Fair enough. You obviously have a lot more skin in this game than I do, I have just done a bit of quick Google Scholar research to see why the FDA might have made the decision that it did, and I'm less familiar with how much the trend vs. the point accuracy is important.

But what it comes down to is, there was something about the accuracy during the first 12 hours that gave the FDA cause for concern. Whether the FDA is overly cautious or not is an open question; I do know that in the US we get worse health outcomes for more money than most other developed countries. How much of that is due to our terrible system for paying for health care, which is privatized but with enough regulatory capture and inefficiency to drive prices way up, and how much of that is due to higher costs and lower access to medication and devices not being available due to excessively stringent regulations from the FDA would be something interesting to study.

I think that the FDA could probably loosen up its regulatory process just a little bit and provide a net benefit. Not sure with how much there is wrong with health policy in the US, and partisan politics around it, that's very likely, however. It would be interesting to see if there have been any studies done on this.