by Gus Iversen
, Editor in Chief | December 23, 2020
From the November 2020 issue of HealthCare Business News magazine
Hyperfine gets FDA nod for world's first portable bedside MR system
In February, Hyperfine received FDA approval for the world’s first bedside MR system
, creating new possibilities for hospitals seeking point-of-care imaging with a system the company says is 20 times cheaper, 10 times lighter and consumes 35 times less power than fixed conventional MR solutions.
The system, which is equipped with a .064 Tesla magnet, requires no shielding. It was developed with the nearly 90% of the world lacking access to MR in mind, but may also prove beneficial for a variety of patients receiving care in places where conventional MR is already available.
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"In hospitals, the first applications most people think of is pediatrics and avoiding the ionizing radiation of CT," Chris Ward, head of marketing for Hyperfine, told HCB News. "Another is intensive care where MR would be used if only it were readily accessible for some of the sickest, most fragile and hard-to-transport patients in the hospital."
Prior to its approval by the FDA, thousands of scans were performed as part of investigational partnerships at Yale New Haven University, Penn Medicine, Good Samaritan Hospital Long Island, New York Presbyterian Brooklyn Methodist Hospital, and Brown University.
In September, a team at Yale New Haven published research showing the scanner found evidence of ischemic stroke, hemorrhagic stroke, subarachnoid hemorrhage, traumatic brain injury, and brain tumors in patients who showed signs of neurological symptoms. It also was used to analyze 20 patients with severe COVID-19 symptoms, many of whom were too sick to be moved to an MR suite for a neurological diagnosis. Eight were found to have neurological abnormalities.
Hyperfine unveiled the system at the 2019 RSNA annual meeting.