Guilford, Conn.-based Hyperfine Research Inc. has received the U.S. FDA’s nod for a bedside magnetic resonance imaging (MRI) system and is eyeing this summer for shipments. The portable system can be wheeled directly to the patient’s bedside and plugs into a standard electrical wall outlet. In addition, it is controlled via a wireless tablet, such as an Apple Ipad.
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 alternative methods.
The FDA 510(k) clearance includes head imaging for patients 2 years of age and older. Of note, the company emphasized its offering’s lower cost and power consumption. It also weighs less than fixed conventional MRI systems. The company previously has said that its offering is ultra-compact, coming in at 3 feet wide and 5 feet tall.
Because of all these attributes, the company hopes to make MRI, which has been around more than 40 years, more accessible “It’s time that MRI made the jump to point of need just like X-ray and ultrasound have before it,” said Khan Siddiqui, Hyperfine’s chief medical officer. “Going beyond that, nearly 90% 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.”
To get to this point, the company 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. It also relied on work from the Martinos Center for Biomedical Imaging at Massachusetts General Hospital.
Yale New Haven Hospital was the first to use the Hyperfine system on patients, as part of a two-year study in conjunction with the American Heart Association. "The MRI systems we currently use around the world require a strict, limited access environment due to their high-field magnet design," Kevin Sheth, professor of neurology and neurosurgery, said last year when the collaboration between the parties was unveiled. He added that the accessibility offered by the portable MRI scanner could permit multiple exams over days or even hours.
While the FDA’s decision relates to use with the brain, the extremities, such as feet, hands and knees, are another potential application for the smaller MRI device.
“Nearly six years ago, a dream to create a portable, affordable MRI system was born. We assembled an astounding team, and they took the 10 million-fold improvement in computing power since MRI was invented and the best of the billions invested in green electronics and built something astonishing, something disruptive,” said Jonathan Rothberg, founder and chairman of Hyperfine Research.
For its part, Toronto-based Synaptive Medical Inc. has developed its Evry imaging system. It is the company’s first MRI product and scheduled for delivery this year to Halifax, Nova Scotia-based Dalhousie Medical School’s hospital emergency department. It is not cleared by the FDA, but Evry is designed to overcome many of the challenges of cost effectiveness, and workflow optimization to support POC MRI imaging.
The company reported in December that it had completed a round of a new preferred equity investment, totaling $25 million. The investment was led by Linamar Corp., which also entered a manufacturing agreement with Synaptive, and Audible Capital Corp., an existing investor.
In early 2019, Ottawa and the Nova Scotia government revealed plans to spend nearly CA$2 million (US$1,520,000) over three years to make a broad business case for a new neuroimaging system developed by Synaptive.