Titan Medical Inc (TMDIF)

[elMoose]

Exactly. Nothing iffy that FDA can contest should be implemented for the first FDA approval of an instrument.


The liquid can indeed get contaminated so such a feature should be fail proof before it is added on. They can do that with later updates and seek approvals.

I recall reading about a rejected embedded device where the sealed battery housing was not designed to be disinfected during manufacturing process because I guess FDA believed that the seal can break.