Not true at all ....in case if FDA relayed that they did not approve of the submission they would simply make necessary changes and complete another attempt Everything your tiny brain has thought of, actually educated people with IQ 1000x more have worked around 1000x the scenario. This has been extremely thought out by well credited doctors and mayo clinic to boot. ALSO being accepted as breakthrough device is a massive step in a guided FDA program. Consider this as close to a shoe in as possible. Nice try though