I'm afraid I don't see it as a good thing. I see the competition doing what we are afraid to tackle head on. For example, we spent time and money on a surgeon training platform. What's the point of a trg platform if we haven't even attained design freeze? They got approval without a training platform in place. We shudder at the sound of de Novo, as we were led to believe time and cost projections would be astronomical, when as noted it is a pathway for low to moderate risk devices = "much easier approval process" as you point out. We should have had our single port system by now. Clinical trials not till end of next year? FDA in 2023? What is the delay?
aimho