World's first portable MRI system gets FDA's nod
USA: Magnetic resonance imaging (MRI) has revolutionized medicine, but access to MRI scanners is still a challenge. The U.S. Food and Drug Administration has given 510(k) clearance to the world's first' portable, low-cost, and low-field magnetic resonance (MRI) system. Hyperfine's Lucy point-of-care MRI will allow successful imaging of the patient's brains for evaluating stroke at their bedside.
This will do away with the current challenge of accessibility to the MRI machine. Typically, MRI machines 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. However, advances in low-field MRI have enabled the acquisition of clinically useful images using a portable device at the bedside.
The MRI system may become a safe and practical way to get accurate brain images at a patient's bedside, according to preliminary research to be presented at the American Stroke Association's International Stroke Conference 2020 – Feb. 19-21 in Los Angeles.
"We've flipped the concept from having to get patients to the MRI to bringing the MRI to the patients," said Kevin Sheth, M.D., senior author and chief physician, Division of Neurocritical Care and Emergency Neurology at Yale School of Medicine and Yale-New Haven Hospital in Connecticut. "This early work suggests our approach is safe and viable in a complex clinical care environment."
The study involved 85 stroke patients (46% women, age 18-96, 46% ischemic stroke, 34% intracerebral haemorrhage, 20% subarachnoid haemorrhage). They 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-centimetre opening of the MRI machine, and six patients experienced claustrophobia, factors which halted their test.
"We started this research several years ago because obtaining accessible, meaningful brain imaging for patients has been a major worldwide health care gap for decades," Sheth said. "The whole thing works because we are using low-field magnets to acquire brain images after a stroke."
Currently, patients must travel to the location of a high-field MRI device. However, advances in low-field MRI have enabled the acquisition of clinically useful images using a portable device at the bedside.
"High-field magnets are the cornerstone of commercial MRIs. The portable, low-field MRI could be used at hospitals that currently have a high-field MRI and in any other setting where an MRI is currently not available."
He added that the portable MRI devices will also decrease the need for a special power supply, cooling requirements, cost and other barriers that currently limit easy patient access
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.
"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," Sheth said.
Sheth said the next steps include scanning more patients, improving image quality, using the devices in multiple settings and using machine learning to extract as much meaningful information as possible.
About 510(k) Clearance
Section 510(k) of the Food, Drug, and Cosmetic Act requires device manufacturers who must register, to notify the FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified.