As the other comments have stated - this isn't about valuation. This is a medical company that can, and probably has already, endangered patients' lives through its failings.

There is a reason why certain industries are scrutinized so closely because of the effect they can have on people. Being in those industries, even as a startup, means you must follow the rules.

Or are you fine with your doctor using some "unauthorized" random equipment the next time you need critical tests or surgery?