From the September 2024 Quarter Update:
"Australia, New Zealand, and Additional Regulatory Geographies.
Beyond the USA, we are using our FDA clearance as a springboard to expand into Australia and New
Zealand. We are on track to submit applications to the TGA and Medsafe in Q2 FY25.
Our next objective is to secure CE and UKCA marks for Europe and the UK. Obtaining these approvals
will pave the way for market entry across Asia and EMEA, as global demand for the Pulse continues
to grow."
https://wcsecure.weblink.com.au/pdf/CDX/02875553.pdf
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