Nanosonics climbs after US FDA approves endoscope cleaning system
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The news: Nanosonics shares surged after the medical equipment maker received approval from the US Food and Drug Administration (FDA) for its cleaning system for flexible endoscopes.
The numbers: Nanosonics shares were up 12.8% to $4.93 at 1:50pm AEDT, extending gains of more than 80% over the last 12 months.
The context: The company said that the first phase of commercialisation for its CORIS system remains on track for the first quarter of the 2026 fiscal year. Pending results of the first phase, it expects to begin broader market introduction in the second half of FY26.
Nanosonics is also progressing approvals for CORIS in the UK, Europe and Australia, which are expected to be in place during Q1 FY26.
What they said: "The CORIS system has been designed to automate and provide superior cleaning outcomes for the channels of all categories of flexible endoscopes," said Nanosonics CEO and president Michael Kavanagh.
"The initial submission to the FDA was associated with colonoscopes and the intent is to expand these indications to cover all major categories of flexible endoscopes over time," he said.
The source: ASX
