Nanosonics receives critical clearance from the US FDA

The news: Infection prevention tech company Nanosonics has secured a 510(k) clearance from the US Food and Drug Administration for the first round of an expanded endoscope indications for its CORIS system.

The context: Following the initial De Novo clearance granted for CORIS, this first 510(k) clearance, a term used to indicate a device to be “substantially equivalent” to an already legally marketed product, broadens Nanosonics’ plan to expand CORIS across a wider range of endoscope indications.

The company plans to fully roll out CORIS in FY27. A controlled market release is already underway in the UK, with Australia expected to follow shortly.

What they said: “This First FDA 510(k) clearance keeps us tracking to plan as we execute against our key milestones. It immediately broadens the range of endoscopes that can be processed with CORIS, building momentum for our upcoming market activities,” Nanosonics CEO Michael Kavanagh said.