FDA

“The FDA has actually shared that it's the first technology that they have encountered that takes in vocal frequencies or signals.”

“We received a non-significant risk designation from the FDA, and we wanted to actually put the technology forward To the general population, because the technology, the more data is actually processing, the better it actually becomes. So, we submitted the data…”

“In Europe and Canada, but not in the U.S. They haven't tried to sell their device in the U.S. Yet, and so that leaves this, not only this enormous market opportunity in the U.S. For us, but it also just like rolls out the red carpet in terms of getting FDA cle…”

“So they have like three to five year exclusivity if we were to get approval and things of that nature.”

“They haven't done any tests at all. It was like a pretty much a free for all pre-two 1016 where anybody could release a product and they were grandfathered in.”

“I assume a hardware company takes seven to ten million dollars to get the thing done.”

“We've done a bunch of FDA things. Always takes longer. Always costs more money.”

“We're now raising four million, which helps us reach our first 10,000 patients and get the strep product through FDA from a screening tool to a diagnostic.”

“The intention is to go through clinical trials, which we're planning for in Q four of 25, go through FDA and get approved as a diagnostic.”