Danish Firm's Arthur Robot Gets FDA Clearance for Autonomous Scans

pswider · x · 2026-08-31

ROPCA, a Danish medtech company, has received FDA 510(k) clearance for Arthur, an AI-powered fully autonomous ultrasound robot, and its AI analysis software Diana. Arthur performs standardized scans of finger, hand, and wrist joints under professional supervision, while Diana analyzes images and supports automated reporting. Previously CE-marked in Europe with over 5,400 scans, this clearance marks the company's entry into the U.S. market.

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