‘World's first’ bedside MRI machine scores FDA clearance, eyes summer rollout

The U.S. Food and Drug Administration has given its blessing to what inventors believe to be the world’s first portable MRI machine, officials announced Wednesday.

Hyperfine Research said it hopes to begin shipping its new point-of-care imaging tool this summer, which carries a fraction of the cost and weight of a traditional machine. Its affixed to wheels, plugs into a standard socket and radiologists can control it with a wireless tablet, the Connecticut-based company said in an announcement.

“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,” Khan Siddiqui, MD, a radiologist and Hyperfine’s chief medical officer, said in a statement. “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.”

The FDA clearance covers head imaging of patients 2 years of age or older. Hyperfine said it has already tested the scanner on thousands of patients through partnerships at institutions including Yale, Penn and Brown universities.

The American Stroke Association is also set to highlight one trial of this technology at its international conference, which kicks off of Feb. 19 in Los Angeles. In its own announcement, the ASA noted that 85 stroke patients received this low-field, bedside MRI scan within seven days of onset. On average, each exam lasted half an hour, with most tests completed. Five individuals, however, could not fit into the 30-centimeter opening and six experienced claustrophobia.  

Scientists reported no adverse events and next plan to scan additional patients and work to further improve image quality, the ASA said.

“There’s a lot of work to do, however, we’ve cracked the door open for bringing this technology to any setting, anywhere. In rural settings, urban advanced hospitals and in remote villages in areas of the world where it’s hard to get an MRI—not anymore,” Kevin Sheth, MD, senior author of the study and Yale’s chief physician in the Division of Neurocritical Care and Emergency Neurology, said in a statement.