BARDA has partnered with RIVANNA to develop the Accuro XV toward U.S. market entry. BARDA will support the advanced research and development of the Accuro XV from a benchtop prototype to a fully functional, market ready fracture detection device with decision-assist technology to help advance emergency medicine.
The Accuro XV is a portable, computer-aided, 3D fracture detection and diagnosis system based on ultrasound imaging. The device is intended for rapid, radiation-free, bedside fracture triage. If development is successful, such a device may help reduce bottlenecks in routine care and mass casualty blast trauma incidents by quickly providing a detailed digital visualization of an injury site and determining whether a fracture is present. This approach may enable emergency departments to fast-track care for the large number of low severity, simple fractures and sprains.
In the wake of any chemical, biological, radiological, or nuclear (CBRN) incident, easily deployable triage tools are needed to help save lives and enable a rapid response. Blast-related trauma typically includes multi-system, life-threatening injuries that demand swift triage and treatments either in the field or in the emergency rooms. Overwhelming numbers of trauma patients are anticipated in the immediate aftermath of a CBRN incident, and it is vital to conserve X-ray resources for the highest priority patients. The Accuro XV helps make that possible by enabling rapid triage of fracture severity. A portable, radiation-free alternative for fracture screening may help reduce the need for limited X-rays resources – the equipment, as well as the physical space and specially trained personnel required for X-rays – in a mass casualty incident, such as a radiological or nuclear emergency.
Additionally, the Accuro XV’s cart-based device is designed to be portable, which would enable the device to be deployed in multiple environments. These features could help meet the CBRN Burn/Blast Program’s objectives of improving care by reducing bottlenecks and of addressing care of fractures and extremity injuries, which account for more than half of all injuries in mass casualty incidents. The advancement of field-deployable equipment aligns with BARDA’s commitment to developing medical countermeasures that are fast, accurate, and able to be used in a wide array of settings.
The Accuro XV aims to have sensitivity and specificity comparable to X-rays and potentially lower overall costs of care while also eliminating the use of radiation, when possible. The Accuro XV platform is also being designed with advanced features such as algorithms for artificial intelligence (AI) integration for automated detection of fracture and guidance. To help bring Accuro XV to market, BARDA will initially support RIVANNA’s prototype development, usability study, and understanding the market adoption landscape. In the future, additional investments will allow for achieving the U.S. Food and Drug Administration (FDA) 510(k) clearance via training and validation studies.
The following information is provided by the company and does not indicate endorsement by the federal government of the company or its products.
RIVANNA® is elevating global standards of care through the development and commercialization of imaging-based medical technologies, including BoneVision™ and BoneEnhance®, which optimize ultrasound image acquisition and visualization to provide radiation-free alternatives to X-ray-based imaging modalities. When paired with SpineNav3D™ AI-Enabled Image Recognition technology, these products offer comprehensive clinician-assistance solutions that improve decision-making, clinician workflows, health outcomes and patient satisfaction. RIVANNA is privately held and operates an FDA-registered and ISO 13485:2016 certified manufacturing facility where it produces the Accuro® product line and related medical equipment and components. For more information, visit rivannamedical.com.