SiNtx Technologies Inc (SINT)

[SmokerX]

Our goal in focusing on older predicates is to drive sponsors to continually offer patients devices with the latest improvements and advances.

help make sure that newer devices reflect more modern technology and standards that can improve patient care and outcomes.

developing proposals to potentially sunset certain older predicates

Rather than looking to the past as a baseline for safety and effectiveness – and rely on predicate devices that are sometimes decades old as our point of comparison – our premarket review would be based on a contemporary baseline that looks to the future and a baseline that can be updated as technologies advance. Sometimes, by relying on old predicates, it can actually make it more difficult for more advanced technology to reach patients since it’s harder for an innovative product to bridge to an outdated technology reflected in a decades-old predicate.

and ensure new products can more easily reflect beneficial new advances.

We’re planning to rename this new approach the “Safety and Performance Based Pathway”

Manufacturers would be able to demonstrate that their products meet or exceed objective safety and performance criteria that are based on modern technological principles. And companies could also, for the purposes of supporting coverage decisions, more readily demonstrate to payors that their products perform better than other devices on the market.

post-market surveillance systems

What is going through this guys mind? Why does that other tweet string look like a direct response to the other issue raised in bleeding edge? I`m about to quote the entire article at this point. This guy looks to be shouting something from a roof top in my opinion.