RE: FDA approval I believe the FDA approval process is still on going. In the Dec 21 NR about passing the ISO certification the following quote was made:
"Upon receipt of our ISO Certificate we will complete the required Health Canada and FDA filings, and the CE Mark Registration for the European Union and proceed to make PreVu commercially available to health care professionals and patients in North America and overseas in the very near term.”
On Jan 30 we announced EU approval and then on Feb 1 received Health Canada approval. Nothing was listed for final FDA approval but I think it is safe to assume if the European Union and Canada's health agencies gave the green light for commercial sale that the FDA isn't far behind.
All the best.
Stockington