Regulatory · Aug 26, 2026

ROPCA receives FDA 510(k) clearance for ARTHUR and DIANA

ROPCA received U.S. FDA 510(k) clearance for its ARTHUR ultrasound robot and DIANA image-analysis software.

ROPCA company media
Company media · ROPCA
  • ARTHUR performs standardized musculoskeletal ultrasound scans while DIANA analyzes the images and supports automated report generation.
  • By August 2026, ARTHUR had completed more than 5,400 scans and 83,500 joint scans across six European countries.
  • The clearance enables ROPCA to begin bringing the combined workflow to specialist clinical teams in the United States.

ROPCA develops autonomous ultrasound and AI analysis systems for musculoskeletal care. Its ARTHUR robot performs standardized hand and wrist scans, while DIANA analyzes the images and prepares reports for specialist review. Both systems received FDA 510(k) clearance in August 2026 after clinical deployments across Europe.