• FDA grants De Novo clearance for Nanosonics' CORIS system
• CORIS designed to reduce infection risk and enhance patient safety
• Automated mechanism combines science and engineering for improved endoscope cleaning

Nanosonics Limited, a leader in infection prevention solutions, has announced that the U.S. Food and Drug Administration (FDA) has granted De Novo clearance for its innovative CORIS system. CORIS is a novel technology designed to reduce infection risk and enhance patient safety by delivering improved cleaning outcomes for flexible endoscopes, particularly the complex channels of endoscopes prone to biofilm build-up. Through an automated mechanism of action, CORIS combines cutting-edge science and engineering with practical usability to address a critical challenge in medical device reprocessing. The initial FDA submission was associated with colonoscopes, and the company plans to expand the indications to cover all major categories of flexible endoscopes over time. Nanosonics is continuing its preparations for the commercial launch of CORIS, including obtaining necessary approvals in the UK, Europe, and Australia, which are expected to be in place during the first quarter of fiscal year 2026 (Q1 FY26). The first phase of commercialization, focused on raising market awareness and conducting a targeted controlled market release, is on track for Q1 FY26, followed by a broader market introduction in the second half of fiscal 2026 (H2 FY26).

The company expects to commence broader market introduction of the CORIS system in the second half of fiscal 2026 (H2 FY26).