Not exactly correct. For an FDA market approval a medical device must be proven to be safe AND effective. This can be proven in several ways: through a trial or

Not exactly correct. For an FDA market approval a medical device must be proven to be safe AND effective. This can be proven in several ways: through a trial or as I believe in this case, through similarity to another proven device. And this is not the only bar. If you have a new device you also have to get reimbursement from health insurance. This is not guaranteed just because you have FDA approval.