The FDA has approved 510 (k) clearance for the Hyperfine Research Inc. bedside Magnetic Resonance Imaging (MRI) system, the world’s first bedside MRI. The Hyperfine system is 20 times lower cost, 35 times lower power consumption, and 10 times less weight than today’s fixed conventional MRI systems.
Jonathan Rothberg, PhD and founder and chairman of Hyperfine Research, said the FDA clearance clears the way for device shipments this summer. Additionally, Hyperfine is working to develop artificial intelligence and deep learning software to reconstruct images and assist in diagnosis.
The Hyperfine point-of-care device represents multiple innovations in MRI design, architecture and workflow; more than 100 patents have been issued or are currently pending. The system is highly portable and wheels directly to the patient’s bedside, plugs into a standard electrical wall outlet, and is controlled via a wireless tablet such as an Apple iPad.
Dr. Khan Siddiqui, Hyperfine’s CMO, said it was designed to address the limitations of current MRI systems in order to make MRI accessible anytime, anywhere, to any patient.
“More than 40 years after its first use, MRI remains a marvel. Unfortunately, it also remains inaccessible. It’s time that MRI made the jump to point of need just like X-ray and ultrasound have before it,” he said. “Going beyond that, nearly 90 percent of the world has no access to MRI at all. With the FDA’s decision, we are now ready to rewrite the rules of MRI accessibility.”
In developing the system, Hyperfine performed thousands of brain scans including those within investigational partnerships at Yale New Haven University, Penn Medicine, Good Samaritan Hospital Long Island, New York Presbyterian Brooklyn Methodist Hospital, and Brown University, in addition to calling upon seminal work from the Martinos Center for Biomedical Imaging at Massachusetts General Hospital.
The FDA clearance includes head imaging for patients 2 years of age and older. Hyperfine is now accepting product pre-orders via hyperfine.io.
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.
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