Nanosonics Surges 13% After FDA Approval for CORIS System

Thu 20 Mar 25, 02:21 AM | Team Kalkine

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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.

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