Kem this is a rare biomechanical breakthrough since the pacemaker. You're a professional chemist and I believe a very astute one so I know you know a 2 to 3 year projection for first use off the existing certified national transplant list is completely unrealistic and gives false hope to past age specific or poor prognosis survivable candidates. Like the pacemaker this is cutting edge industry wide changing technology that for all intents and purposes singlehandedly just put the existing Hemodialysis industry on it's head. Like any Federal agency the FDA is not one to push cutting edge never before existing and tested medical technology before exhaustive research, analysis and animal testing has shaken out every possible issue contrary to favorable long and long term patient survivability vs, existing hemodialysis and the Chinese CHN Herbal Regimen. I predict a minimum 3 year test regimen before animal test trials if even then. I have more to say but work calls so we'll talk later my friend. Good read though, very informative.
My post seemed to have suffered a kind of "Back to the Future" thingy. I checked and they have a patent for it but I cannot get any more information about clinical trials, beta testing or anything relating to that. I hope you're right but knowing the FDA if the tribute is high enough, new treatment regimens and devices will get their rubber stamp of approval in short order especially when private investors are involved.
I can't find anything concerning application , approval or denial of application on the FDA website but if what they say in the news bit they could be on track with a tentative availability date.
https://www.fda.gov/
There are a couple of artificial kidney patents but I don't know if this is them.
https://www.uspto.gov/
www.google.com/patents/US5092886