Research, page-763

FDA approval for devices is very easy. 4DX has that. But FDA approval for claims of superiority over existing devices are really what is needed. These take time, money and research studies. Take a look at OSP for that story. Their tech has FDA device approval, but their hoped for FDA-approved claim on reducing mortality from their large funded study didn’t quite reach statistical significance, even though it did demonstrate some other good clinical benefits. Since not getting the FDA ‘mortality’ win OSP has been in a death spiral itself.
4DX has device and algorithm approval from FDA. That’s only the first step. Next they need to show (and prove) a clinical and/or cost benefit.
I’m not against 4DX. It has been routed no more than most other small biotech and tech companies that are still a long way from profit. Sentiment against these stocks is dreadful at the moment. I am hoping very overblown, because I hold quite a few of them!