Walter Reed National Military Medical Center

CHICAGO--( BUSINESS WIRE )--GE HealthCare (Nasdaq: GEHC) has received FDA 510(k) clearance for its innovative SIGNA™ MAGNUS, i a 3.0T high-performance, head-only magnetic resonance imaging (MRI) scanner. This system offers new capabilities for both clinical imaging and neuroscience with the potential to aid in the detection of neurological, oncological, and psychiatric conditions. The FDA clearance of SIGNA MAGNUS underscores the advances made by GE HealthCare in neuroimaging. It features an innovative asymmetrical, high-efficiency, head-only gradient coil design, which achieves higher gradient performance due to its reduced inner diameter, specifically tailored for neuroimaging. The asymmetrical design shifts the gradient isocenter to the patient edge of the coil rather than its geometric center, enabling patient head access and avoiding shoulder width constraints. This head-only design allows MAGNUS to deliver a gradient amplitude and slew rate far surpassing those of conventional 60cm or 70cm bore whole-body MRI systems, marking a significant advancement in MRI technology for neuroimaging applications. "Obtaining FDA clearance further validates our commitment to not only innovating but also in delivering clinical technologies that have real-world impact," said Jason Polzin, GM, MR Applications Platform and Research Technologies, GE HealthCare. "With SIGNA MAGNUS, we are providing neuroradiologists and neuroscience researchers a tool that supports advanced imaging and biomarker research and discovery previously impossible on conventional systems. It is our intent to make SIGNA MAGNUS widely available as a fully cleared commercial product." A New Standard for Neuroimaging and Biomarker Discovery SIGNA MAGNUS offers exceptional precision, enabling high-resolution, high signal-to-noise ratio imaging, advanced diffusion techniques, and short scan times. To date, four investigational MAGNUS systems have been installed at Walter Reed National Military Medical Center, University of Iowa, University of Wisconsin – Madison and Brigham and Women’s Hospital. Dr. Vince A. Magnotta, PhD, Director of the MR Research Facility and Professor of Radiology – Division of Neuroradiology, University of Iowa, praised the FDA clearance, stating, "FDA clearance is important because there’s a broad need for new biomarkers to study neurodegenerative disorders, and there’s an opportunity to better understand what’s happening in psychiatric disorders." GE HealthCare has demonstrated leadership in high-performance gradient technology with the introduction of HyperG gradients, one of the most efficient gradient coils on the market ii , in the SIGNA MAGNUS system. The innovative asymmetric head-only design of the HyperG gradient coil invokes significantly less Peripheral Nerve Stimulation (PNS) thus maximizing the actual use of the system’s gradient performance for both clinical and research scanning. The HyperG gradient technology achieves remarkable performance levels of 300 mT/m and 750 T/m/s, enabling faster image acquisition while using the same power requirement as the whole-body SIGNA Premier 3.0T system. Shorter scan times mean less time spent in the MRI machine, which is particularly beneficial for patients who may have difficulty remaining still or those with claustrophobia. Improved gradient strengths lead to enhanced spatial resolution and image clarity. This can result in accurate diagnoses, allowing healthcare providers to detect subtle abnormalities and provide better treatment options. Clinical and Research Excellence The enhanced capabilities of the SIGNA MAGNUS system provide ultra-high anatomical resolution with shorter scan times. Its ability to visualize brain function, microstructure, and micro-vasculature through innovations such as ODEN (Oscillating Gradient Diffusion Encoding) which uses oscillating gradients to provide cellularity contrast which can be important for neurological oncology. Our intention is to leverage the high-gradient performance of SIGNA MAGNUS capabilities to allow for advanced research scanning such as high B-value diffusion imaging, fMRI for investigating the BOLD (Blood Oxygen Level Dependent) response and measurement of slow CSF (Cerebral Spinal Fluid) flow. This marks a transformative step forward in advancing neuroscience research. “We're very excited about the capabilities SIGNA MAGNUS provides,” said Kawin Setsompop, PhD, Associate Professor of Radiology and by courtesy Electrical Engineering, Associate Chair of Research Strategic Development, Stanford University. “I plan to leverage the gradient performance to look at microstructures with diffusion imaging, such as axonal diameter. Additionally, using the high slew