The news today said BeaMed was on track to submit for FDA approval via 501(k) track in Q2 2024. So what is the 501(k) track?
From the internet I got this definition of 501(k):
510k approval is a process to get marketing clearance for a Class II Medical Device1. The process requires finding an equivalent product (predicate device) to prove its substantial equivalence1234. Once the device is proven equivalent to an already approved equivalent, it can be legally marketed as per US FDA guidelines1245. The FDA processes 510k submissions in 30-90 days2. The purpose of a 510k submission is to provide the FDA approval with documented evidence which proves that the medical device is substantially equivalent to a predicate device2. The 510k clearance process got its name from Section 510 (k) of the Federal Food, Drug, and Cosmetic Act4. Critics of the fast-track program have found loopholes in the process, such as the fact that predicate devices from which new products are being anchored have not been carefully assessed for their safety and effectiveness since they were legally marketed even before 19764.
Two things to take away from this is that (1) the approval process usually takes 30-90 days and (2) it must prove equivalent to an already approved equivalent. I find this screwy at best for most new devices are improvements of already approved devices. The current systems cannot do what the Scorpion can do so how can they judge the safety of our device compared to an older device that doctor's wouldn't even let be used on the critical patients that will require the Scorpion?
I have to admit that I have a fear that AI is going to be able to come up with something quite like the Scorpion in no time at all if they have any access to how our device works in regards to the software and the systems allowing the interaction of the laser/MRI device/etc
