Projects like this suggest to me there is a combination of collusion and bs from the FDA driving up the cost of medical equipment in this country, as well as blocking innovation.
Having worked in the pharma industry, I can attest that there is no shortage of extreme risk aversion at the FDA. That being said, we just had an article here where someone claimed to have created a spreadsheet in pure javascript for some absurdly low number of lines of code. When you read through that thread there are all sorts of people pointing out that this isn't a real spreadsheet by any stretch. It merely looks like one, but is missing some pretty complex and necessary stuff. I would submit that what you see here is the medical device equivalent. There are no safety mechanisms, the system doesn't monitor itself for failure, there's no characterization of the limits of the system in various conditions, etc... That's fine because it's a hobbyist setup. But let's not kid ourselves about what it takes to have a reliable device that works in a hospital setting under a multitude of environmental conditions.
Things didn't end up the way they are by accident. The current situation is the result of decades of medical devices and interventions killing people because of faulty design. It's not unlike the situation with the FAA and airlines.