rate for efficient readout in terms of EPI and spiral to sample k-space faster will help achieve higher resolution with fewer artifacts.” SIGNA MAGNUS will be available for both forward production and upgrades from compatible SIGNA Premier systems. This means that existing facilities can upgrade to this advanced technology, expanding access to high-performance imaging without the need for entirely new systems, additional power or cooling. This FDA clearance empowers the clinical community to adopt SIGNA MAGNUS into routine practice and further advances research in critical areas such as neurodegenerative, neuro-oncology and psychiatric disorders. Learn more about SIGNA MAGNUS at the Radiological Society of North America (RSNA) Annual Meeting, December 1–4, 2024, in Chicago, or online at gehealthcare.com . About GE HealthCare Technologies Inc. GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Advanced Visualization Solutions, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring. We are a $19.6 billion business with approximately 51,000 colleagues working to create a world where healthcare has no limits. Follow us on LinkedIn , X , Facebook , Instagram , and Insights for the latest news, or visit our website https://www.gehealthcare.com for more information. i SIGNA™ MAGNUS is 510(k) cleared with the FDA. Not yet CE Marked. Not available for sale in all regions. ii GE HealthCare data on file

WASHINGTON, Sept. 9, 2024 /PRNewswire/ -- The Independence Fund will testify before the House Veterans Affairs Subcommittee on Health on September 11, to present its views on legislation impacting catastrophically disabled Veterans and their Caregivers. The subcommittee is examining several legislative items and will hear testimony from multiple organizations. Representatives from The Independence Fund, a national Veterans non-profit, will provide insight on legislation and speak about the organization's efforts in serving the nation's catastrophically wounded Veterans. "The Independence Fund is proud to advocate on behalf of Veterans," said Clark Pennington, Chief Operating Officer of The Independence Fund. "This organization works every day to ensure Veterans and their families get the care and resources they deserve. Advocacy is a crucial part of our mission as experts in Veterans issues. We will provide our expertise as advocates and witnesses with the hope we can support and improve our government's legislation." Representatives of The Independence fund will testify and provide expert testimony to suggest improvements on several items that will directly impact Veterans and their healthcare. The hearing begins at 01:00 AM in Room 360 of the Cannon House Office Building open to the public and can be watched via livestream. To cover the hearing, The Independence Fund's testimony, and request interview opportunities, please contact [email protected] . ABOUT THE INDEPENDENCE FUND: Founded in the halls of Walter Reed National Military Medical Center, The Independence Fund was born to care for our nation's most catastrophically wounded surviving service members from the Global War on Terror. With an expansion to caring for the warfighter's family and all generations of wounded, ill, and injured heroes. The Independence Fund stands in the gap to help combat Veterans, active military, and wartime Allies with unmet needs. By restoring independence to those who sacrificed their independence so that we can remain a nation of freedom, The Independence Fund deploys tangible programs to restore our Veterans' and families' physical, spiritual, and emotional health. Known for the hallmark all-terrain track wheelchair program, The Independence Fund has provided over 2,600 trackchairs to severely wounded American heroes. ABOUT THE INDEPENDENCE FUND ADVOCACY TEAM: For Veterans returning with the scars of war, the fight doesn't end upon their arrival home. Unfortunately, some of the biggest battles are with the very institutions that are supposed to be on their side, whether it be the Department of Defense, the Department of Veterans Affairs, or Congress, when they simply don't understand the challenges Veterans face or when they turn a deaf ear. The Independence Fund's Advocacy team assists where the needs are greatest, amplifying the voices of those who fought for us. Media Contact: TIF Communications [email protected] SOURCE The Independence Fund

