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Re: None

Sunday, 10/10/2021 2:27:33 AM

Sunday, October 10, 2021 2:27:33 AM

Post# of 140474
Right now:
Perform additional software development and test system performance
Perform electrical safety testing for surgeon workstations and patient cart, including electromagnetic compatibility (EMC) and electromagnetic interference (EMI) tests at independent lab
Perform animal feasibility or GLP study


In the next future:
Complete initial build of Enos system IDE units
Complete system verification testing
Complete HFE summative testing
Update application for IDE as additional testing lab data is received and continue preparation for human confirmatory studies
Submit IDE application to FDA (More adverse scenario - what if it were different.... while continuing to evaluate its options for use of the 510 (k) submission pathway)


if i were a shorts i would wonder why McNally insists on MD&A with DeNovo when Vicarious goes with 510k submission
why use the more expensive route if I can finance 510K without problems?
MMMMmmmmmm