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Sunday, May 03, 2020 10:35:00 AM
Let's say the FDA had not heard of E.I.S. (electrochemical impedance spectroscopy) as a biological testing option before KB submited his application, which induced a storm of conversation between the company and the FDA. What of E.I.S.?
It is widely used in blood glucose testing.
Turns out there are courses taught on the subject, and at least one mainstream book publisher has a textbook on it:
https://www.wiley.com/en-us/Electrochemical+Impedance+Spectroscopy%2C+2nd+Edition-p-9781118527399
Other recommendations include:
https://www.researchgate.net/post/Please_recommend_a_book_on_impedance
A Pennsylvania company specializes in E.I.S. instrumentation. https://www.gamry.com/application-notes/EIS/
Interestingly, KB identified Pennsylvania as the location where some testing might be done: "We also anticipate a request to direct us to conduct a donor study of a modest group of donors. We have already identified a group in Pennsylvania to make use of the Genviro! Swift Home kit. Additional testing required for this kit is anticipated to take less than a week." (4/23) At least I'm assuming "make use of" is somewhat equivalent to "conduct a donor study" - who knows . . . maybe he has solicited Gamry to help with final design and tweaking of the instrument????
It is a given that technology moves rather quickly and can sometimes move exponentially . . . and those not willing to accept it may end up like Einstein in his apology to Lemaitre. Things just can't work that way . . . until they do.
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