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Novel FDA-cleared imaging technology initially focuses on trauma as well as neurosurgery and interventional radiology.
August 22, 2024
By: Rachel Klemovitch
Assistant Editor
MAUI Imaging, inventor of patented technology that sees anatomy other ultrasounds cannot, has emerged from stealth with a $4 million U.S. Department of Defense (US Army Medical Research and Development Command or MRDC) 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. 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 (MHSRS) which will take place on 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. “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.” 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 MRDC project. “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.” In October 2023, MAUI K3900 received its 510K FDA Clearance and is now available for commercial use. MAUI was required to conduct comparative image testing proving it can effectively image with a simple probe because of how it differs from existing technologies. No other recently cleared ultrasound systems have been required to do this, thus demonstrating the unique and powerful potential of 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). MAUI’s Computed Echo Tomography (CET) 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. “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 warfighters 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.” The MRDC-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. The MRDC project is divided into three Phases. Phase 0, was initiated in September 2023 and completed in June 2024. Phase 1 of the MRDC 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.
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