Nanosonics wins second FDA 510(k) clearance for CORIS endoscope indications
Nanosonics (ASX: NAN) has received a second FDA 510(k) clearance from the United States Food and Drug Administration (FDA) for expanded endoscope indications for its CORIS System. The clearance expands the range of endoscopes that can be reprocessed using the device.
The expansion includes a number of high-volume colonoscopes and gastroscopes. Building on the De Novo clearance and the first 510(k) clearance, it advances the company’s roadmap to expand CORIS across a broader range of endoscope indications.
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What the CORIS System does
The CORIS System is an automated endoscope channel cleaner designed to improve the cleaning of flexible endoscope channels, a critical first step in the reprocessing of reusable endoscopes.
The regulatory steps named by the company so far are:
- De Novo clearance
- First 510(k) clearance
- Second 510(k) clearance (this announcement)
Michael Kavanagh, CEO & President of Nanosonics
“Securing our second FDA 510(k) clearance is another important milestone for the CORIS System and demonstrates continued execution against our regulatory and commercialisation strategy, and planned launch activities in the United States. We remain focused on progressively broadening the range of endoscopes that can be reprocessed with CORIS across all our key geographic markets…”
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