Novel FDA-cleared imaging technology reveals anatomy that traditional ultrasound devices cannot; initial focus on trauma as well as neurosurgery and interventional radiology TUCSON, Ariz., Aug. 22, 2024 /PRNewswire/ -- MAUI Imaging, inventor of patented technology that sees anatomy other ultrasounds cannot, today emerged from stealth with the announcement of a $4 million U.S. Department of Defense (US Army Medical Research and Development Command) contract to support trauma medicine across four branches of the military seeking to enable faster diagnosis and interventional care in high volume (mass casualty) and/or resource limited environments. "With the U.S. military contract and our technology becoming more visible on a broader stage, we've decided it's time to come out of stealth and show what we have been working on," said MAUI Imaging CEO and co-founder David Specht. "The feedback we have received from physicians and technologists highlights the profound need for a new ultrasound-based technology that enables imaging of all types of tissues. That need is most pronounced in trauma medicine, which is a major focus of MAUI's collaborative development efforts. Going forward, MAUI will be able to supply the volumetric imaging data for AI tools that predominantly come from CT and MRI." MAUI will present a poster describing their breakthrough imaging technology and its potential use in trauma diagnosis and triage at the Military Health System Research Symposium taking place August 26-29, 2024 in Florida. MAUI's Chief Medical Officer, John Cheronis, MD PhD will present imaging data from the initial studies funded by the MRDC. Additional imaging of trauma pathology is being developed in partnership with Dr. Rosemary Kozar, MD PhD from the University of Maryland Shock Trauma Center and Dr. Matt Bradley, CAPT USN, Uniform Services University of the Health Sciences, a part of the Walter Reed National Military Medical Center, as part of the USAMRDC project. Department of Defense: The USAMRDC-enabled program is sponsored by the Office of the Assistant Secretary of Defense for Health Affairs through the Combat Casualty Care Research Program under Award No. HT9425-23-3-0002. It is being implemented at the University of Maryland Shock Trauma Center in Baltimore, which is one of the major trauma centers where the military trains trauma surgeons and other related health care providers. Additional collaborative efforts at other trauma centers affiliated with the military are also being planned and will be announced when implemented. The program is designed to demonstrate that MAUI can improve time to care in trauma patients, ultimately improving outcomes as patients receive lifesaving treatments faster and more effectively, particularly in austere environments such as in the field, naval vessels, and evacuation aircraft. MAUI enables an approach to providing diagnostic imaging usually reserved for CT and MRI, which are not available in these settings. The USAMRDC project is divided into three Phases. In Phase 0, initiated in September 2023 and completed in June 2024, MAUI documented the baseline imaging performance of the system for more than 60 discreet anatomic regions, including intracranial and spinal imaging, needed for whole body trauma evaluations. No other ultrasound system is capable of imaging all of these regions. Phase 1 of the USAMRDC project will be focused on developing the procedures and techniques for using MAUI to image these 60 anatomic regions in a standardized fashion. Phase 2 will be focused on comparative imaging of actual trauma pathology in the Emergency Department. A committee of independent expert physicians reported that MAUI can image comparably, or better than traditional ultrasound in areas where traditional ultrasound is used. In certain cases, like cranial and spinal imaging in adults, where traditional ultrasound has not been employed, MAUI has been reported to provide clinically meaningful images needed by physicians to diagnose, triage, and treat serious injuries. Traditional ultrasound cannot image intracranially without a significant "window" into the skull involving large fractures or surgically removed bone. As a result, patients require CT or MRI scans which are often unavailable. MAUI is designed to change this and aims to decrease time to diagnosis and treatment. "Trauma remains a major cause of death for individuals of all ages, both in civilian and military settings," said Rosemary Kozar MD, PhD, Professor of Surgery, Co-Director of Shock Trauma Anesthesia Research (STAR) Center, University of Maryland School of Medicine. "The ability to rapidly evaluate trauma without the need for immediate access to X-ray, CT and MRI facilities would be of tremendous value to trauma victims worldwide who have sustained significant injury. MAUI could be game changing in a mass casualty setting, underdeveloped countries and on the battlefield." "The MAUI ultrasound technology and the K3900 offer a potentially significant advance in the triage, diagnosis and management of trauma in austere environments, i.e., on the battlefield, on