They have not lodged it I don't think it really matters...

They have not lodged it
I don't think it really matters regarding the FDA.
Miller had this fetish regarding medical devices and shifted the company there not understanding the market
The tech is readily applicable to the consumer market and that is where the major value is. Therecis value in medical devices but its a small market in comparison.
And I dare say that is where the issue with RealTek may stem, RealTek does not care less about medical devices, they want to sell their chips to whoever wants to buy them whereas Miller if you watched the webinars openly lampooned any suggestions that NUH sell and license the tech into the consumer market. He expressed open disdain for the suggestion.
We will find out soon, but it would not surprise me that is where the sticking point was for the commercial agreement with RealTek.