CT Company's Bedside Portable MRI Seen as Medical Care Breakthrough in Yale-New Haven Study

A study just-published in the Journal of the American Medical Association (JAMA) Neurology demonstrates for the first time the feasibility of a Guilford company’s industry-changing portable low-field magnetic resonance image (MRI) device at the bedside, rather than a conventional imaging suite, in critical care settings.

Researchers tested the feasibility and demonstrated the clinical utility of the Hyperfine Research Inc.’s Swoop™ Portable MRI System to obtain bedside neuroimaging for critically-ill patients in the intensive care unit.  The new portable system was utilized with 50 patients, including COVID-19 patients, to assess brain injury and detect abnormalities.  These patients were critically ill and presented challenges for transport to conventional MRI suites in the Radiology Department.

Results from the prospective, observational single-center study, “Assessment of Brain Injury Using Portable, Low Field Magnetic Resonance Imaging at the Bedside of Critically Ill Patients,” were published on September 8, 2020, highlighting the impact of the device developed by the Connecticut-based company.

Investigators used the Swoop™ system from October 2019 through May 2020 at Yale New Haven Hospital and successfully detected abnormal neuroimaging findings at the bedside of patients presenting with ischemic stroke, hemorrhagic stroke, subarachnoid hemorrhage, traumatic brain injury, brain tumor and COVID-19 patients with altered mental status.

According to the study’s senior author, Kevin N. Sheth, MD (Yale University School of Medicine, Department of Neurology), the use of traditional MRI units presents accessibility and transportation challenges in the care of critically-ill patients. Furthermore, the highly contagious nature of COVID-19 patients makes bedside MR imaging compelling for infection control protocols.

The study concludes that “These findings demonstrate for the first time (to our knowledge) the deployment of a portable MRI to the bedside of patients with critical illness. In acute neurological settings, it is well established that noninvasive, time-sensitive neuroimaging is the cornerstone of triage and treatment pathways. For ICUs, access to MRI is limited, and the risks of transporting patients with critical illness are well documented.”

The authors add that “This experience demonstrates that low-field, portable MRI can be deployed successfully into intensive care settings.  This approach may hold promise for portable assessment of neurological injury in other scenarios, including the emergency department, mobile stroke units, and resource-limited environments.”

Amidst a challenging year in health care due to the coronavirus, the breakthrough technology developed by Hyperfine has increasingly resonated well beyond Connecticut.

Earlier this year, Hyperfine Research, Inc. announced that it had received US Food & Drug Administration 510(k) clearance for the world’s first bedside Magnetic Resonance Imaging (MRI) system. The system is highly portable and wheels directly to the patient’s bedside, plugs into a standard electrical wall outlet, and is controlled via a wireless tablet such as an Apple iPad®.

The Hyperfine system is 20X lower cost, 35X lower power consumption, and 10X lower weight than today’s fixed conventional MRI systems, according to the company. It was designed to address the limitations of current MRI systems in order to make MRI accessible anytime, anywhere, to any patient.

Swoop™ is the brainchild of Hyperfine, a company founded in 2014 by longtime scientist-inventor Dr. Jonathan Rothberg.

“Nearly six years ago, a dream to create a portable, affordable MRI system was born. We assembled an astounding team, and they took the 10 million-fold improvement in computing power since MRI was invented and the best of the billions invested in green electronics and built something astonishing, something disruptive,” Rothberg said.

The Hyperfine point-of-care device represents multiple innovations in MRI design, architecture and workflow; the Swoop™ Portable MR imaging device uses a magnetic field, radio waves and a computer to produce detailed pictures of the body's internal structures that are clearer, more detailed and more likely in some instances to identify and accurately characterize disease than other imaging methods.

“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,” said Dr. Khan Siddiqui, Hyperfine’s Chief Medical Officer. “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 Guilford company has pointed out that the complete Hyperfine system costs less than the annual service contract alone for most current MRI systems, and it consumes 35 times less power than those same systems. Designed as a complementary system to traditional MRIs, new users can be trained on system operation, device navigation and device safety in about 30 minutes, officials note, helping clinicians to streamline workflow.  Rothberg told New Haven Biz earlier this year that the company plans to widely market the device, and looks for it to particularly make a difference in parts of the world where access to an MRI has been limited, thus improving medical care. 

The JAMA-published study noted “This single-center series of patients with critical illness in an intensive care setting demonstrated the feasibility of low-field, portable MRI. These findings demonstrate the potential role of portable MRI to obtain neuroimaging in complex clinical care settings.”  The study has had more than 16,000 online views in its first week of publication.

Hyperfine is part of 4Catalyzer, a health technology incubator with facilities in Connecticut, New York, California, and Taiwan. The mission of 4Catalyzer is to make healthcare more accessible and maximize societal impact.