Medeon Biodesign Secures US FDA Approval for Urocross; Sets Sights on $1 Billion Licensing Deal

In a transformative milestone for Taiwan’s high-end medical device sector, Medeon Biodesign announced on March 13 that its Urocross Expander System has officially received US FDA 510(k) clearance. This approval marks Amethyst’s transition from the clinical and regulatory phase to full-scale global commercialization.