由 John R. Fischer
, Senior Reporter | May 27, 2020
The FDA has given United Imaging Healthcare the nod for its uMR OMEGA MR scanner, a system equipped with the world’s first ultra-wide 75-cm bore.
The system is set to make its world debut in the U.S. and is designed to accommodate a wide range of patients, including much of the 40% of the U.S. population with obesity and the 2.5% afflicted with claustrophobia.
"Here, many patients don’t have access to critical diagnoses using MR, either because of body habitus (the U.S. has the largest obesity population in the world), or because of patient intolerance due to claustrophobia," Jeffrey Bundy, Ph.D., CEO of United Imaging, told HCB News. "Our estimates suggest that as many as one in 20 could have limited access to MR because of issues like these. That’s a large number of underserved patients, but United Imaging is heavily invested in opening up broader access to advanced imaging patients here in the U.S. and addressing the unique challenges of our healthcare system."
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In addition to its bore, the system is equipped with 683 lbs of table capacity and for the first time, a larger 60 x 60 x 50 cm field of view. These components together make the scanner specifically designed for bariatric patients.
The scanner improves patient comfort by providing more space and lighting to make MR more friendly for those who are claustrophobic and anxious.
It also can be used to scan children and seniors faster, especially those who cannot stay still for long periods of time. Providers are able to offer new services with it, including acute imaging in the emergency room with an ultra-fast five-minute stroke protocol and cardiac imaging with a single breath-hold to reduce the number of scans required.
"No machines to this point, however, had been designed to care for the largest of patients — and in challenging economic times, buyers of capital equipment need to be sure each purchase can serve the most needs possible and can differentiate them from their competitors," said Bundy. "Thus, the uMR OMEGA provides a great full-coverage option. It also benefits normal patients for everything from routine off-center imaging and improved fat saturation, to the most demanding applications like spectroscopy."
The approval of uMR OMEGA follows the deployment last month
of transportable CT scanners with 80- to 128-slice capabilities to help assess patients showing symptoms related to the ongoing COVID-19 pandemic. The first of these was installed at Maimonides Medical Center
, the largest hospital in Brooklyn, New York, which is the U.S. epicenter of the virus.
United Imaging expects uMR OMEGA to be especially useful in sports medicine for broad patients and off-center examinations that make up the bulk of orthopedic applications.
Clearance for uMR OMEGA was made in March and announced this month. The first model of UMR OMEGA will be installed in the summer of 2020 in United Imaging’s Houston showroom facility.