Nanosonics (ASX:NAN) announced that the US Food and Drug Administration has granted 510(k) clearance for the first round of expanded endoscope indications for its innovative CORIS system.
The milestone marks a leap forward in the company's mission to revolutionise medical device reprocessing and reduce hospital-acquired infections.
Building upon the initial De Novo clearance previously granted for CORIS, this new 510(k) authorisation validates the system as "substantially equivalent" to legally marketed products while broadening its clinical utility.
The clearance immediately increases the variety of flexible endoscopes that can be processed using the automated system, which is specifically designed to tackle the difficult-to-clean internal channels where dangerous biofilms often persist.
"This first FDA 510(k) clearance keeps us tracking to plan as we execute against our key milestones," said Nanosonics CEO and President Michael Kavanagh.
He noted that the approval builds vital momentum for upcoming commercial activities, with a full global rollout scheduled for FY27.
Currently, a controlled market release is underway in the UK, with additional sites in Australia, Ireland, and the United States expected to follow shortly.
At the time of reporting, Nanosonics' share price was $3.69.