain structures. It produces annotated and segmented brain images with color overlays and detailed reports, helping clinicians assess brain anatomy and abnormalities efficiently, particularly using low-field MRIs.

The Swoop Portable MR Imaging System by Hyperfine is a bedside MRI device that allows clinicians to capture magnetic resonance images of the head without moving the patient. It utilizes advanced deep learning-based image reconstruction to improve image quality, reducing noise and blurring. This portable device helps provide timely diagnostic information in critical care settings where traditional MRI is difficult.

The Swoop Portable MR Imaging System by Hyperfine, Inc. is a bedside portable MRI device designed to produce internal head images using magnetic resonance imaging. It allows clinicians to perform imaging at the point of care when full diagnostic exams are not practical. Its AI-enabled reconstruction algorithm enhances image quality by reducing noise and blurring for multiple MRI sequences, helping physicians with diagnosis.

BrainInsight is a software product from Hyperfine, Inc. that automatically processes low-field MR brain images to label, segment, and measure brain structures. It provides physicians with annotated images, color overlays, and reports that help in evaluating brain anatomy and pathology more efficiently. The system is cloud-based and integrates with FDA-cleared PACS systems to seamlessly assist clinical workflows.

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.

The Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) System by Hyperfine, Inc. is a portable MRI device designed to provide bedside imaging of the brain. It uses advanced deep learning for image reconstruction to reduce noise and blurring, enabling clinicians to view internal head structures more clearly. This system facilitates quicker and more accessible brain imaging in various care settings, aiding in diagnosis without the need to transport patients to traditional MRI suites.