World’s First Portable MRI Cleared by FDA

Hyperfine
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Magnetic resonance imaging (MRI) has revolutionized medicine, but MRI scanners are so demanding that access to them is still a challenge.

MRI machines typically require specially built rooms with magnet quench vent pipes, entry systems that check people for metals attracted to magnets, and specific protocols to ensure safety. Patients, therefore, have to be brought to the MRI scanners rather than the other way around.

This is about to change in many cases, as Hyperfine, a company with offices in New York City and St Guilford, Connecticut, won FDA clearance for the first MRI scanner that can be wheeled to the patient bedside.

Hyperfine’s Lucy point-of-care MRI is intended for scanning the head, neck, as well as the extremities, in just about any clinical setting. This can be of particular use in emergency rooms, intensive care units, and in facilities that currently don’t have access to a conventional clinical MRI.

It’s not exactly light, weighing in at 1,400 lbs (635 Kg), but it’s an order of magnitude lighter than a conventional MRI. A motorized wheel array on the bottom makes it quite manageable to drive the scanner from room to room without actually having to push it manually.

The Lucy uses low-field magnets that are safe around other equipment and it runs from a standard wall power outlet, making it easy to use in almost any hospital room.

Eighty-five stroke patients (46% women, age 18-96, 46% ischemic stroke, 34% intracerebral hemorrhage, 20% subarachnoid hemorrhage) received bedside, low-field MRI within seven days of symptom onset. The exam time averaged about 30 minutes, and most patients were able to complete the entire exam. However, five patients could not fit into the 30-centimeter opening of the MRI machine, and six patients experienced claustrophobia, factors which halted their test.

In addition, the low-field, bedside MRI scanner did not interfere with other equipment, and metals did not need to be removed from the room. No significant adverse events were reported.

World’s First Portable MRI Cleared by FDA
 

The results of a clinical study using the new MRI will be presented this week at the American Stroke Association’s International Stroke Conference 2020, but the American Heart Association already provides some details.

 

Hyperfine Point-of-Care MRI System