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Re: flybabyfly post# 65904

Wednesday, 01/31/2018 5:00:03 PM

Wednesday, January 31, 2018 5:00:03 PM

Post# of 140474
Per MD&A

Q1 2018
Complete software development, system design and update Design History File for regulatory filing applications

Q2 2018 Verify production system operation with clinical experts under rigorous formal (summative) human factors evaluation under simulated robotic manipulation exercises, and exercise completed surgeon simulation software and training program

Q3 2018 Complete and document preclinical live animal (swine) surgery studies that are representative of anticipated human surgeries for FDA submittal

Q4 2018
Prepare and submit 510(k) application to FDA and prepare technical file for CE Mark and submit to European Notified Body

- Publish white papers on preclinical studies containing evidence of system performance in live animal surgeries that are representative of anticipated human surgeries