Virginia-based Rivanna has initiated a feasibility study evaluating its artificial intelligence (AI) enabled Accuro XV musculoskeletal imaging system.
The study will enrol 200 patients to assess the device’s safety and integration into the emergency department’s workflow. The trial will also gauge the Accuro XV system’s ability to render automated diagnostic ultrasound images.
The trial initiation follows $30.5m in funding from the US Biomedical Advanced Research and Development Authority (BARDA) from July 2023. The grant is expected to support Accuro XV system’s development and submission of an application for Food and Drug Administration (FDA) clearance.
The Accuro XV system uses ultrasound-based bone and 3D soft-tissue imaging technology with AI-enabled software to automate the detection and volumetric assessment of skeletal fractures and soft tissue injuries. The device is intended to be used in emergency departments to identify soft tissue injuries during the acute phase to ensure timely triage and treatment.
Rivanna’s CEO and co-founder, Dr Will Mauldin noted that “the true value of Accuro XV lies in its ability to assess both fractures and soft tissue injuries simultaneously, which is not achievable with X-ray imaging.”
"Since October 2021, we have quickly progressed from design to proof of concept in clinical sites, thanks to our collaboration with BARDA," said Delphine Le Roux, director of program management at Rivanna.
"Study data will expedite the development of Accuro XV for comprehensive point-of-care musculoskeletal diagnostics and validate product design with emergency department physician end-users."
The use of AI in the diagnostic imaging market is set to rapidly grow and is estimated to exceed $1.2bn by 2027, up from $336m in 2022 as per GlobalData analysis. GlobalData also expects the global revenue for AI platforms across healthcare to reach an estimated $18.8bn by 2027.
Rivanna’s contract with BARDA also has a funding option to develop another AI-enabled fracture detection system, CADe/x. The US agency can provide funding up to $56.4m to support CADe/x system’s development through a 510(k) clearance from the US FDA.
Multiple companies have developed AI-aided solutions geared towards diagnostics. Earlier this month, Perimeter completed enrolment for the pivotal trial of its AI-assisted imaging technology, the Perimeter B-Series OCT system, for performing breast-conserving surgeries. The device is intended to be used in breast cancer patients who are undergoing breast-conserving surgeries to mark the margins and not leave any cancerous tissue.
