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Frankestin

07/16/20 3:45 PM

#110427 RE: Frankestin #110425

I think they are ready for ask to FDA approval for IDE.

66Mustang

07/16/20 3:51 PM

#110428 RE: Frankestin #110425

They had software, and they have software. But now they probably also need to be able to integrate their software with the Digital Surgery package. I'm sure the co-development project with Medtronic will also be compatible with it right out of the gate; there was no need for us to be compatible last year but... things change!

Should be fairly easy overall... format data to be compatible with their database field formats, proper message headers, field sizes, etc. Database and communications interface code, maybe bluetooth or WiFi support to reduce cabling requirements, which suck more in an OR where if cables hit a bloody floor... Well, everything needs thorough decontamination between every case any way.

The GLP (Good Laboratory Practices) studies help ensure validity and quality of the subsequent trials and the data generated therefrom.


Message in reply to:
how did they start GPL studies without software?