RIVANNA Launches Groundbreaking Study for Imaging Technology

RIVANNA Launches Groundbreaking Study for Imaging Technology

RIVANNA®, a leader in medical imaging solutions, has embarked on an exciting venture by launching a pioneering multi-site clinical study to assess the Accuro® XV musculoskeletal imaging system. This significant step is supported by $30.5 million in funding from the Biomedical Advanced Research and Development Authority (BARDA), reflecting the company’s commitment to revolutionize diagnostic practices in emergency medicine.

Every year, millions of patients visit emergency departments (EDs) due to suspected distal extremity trauma, with a staggering number receiving traditional X-ray imaging. Data indicates that X-rays are performed on approximately 90% to 99% of these patients. However, studies have shown that the actual incidence rates of fractures can vary significantly, with fractures in the lower leg occurring between 8% to 19% and even higher rates observed in the distal arm.

Amidst this backdrop, RIVANNA aims to reshape the diagnostic landscape with the Accuro XV, a bedside ultrasound-based device designed to quickly assess fractures and soft tissue injuries in a non-invasive manner. Patients utilizing this technology can expect not only speedy diagnoses but also a reduction in exposure to harmful radiation, addressing a critical concern in emergency care.

Goals and Objectives of the Study

The upcoming feasibility study plans to enroll 200 participants to capture fracture images using the Accuro XV. The main objectives are to analyze the safety of the device, evaluate its integration into existing ED workflows, and determine its efficacy in providing automated ultrasound diagnostic images.

Enhancing Patient Care with Technological Advancements

The Accuro XV combines innovative ultrasound technology with artificial intelligence, facilitating rapid automated detection and detailed volumetric assessment of both skeletal and soft tissue injuries. This capability aims to overcome existing limitations in emergency departments, such as accurately identifying soft tissue injuries during acute phases and ensuring that appropriate treatment decisions are made swiftly.

Delphine Le Roux, PhD, PMP, the Director of Program Management at RIVANNA, highlighted the importance of this initiative, stating, "Since October 2021, we have quickly progressed from design to proof of concept in clinical sites, thanks to our collaboration with BARDA. Study data will expedite the development of Accuro XV for comprehensive point-of-care musculoskeletal diagnostics and validate product design with ED physician end-users." This statement underscores RIVANNA's dedication to enhancing the quality of patient care through advanced technology.

UVA Health is collaborating with RIVANNA, playing a pivotal role in the study's launch and optimization stages. The collaboration is set to expand further, with participation from renowned institutions like The University of Texas Southwestern Medical Center, known for its significant patient traffic, including over 240,000 visits annually.

Transforming Emergency Medicine

Dr. Chris Thom, an Associate Professor of Emergency Medicine at the University of Virginia, commented, "We are working to transform technological opportunities into applications that may improve treatment for low-acuity patients and reduce wait times." This focus is critical in a healthcare landscape facing challenges related to patient overload and the need for rapid yet accurate diagnoses.

RIVANNA’s ambitious project is bolstered by federal funding, ensuring resources are allocated effectively to support the exploration of innovations that can enhance patient outcomes. The collaboration with BARDA confirms the importance of this study in a national context, reinforcing the role of cutting-edge technology in modern medical practices.

About RIVANNA

As a commercial-stage medical device innovator headquartered in Virginia, RIVANNA® is committed to pioneering imaging technologies that set new global standards of care. The company operates a fully equipped manufacturing facility which adheres to rigorous regulatory standards, exemplifying its commitment to quality and innovation.

In summary, the first multi-site study of the Accuro XV musculoskeletal imaging system not only represents a technological leap but also a strategic rethinking of patient diagnostics in emergency settings, thereby enhancing overall care efficiency and effectiveness.

Frequently Asked Questions

What is the Accuro XV musculoskeletal imaging system?

The Accuro XV is a revolutionary ultrasound-based device designed to quickly assess skeletal fractures and soft tissue injuries without exposing patients to harmful radiation.

How many participants are involved in the study?

The feasibility study will enroll 200 participants to evaluate the safety and functionality of the Accuro XV system.

What are the key benefits of using Accuro XV?

The device offers rapid diagnostic capabilities, reduces the need for X-ray exposure, and aims to improve patient outcomes by streamlining decision-making in emergency departments.

What partnerships support the development of Accuro XV?

RIVANNA is collaborating with UVA Health and The University of Texas Southwestern Medical Center, enhancing the culmination of expertise and resources for the study.

What is RIVANNA's mission?

RIVANNA's mission is to develop and commercialize innovative imaging-based medical technologies that improve global standards of care in healthcare.

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