Months ago, I believed the The Genset with a chip controller was not that revolutionary, that the moving of determination out of the Surgeons hands and more into software, should be as little different as a Stethoscope versus a Fetal heart monitor (software driven) machine.
As medical science, at best, is an inaccurate approximation
and the fundamental process used is "try it out on somebody and see what happens", I'm starting to lean towards the idea
the FDA is breaking a new path here.
True, no one knows how most of the drugs work, on a sub molecular level and all the ramifications, only the results. Towit; I think the FDA is having a field day, going back and forth with the company. Asking for cutouts, mechanically and software wise. With requests for guidance on tech procedures and help for insight so they may have oversight on this next generation of RF tech.
Not to be frivolous, but I can just hear it now..
FDA addressing Frank D.
"What if a cow crosses the road on a moonlit night against a head wind with one bad leg,,, will this affect the RF application time, or the signal level, or on off sequence ??
Frank D, addressing Ctgi techs
"WEll, the hoop for the day is writting into the software
a cow sequence".
Ctgi techs
"HUH??"
Frank D
"Just write into the software, sector 9, line 142 the following..
C;\cow crosses road goto
C;\moonlit night goto
C;\headwind goto
C;\bad leg goto
C;\turnoff voltage"
As Frank D. was noted saying(via third party)" It will pass FDA, cannot say when, but it will pass.
I do believe all other co.s that send their software driven
RF Sealer app.s to the FDA in the future will be indebted to Ctgi, at least morally, and will owe Frank D. an annual Christmas card in gratitude, imo.
AI
