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FDA approves United Imaging’ uMR OMEGA MRI for bariatric patients

Thu, 06/11/2020 - 08:33
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United Imaging has received FDA clearance of the uMR OMEGA magnetic resonance imaging (MRI) scanner, the world’s first ultra-wide 75-cm bore. With the widest bore in the market at any field strength, uMR OMEGA provides a unique, patient-centric experience designed to accommodate a wide range of patients. With a 75-cm bore and 680lbs table capacity, uMR OMEGA addresses evolving demographics in the US community, not only improving patient comfort for all but creating, for the first time, an MRI for bariatric patients.

“The uMR OMEGA is a significant breakthrough. With this new scanner, United Imaging addresses the needs of healthcare providers to comfortably accommodate more patients in their community, including much of the 40 percent of the US population suffering from obesity and the 2.5 percent of the population suffering from claustrophobia” said Dr Jeffrey Bundy, Chief Executive Officer at UIH Solutions. “The uMR OMEGA represents a critical advance for patients who will now have access to an enhanced patient experience and a more accommodating MRI scanning environment. “I’ve seen first-hand over the past decades how meaningful comfort is to patients in a bore, and it was important to us that we innovated in a way that removes barriers to care for more people.”

The scanner adeptly serves paediatric and geriatric patients with faster scanning for both children and seniors who cannot stay still for long periods of time. Healthcare providers can offer new services, such as acute imaging in the emergency room with an ultra-fast 5 minute stroke protocol and cardiac imaging with a single breath-hold that significantly reduces the number of required scans.

“Healthcare facilities, as a requirement, must be able to accommodate patients in terms of the spaces they occupy. That includes the imaging of bariatric patients, first in terms of the patient space in the gantry and second in terms of the capacity of the patient table, both of which are limiting factors for MRI,” explained said Abram Voorhees, vice president of MR. “Other imaging modalities (CT and X-Ray, for example) have certain classes of machines that can serve the bariatric population, but MRI historically has not. In addition to not meeting these physical attributes well, MRI machines are challenged with producing diagnostic images for patients of all sizes with high quality (high signal, low nose) and without artifacts, which is more and more difficult the larger the patient. Historically, quality has decreased with patient size, ultimately to the point where some patients may be ineligible to receive this important diagnostic exam. There is also a comfort issue, and the wider the size of the bore the more comfortable larger patients may be inside of it.”

According to Voorhees, the current limitations for bariatric patients provided a key motivation for the uMR OMEGA, to help expand access to scans for patients that are underserved due to body habitus. Subsequently, United Imaging built the OMEGA to overcome these issues by introducing an ultra-wide 75-cm bore and 680-lb. high capacity patient table in a three Tesla (3T) magnet. In addition, the magnet homogeneity and gradient power, both of which are the basis of image quality in MRI , were designed to produce a larger, high-quality, 60 by 60 by 50 cm imaging volume for patients, to set a new benchmark for bariatric imaging. In addition, the uMR OMEGA expands the MRI space to decrease anxiety and increase patient comfort.

The company has received “very positive” feedback for the uMR OMEGA because of the promising end result, which is the ability to accommodate a part of the patient population that is underserved with MRI today. A three Tesla (3T) magnet that sets a new benchmark in homogeneity has been welcomed because of the larger imaging field-of-view and diagnostic quality of the images in the body, both of which are difficult to achieve with large patients. The company has also had the feedback that a device like uMR OMEGA that can accommodate a larger range of patients will have a big impact serving communities and offers healthcare providers more versatility, which can be especially important as they consider investments in new capital equipment.

“At United Imaging, we are all driven by patient experience: focusing on it, understanding it, improving it,” said Abram Voorhees, vice president of MR. “We intimately understand the anxiety that individuals can experience while undergoing an MRI, as well as the physical limitations of MRI machines today that can make a potentially life-saving study inaccessible. uMR OMEGA was created to remove the obstacles that often limit access for patients. Today’s important announcement brings to light a critical need for our communities and healthcare overall.”

The US is the first country in the world to receive uMR OMEGA. It received its FDA clearance in March 2020 and will be installed in United Imaging’s Houston showroom facility in the summer of 2020.

“United Imaging’s plans from the beginning were to launch this product in the US. The company has made substantial investments in this country for years and launching uMR OMEGA here first is another. The scanner because of its capacity and image quality can benefit many different kinds of patient populations, and it’s the first of its kind, so we will introduce it to other markets globally over time,” Voorhees added.