Comment by bee_rider
10 hours ago
Yeah, it seems that their pitch is that they want to move at consumer electronics speed, I mean, their website explicitly says
“Our tech-driven approach leverages software, hardware and AI […]
That means we can iterate at the speed of consumer electronics”
Which is kind of scary but also a bit interesting.
How would you go about regulating an open source medical device? The user can just plop whatever software on there that they want, and ultrasound themselves wherever… play with resonance and focusing, right?
> How would you go about regulating an open source medical device? The user can just plop whatever software on there that they want, and ultrasound themselves wherever… play with resonance and focusing, right?
The manufacturer will still need to validate their own firmware and subsequent updates. Whether it’s open source or not doesn’t matter because a huge part of the approval process is quality control tied to a specific manufacturer.
Anyone who plops their own software will be liable for the consequences and I doubt malpractice insurance would allow it in the vast majority of cases.