Nanosonics Ltd (ASX: NAN) shares are jumping on Thursday morning.
At the time of writing, the ASX stock is up 13% to a 52-week high of $4.95.
Why is this ASX stock jumping today?
As well as getting a boost from a rebounding share market, investors have been buying this infection prevention company's shares this morning after it announced a major milestone.
According to the release, the ASX stock has received De Novo clearance from the U.S. Food and Drug Administration (FDA) for its latest innovation, the CORIS system.
This approval marks a significant step forward for the company as it prepares to bring its groundbreaking technology to market.
What is the CORIS system?
CORIS is an advanced cleaning system designed to tackle one of the biggest challenges in medical device reprocessing—effectively cleaning flexible endoscopes.
These vital medical instruments are widely used in procedures like colonoscopies but are notoriously difficult to clean, particularly in their internal channels, which can harbour dangerous biofilm buildup.
Nanosonics has developed CORIS to automate and improve this process, reducing infection risk and enhancing patient safety. The FDA's De Novo clearance confirms that the technology meets strict regulatory standards and fills an important gap in infection control.
Why this is a big deal for Nanosonics
FDA approvals can be a big deal for ASX healthcare stocks.
Nanosonics has already proven its ability to revolutionise infection prevention with its trophon device, which has become the global standard for disinfecting ultrasound probes. This has underpinned significant revenue over the past decade.
Now, with CORIS, the company is looking to replicate that success in the flexible endoscope market. CEO Michael Kavanagh called the FDA clearance a "key milestone" and a crucial step toward launching the product commercially. He said:
CORIS represents a significant opportunity for the organisation and the FDA de novo clearance marks a key milestone for the Company and an important step in bringing this much needed innovation to market.
The CORIS system has been designed to automate and provide superior cleaning outcomes for the channels of all categories of flexible endoscopes. 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.
What happens next?
The initial rollout will focus on a controlled market release, working with select hospitals to refine implementation before a broader commercial launch in the second half of FY 2026. Over time, Nanosonics also plans to expand CORIS's applications to cover a wider range of flexible endoscopes beyond colonoscopes.
It is worth noting that the ASX stock isn't stopping with the U.S. market. It expects to receive regulatory approvals for CORIS in the UK, Europe, and Australia by the first quarter of FY 2026.
