Sure Thing or Longshot?
Considering the quoted text below, it seems that such a radical advance in technology would likely need a PMA (along with a clinical test,) rather than a 510k approval. Maybe the company felt it was worth taking a longshot chance at 510k to save a lot of money and time? If this 510k fails or takes much longer we will halve share price again. The fallback could be to find a partnering angel invester like Carl Icahn to make it happen?
"Any device that reaches market via a 510(k) notification must be "substantially equivalent" to a device on the market prior to May 28, 1976. If a device being submitted is significantly different, relative to a pre-1976 device, in terms of design, material, chemical composition, energy source, manufacturing process, or intended use, the device must go through a pre-market approval, or PMA.
A device that reaches market via the 510(k) process is not considered to be "approved" by the FDA. Nevertheless, it can be marketed and sold in the United States."
