Nanosonics Limited (ASX: NAN) has hit a major milestone, securing FDA De Novo clearance for CORIS®, its innovative new system designed to enhance infection prevention in hospitals. This approval marks a significant step forward in the company’s mission to improve medical device reprocessing, particularly for flexible endoscopes, which are notorious for biofilm buildup and infection risk.
Why CORIS® Matters
CORIS® is a game-changer for endoscope cleaning, offering an automated, high-precision cleaning process to ensure superior hygiene standards. Unlike traditional methods, which often struggle with the complex internal channels of endoscopes, CORIS® delivers a more effective and consistent clean, reducing contamination risks and improving patient safety.
Nanosonics CEO & President, Michael Kavanagh, emphasized the importance of this clearance:
“CORIS represents a significant opportunity for the organisation, and FDA De Novo clearance is a major milestone in bringing this much-needed innovation to market.”
Next Steps: Global Expansion & Market Rollout
With FDA clearance secured, Nanosonics is now preparing for international approvals in the UK, Europe, and Australia, expected by Q1 FY26. Additionally, the company is preparing a 510(k) submission to the FDA to expand CORIS® indications beyond colonoscopes to cover all major categories of flexible endoscopes.
The first phase of commercialisation will begin in Q1 FY26, with a controlled market release in select hospitals to gather real-world insights before a full-scale launch. A broader market introduction is expected in H2 FY26, based on initial feedback and performance.
Looking Ahead
With its proven track record in infection prevention, Nanosonics is set to make a significant impact on the global healthcare industry. The FDA De Novo clearance for CORIS® reinforces its position as a leader in medical device reprocessing, and the upcoming launch marks the beginning of an exciting new chapter.