naval vessels, on evacuation aircraft, in field hospitals, and more," Eric Elster, MD, FACS, FRCSEng (Hon.), CAPT, MC, USN (Ret.). "This technology could provide for the rapid evaluation of injured war fighters and civilians in conflict zones by first responders (medics and corpsmen), nurses, technicians, and physicians with minimal training, thereby improving clinical outcomes in resource-restricted environments. We look forward to the results of this research funded by the US Army Medical Research and Development Command." MAUI's 510K FDA clearance: In October 2023, MAUI K3900 received its 510K FDA Clearance and is now available for commercial use. Because MAUI's technology differs from existing imaging ultrasound technologies, MAUI was required to conduct comparative image testing proving it can effectively image with a simple probe. No other recently cleared ultrasound systems have been required to do this, thus demonstrating the unique and powerful potential for this patented imaging technology. The MAUI K3900 Ultrasound Imaging System is intended for use by qualified healthcare personnel in environments where healthcare is provided for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); and Intraoperative (abdominal, thoracic and vascular). Examples of differentiating images for use in trauma, neurosurgery and interventional radiology can be found at mauiimaging.com/solutions. MAUI's Patented Computed Echo Tomography (CET): MAUI Imaging has created a novel and effective approach to medical imaging that provides views that look like a cross between ultrasound and CT without the need for dangerous ionizing radiation (x-rays). MAUI's CET pings the designated part of the human body, uniquely seeing anatomy beyond what other ultrasound systems can see. MAUI then uses proprietary patented algorithms to accommodate the reflected energy from various flight paths and sums up the data to create a reliable image of all the structures below the probe. Barriers such as bone, gas, fat, instruments, implants, etc. are intended to become part of the image instead of obstacles to image formation. MAUI is performing clinical studies with the military and elsewhere to fully demonstrate these capabilities. MAUI's core patents deal with solving for speed-of-sound issues in tissue, enabling views of a variety of tissue types, including lung and cranium, previously thought to be unobtainable. MAUI's portfolio is believed to be one of the strongest imaging patent portfolios with more than 160 granted patents and dozens more pending in and outside the U.S. MAUI uses a concave probe that fires pulses into the tissue from many different angles. The MAUI probe's concave shape sends and receives energy from multiple angles, one of the reasons allowing MAUI to see through and around barriers. This is something no other known ultrasound-based system can accomplish. MAUI's probe can also be much larger as it does not need to navigate between barriers, such as the ribs, making it more easily positioned over regions of interest. In addition to enabling clinicians to see beyond barriers without requiring more invasive imaging approaches, typically, a highly trained sonographer technician or physician is required to get images around the ribs and aim at what they want. With MAUI, the user doesn't have to worry about the ribs or perfect placement of the probe making medical imaging ubiquitous. The MAUI approach requires trillions of calculations per second which necessitated MAUI's requirement for Moore's law to catch-up to deliver a portable cost-effective solution. MAUI's approach also creates a significantly larger data set that can be sliced into an infinite number of images more like CT than traditional ultrasound. The dataset that MAUI produces can be used for deeper analytics, providing more insight about the anatomy it scans. Currently traditional ultrasound represents <10% of AI in medical imaging, MAUI's volumetric imaging should dramatically change this. About MAUI MAUI Imaging's Computed Echo Tomography (CET), uses ultrasound to insonify through and beyond barriers for rapid and effective imaging of the human body and is protected by more than 160 patents. MAUI's FDA Cleared system produces a large-scale dataset and novel insights that can assist in rapid and effective diagnosis and treatment. MAUI Imaging has multiple clinical sites and studies in process in trauma, pediatric neurosurgery, and interventional radiology departments. MAUI's CET system enables rapid imaging of the brain, and other internal organs and structures, in real time by existing clinical personnel without additional training. For more information visit mauiimaging.com. Media Contact: Chris Gale ([email protected]) SOURCE MAUI