Nanosonics Wins FDA De Novo Classification for CORIS® Medical Device

Nanosonics (ASX: NAN), a hospital infection prevention company, has secured a key regulatory milestone, with the FDA granting De Novo classification for its CORIS® system.

The FDA’s De Novo pathway is reserved for novel medical devices that lack a direct market precedent. Unlike the 510(k) pathway for medical devices, which allows for clearance by demonstrating similarity to an existing product, De Novo classification signals that CORIS® is a first-of-its-kind innovation in the U.S. market.

Nanosonics intends CORIS® to be the first of its kind to automate cleaning of the flexible endoscope.

The CORIS® system automates the cleaning and disinfection of flexible endoscopes, offering a standardized, repeatable process that reduces human error and enhances patient safety.

The company details that it uses advanced fluid dynamics and controlled cleaning cycles to decontaminate intricate endoscope channels, addressing a gap in infection control. This is thought to provide healthcare operators with a more reliable and efficient alternative to manual cleaning method currently employed.

Strategic Rollout and Market Impact

Nanosonics’ CEO Michael Kavanagh called the approval a major milestone, positioning the company for U.S. market entry. Initially cleared for colonoscope reprocessing, the company plans to expand indications across all major flexible endoscopes. Regulatory approvals in the UK, Europe, and Australia are also in progress, expected by Q1 FY26.

The commercial rollout remains on schedule, with early adoption efforts focusing on market awareness, targeted hospital trials, and a gradual scale-up before full market launch in H2 FY26. The company is preparing a 510(k) submission to extend indications, reinforcing its long-term market strategy.

Financial and Stock Performance

Nanosonics reported a profit before tax of $10.9 million for H1 FY25, with revenue reaching $93.6 million. Demand for consumables and service-related revenue streams grew by 20% year-on-year.

Recent public health crises have heightened the need for advanced infection control solutions, strengthening demand for automated sterilization technologies. With healthcare facilities under increasing regulatory pressure to enhance infection prevention, Nanosonics is well-positioned for growth.