Nanosonics Wins First FDA 510(k) Clearance to Expand CORIS Endoscope Use

Nanosonics Limited ( (AU:NAN) ) has issued an update.

Nanosonics has secured its first U.S. FDA 510(k) clearance expanding the range of endoscopes that can be reprocessed using its CORIS disinfection system, building on an earlier De Novo clearance for the initial indication. The company is already preparing a second 510(k) submission to further broaden CORIS coverage, positioning the platform as a more comprehensive solution for endoscope reprocessing.

Controlled Market Release of CORIS is underway in the UK, with additional sites to be added in Australia and across the UK and Ireland, and U.S. CMR to follow once early deployment insights are gathered. Nanosonics plans a phased full commercial launch from FY27 in each region after completion of local CMR programs, a timetable that underscores its long-term commercial strategy and potential to strengthen its position in the infection prevention market.

The most recent analyst rating on (AU:NAN) stock is a Buy with a A$5.55 price target. To see the full list of analyst forecasts on Nanosonics Limited stock, see the AU:NAN Stock Forecast page.

More about Nanosonics Limited

Nanosonics Limited is an Australian medical technology company specialising in infection prevention solutions for healthcare settings. Its portfolio includes the CORIS system, designed for high-level disinfection of endoscopes, with a focus on improving patient safety and workflow efficiency across key markets including the U.S., UK, Europe and Australia.

YTD Price Performance: -13.35%

Average Trading Volume: 540,264

Technical Sentiment Signal: Sell

Current Market Cap: A$1.04B

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