> Beyond that, regulation is the next limit. Normally, for every diagnostic medical capability you need FDA approval. We’re starting by just giving you detailed body composition maps — and we’ll be submitting regular test results to the FDA for increased capabilities.
This is just not how the FDA works. At all. You can't just email them slideware and marketing materials to keep them in the loop.
You have to hire an army of expensive compliance people (cheap ones aren't nimble enough for startups), develop the whole thing start to finish under strict design controls, and usually throw a lot of time and capital into convincing regulators your very innovative and disruptive new R&D endeavor is actually derivative enough to draft behind some existing medical device.
For reference, OP is talking about the 510(k) process. One of the issues with that process is that an approved medical device may end up with a whole tree of "derivative" devices approved through the 510(k) process. If that original device is then found to have problems and has its approval removed, those derivative devices do not also become unapproved.
That may be true, but the FDA is no longer run by fiduciaries of the United States.
Just grease the right tanned palms, and you're good to go!
It sounds like they are trying to fly under the FDA thresholds for regulation as a medical device and be considered a low risk "wellness device" which makes no medical diagnostic claims and has low risk. This is why it is in spas and not doctor's offices.
https://www.fda.gov/regulatory-information/search-fda-guidan...
> FDA may consider certain products that use non-invasive sensing (e.g. optical sensing) to estimate, infer, or output physiologic parameters (e.g. blood pressure, oxygen saturation, blood glucose, heart rate variability) to be general wellness products when such outputs are intended solely for wellness uses, and provided they:
• are non-invasive and not-implanted;
• do not involve an intervention or technology that may pose a risk to the safety of users or other persons if specific regulatory controls are not applied;
• are not intended for the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition;
• are not intended to substitute for an FDA-authorized, cleared, or approved device;
• do not include claims, functionality, or outputs that prompt or guide specific clinical action or medical management; and
• do not include values that mimic those used clinically unless validated (e.g. manufacturer testing, peer-reviewed clinical literature) to reflect those values
do they need FDA approval to have a good impact? it doesn't need to be a licensed medical device for me to interpret the data, and then verbally tell my doctor what's wrong
this is similar to how people get a lot of medical value out of chatgpt today
You can't have any impact at all if you can't legally operate it or if you are hamstrung in your marketing claims.
Chatgpt is just words. This is an ultrasound imaging system. Who knows what could go wrong: blown out eardrums from feedback, acoustic burns, wild inaccuracies that lead to misdiagnosis.
There's really no way around documentation as a way of collecting evidence that the team knows what they are doing. Things like enumerating all the possible patient risks, assessing their severity, updating the design to mitigate, and ultimately testing that it works as intended.
This is why you can't just bolt on the medical device part. Most devs will have a conniption if suddenly expected to attend lots of meetings and do a lot of paperwork. Different skillset and very expensive to switch out your whole workforce.
Let's say you do a diagnostic based on the results of this machine. Later, patient suits and you have to answer for your diagnostic. If the only evidence for your diagnostic is coming from a non-FDA approved machine, you're liable.
It needs approval from someone to ensure it's safe first and foremost - health & safety inspections, hygiene, FCC approval, etc.
And FDA approval (I presume) if they want to give formal diagnoses, but I believe that if they don't get that it'll fall under the "alternative medicine" umbrella, which is very broad. But they can do whatever under that umbrella as long as it's safe.
I wonder how doctors feel about people consulting ChatGPT. I know a doctor who can't stand people getting medical advice from quacks on TikTok, but that's probably a different problem/pattern
Since they hated Google I'm sure they also hate chatgpt.
Mostly they hate patients who have opinions