The Food and Drug Administration (FDA) has granted 510(k) clearance to the Hyperfine system (Hyperfine Research), a bedside magnetic resonance imaging (MRI) system. The FDA clearance includes head imaging for patients 2 years of age and older.
The Hyperfine system can be moved on wheels directly to the patient’s bedside and weighs significantly less than other MRI systems (1400 Ibs). The point-of-care device can be plugged into a standard wall outlet and is operated from a wireless tablet.
In developing the system, Hyperfine performed thousands of brain scans at Yale New Haven University, Penn Medicine, Good Samaritan Hospital Long Island, New York Presbyterian Brooklyn Methodist Hospital, and Brown University. Beyond the brain, the Company is investigating the use of Hyperfine for imaging related to spinal cord compression, diabetic foot disease, and musculoskeletal trauma.
“It’s time that MRI made the jump to point of need just like X-ray and ultrasound have before it,” said Dr Khan Siddiqui, Hyperfine’s Chief Medical Officer. The device will be demonstrated at upcoming medical conferences. Shipments are expected to begin this summer (2020).
For more information visit hyperfine.io.