Nanosonics (ASX:NAN) secured its first 510(k) clearance from the US Food and Drug Administration (FDA) for the first round of expanded endoscope indications for its CORIS system, according to a Monday filing with the Australian bourse.
The clearance allows for the expansion of the system across a wider range of endoscope indications and the submission of a second 510(k) to further extend coverage, the filing said.
Controlled market release has begun in the UK, with Australia soon to follow, per the filing.