>for the condition it targeted, an incorrect diagnosis would kill. But that's not always the case, it's not even the average case. Where there is much lower ri

>for the condition it targeted, an incorrect diagnosis would kill. But that's not always the case, it's not even the average case. Where there is much lower risk, there should be much lower barrier to entry. Treating every medical device as if it were a likely Therac-25 is not even remotely a good solution, and in some of these cases the lack of approved medical equipment is directly contributing to many peoples' untimely deaths, and to even more peoples' poor-health and/or poor quality of life.