Artificial Intelligence Add-On for `World’s First` Portable MR Imaging System Receives FDA Clearance

Hyperfine Research, Inc. (Guilford, CT, USA) has received 510(k) clearance from the US FDA for its deep-learning image analysis software that measure brain structure and pathology in images acquired by the Swoop Portable MR Imaging 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. 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,” said 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.”

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Hyperfine Research, Inc.