Danish medtech company ROPCA has received U.S. Food and Drug Administration (FDA) 510(k) clearance for ARTHUR and DIANA, its technologies for automating elements of musculoskeletal ultrasound acquisition, analysis and reporting. The clearance allows the company to take the next step toward making the technologies available to healthcare providers across the United States.
ARTHUR has been CE-marked since 2022 and has several years of clinical experience across six European countries, with more than 5,400 scans and 83,500 joints scanned to date, according to ROPCA. Until now, the company’s presence in the United States has focused on research and clinical validation.
Automated Musculoskeletal Ultrasound Workflow
ARTHUR performs standardized musculoskeletal ultrasound scans, while DIANA analyzes the resulting images and supports automated report generation, according to ROPCA. Together, the technologies combine image acquisition with AI-assisted analysis and reporting, while clinical decisions remain with healthcare professionals.
ARTHUR is designed to automatically capture ultrasound images of finger, hand and wrist joints under healthcare-professional supervision. FDA documentation describes the system as an accessory to FDA-cleared ultrasound machines. It is intended for adult patients under clinical investigation for, or monitoring of, musculoskeletal diseases and is operated or supervised by trained healthcare professionals in healthcare facilities.
“FDA 510(k) clearance for ARTHUR & DIANA is a defining moment for ROPCA. ARTHUR, our Arthritis Ultrasound Robot, is designed to automatically capture ultrasound images of finger, hand, and wrist joints under healthcare-professional supervision – opening a new model for scalable musculoskeletal diagnostics. For providers, it can help address capacity and consistency; for patients, it points toward faster access to specialist assessment. We are now ready to build the U.S. clinical and commercial partnerships that take this new category forward,” explained Johannes Schaeferhoff, CEO of ROPCA.
U.S. Rheumatology Capacity
The clearance comes amid capacity challenges in U.S. rheumatology. According to figures cited by ROPCA from the American College of Rheumatology, 72% of U.S. counties do not have a single rheumatologist. Workforce projections cited by the company indicate that demand for adult rheumatologists could reach 8,184 clinical FTEs by 2030, compared with a projected supply of 3,455, representing a projected shortfall of 4,729.
Matthew J. Koster, MD, Associate Professor of Medicine in the Division of Rheumatology at Mayo Clinic in Rochester, Minnesota, said ARTHUR has been used at Mayo Clinic in a research setting. In ROPCA’s announcement, he said technologies such as ARTHUR have the potential to expand access to objective imaging and increase clinical capacity as demand for rheumatologic care grows.
Moving Toward U.S. Availability
The FDA lists ARTHUR under 510(k) K260190 and DIANA under K260192, with both receiving substantially equivalent decisions. With the clearances, ROPCA can move toward making its automated ultrasound acquisition and AI-assisted analysis technologies available to healthcare providers in the United States.
Source: ROPCA
