Friday, July 28, 2023
RIVANNA®, a company specializing in imaging-based medical solutions, recently announced receiving $30.5 million in funding over 39 months from an early execution of an option by the Biomedical Advanced Research and Development Authority (BARDA). BARDA is part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). This funding will be used to advance the development of the Accuro® XV, a comprehensive point-of-care musculoskeletal diagnostics system, and to seek FDA clearance for the product.
The successful early option one funding will expedite the product development and initial clinical evaluations of Accuro XV for FDA clearance. RIVANNA expressed gratitude for the continued support from their funding partners and emphasized the strong collaboration among stakeholders involved in the project.
In addition to the $30.5 million, the contract with BARDA includes options for additional funding of up to $56.4 million, aiming to support the development leading to 510(k) clearance for CADe/x artificial intelligence (AI)-enabled fracture detection. The recent funding follows a base contract of $11.6 million executed in 2021, focused on the proof-of-concept product development and market assessment of Accuro XV. The primary objective of the project is to develop an FDA-cleared and clinically proven product that facilitates the triage of low-acuity extremity injuries in emergency medicine, with a specific focus on mass-casualty blast trauma incidents.
Accuro XV combines ultrasound-based bone and 3D soft-tissue imaging technology with AI-enabled software, offering distinct advantages over traditional X-ray methods. The system enables rapid automated detection and precise volumetric assessment of skeletal fractures and soft tissue injuries without subjecting patients to harmful radiation or requiring extensive user training. By helping clinicians make informed decisions about the necessity of X-ray imaging, Accuro XV aims to reduce unnecessary radiography. Moreover, it addresses a current limitation in emergency departments by swiftly determining soft tissue injuries during the acute phase, enabling accurate treatment decisions and prompt discharge of patients who do not need further intervention.
One of the key strengths of Accuro XV is its simultaneous assessment of fractures and soft tissue injuries, a feature not achievable with X-ray imaging. By providing comprehensive point-of-care musculoskeletal diagnostics, especially in high-pressure situations, Accuro XV addresses a critical gap in emergency medical response, facilitating cost-effective expedited care delivery, enhancing patient satisfaction, and improving outcomes.
Source: prnewswire.com
