FDA clears deep learning application to support image interpretation with Hyperfine’s Swoop Portable MR Imaging System
January 15, 2021
Guilford, CT, Jan. 14, 2021 (GLOBE NEWSWIRE) -- Hyperfine Research, Inc. has received 510(k) clearance from the US FDA for its deep-learning image analysis software. These Advanced AI Applications measure brain structure and pathology in images acquired by the category-defining Swoop™ Portable MR Imaging System through tools featuring automatic measurement of ventricular volume, brain extraction, brain alignment, and midline shift -- a clinical measure of brain injury.
Included as part of Swoop™’s standard software package, Advanced AI Applications work with Swoop™ to transform the system into a true bedside clinical decision support platform for evaluating brain health and injury. In just minutes after Swoop™ scanning, Advanced AI Applications analyze and return annotated and segmented brain images, providing clinicians of all levels of expertise with quantitative markers for decision support and immediate feedback for diagnostic insight.
“With this powerful tool now built into the Swoop™ system, we are making MR imaging not only accessible at the bedside but making it easier for providers to move quickly from scan to a recommended course of treatment,” commented Dr. Khan Siddiqui, Chief Medical Officer of Hyperfine. “The data provided by Hyperfine's deep learning software will liberate users of our MR technology by providing simple, accessible information in just minutes.”
ABOUT MR IMAGING and the Swoop™ Portable MRI System
Magnetic Resonance Imaging (MRI) uses a magnetic field, radio waves, and a computer to produce detailed pictures of the body's internal structures that are clearer, more detailed, and more likely in some instances to identify and accurately characterize disease than other imaging methods. However, fixed MRI systems can be inconvenient and inaccessible for providers and patients, particularly when time is critical. Transport to the MR suite demands complicated scheduling coordination, moving patients, and, often, 4- to 6-hour patient backlogs — all of which compromise the utility of MRI as a diagnostic tool in time-sensitive settings, such as intensive care units and emergency rooms. Furthermore, high capital investments, electrical power needs, and significant maintenance requirements present barriers to adoption across all populations, acutely so for developing countries and rural geographies.
Hyperfine’s Swoop™ Portable MR Imaging System is designed to address the limitations of current imaging technologies and make MRI accessible anytime, anywhere, to any patient. Swoop™ wheels directly to the patient’s bedside, plugs into a standard electrical wall outlet, and is controlled by an Apple iPad®. Designed as a complementary system to traditional MRIs at a fraction of the cost, images that display the internal structure of the head are captured by Swoop™ at the patient’s bedside, with results in minutes, enabling critical decision-making capabilities across a variety of clinical settings.
About Hyperfine Research
Hyperfine lives to make MR imaging available to everyone. The Swoop™ Portable MR Imaging System is the result of a total rethink of MR’s potential in the healthcare landscape. What if MR imaging didn’t require a dedicated suite, extensive training or expensive upkeep? Let’s use the wonders of high-field MRI for the appropriate patients, and deploy Swoop™ at the point-of-care for everyone else. Hyperfine received market-ready FDA clearance for its portable MR imaging for the brain and head of patients of all ages in August 2020.