At the World GN conference recently it was exciting to learn that the company is going to pursue FDA approval for the Helo LX. This will be ground breaking for the company, and is even more proof of the visionary status of its leaders.
So what does it mean for a device to be FDA approved?
Basically the device must pass a rigorous review both of a scientific nature and of a regulatory one. The device must be effective, safe, and unique to the medical world. It also needs to be shown how the device will help a significant amount of the population. Even after a device is approved, it is subject to continued monitoring by the FDA.
The leaders at World GN know that this is going to be a huge accomplishment that can be enjoyed by the entire company! Interested in getting involved now while “the iron is hot?” www.ronhelo.me