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Highlights

  • Nanosonics shares jump 13% to a 52-week high of AU$4.95.
  • FDA grants De Novo clearance for the company's new infection prevention system, CORIS.
  • Global expansion plans include regulatory approvals in the UK, Europe, and Australia by early FY 2026.

Shares of Australian infection prevention company Nanosonics Ltd (ASX:NAN) soared 13% on Thursday, reaching a 52-week high of AU$4.95. The surge comes after the company announced a major milestone: U.S. Food and Drug Administration (FDA) De Novo clearance for its CORIS system, a groundbreaking cleaning technology for flexible endoscopes.

Why FDA Approval is a Game-Changer

Nanosonics’ new CORIS system addresses a critical issue in medical device reprocessing—effectively cleaning flexible endoscopes, which are widely used in procedures like colonoscopies. These instruments are notoriously difficult to clean, particularly their internal channels, which can harbor dangerous biofilm buildup.

With FDA clearance, Nanosonics is now set to launch CORIS in the U.S., marking a major expansion beyond its flagship trophon device, which revolutionised ultrasound probe disinfection and drove the company’s revenue growth over the past decade.

CEO Michael Kavanagh called the approval a “key milestone”, paving the way for commercial rollout and reinforcing Nanosonics’ position as a leader in infection prevention technology.

What’s Next for Nanosonics?

  • Controlled U.S. Market Launch – The company will first work with select hospitals for initial implementation before a broader commercial rollout in H2 FY 2026.
  • Global Expansion – Regulatory approvals are expected in the UK, Europe, and Australia by the first quarter of FY 2026.
  • Product Expansion – Over time, Nanosonics plans to extend CORIS to cover a wider range of flexible endoscopes beyond colonoscopes.