Thanks TechGoose.
A bit more research for anyone that has been wondering what the odds of FDA approval for Resapp are:
"The U.S. Food and Drug Administration (FDA) approved 98 percent of premarket approval (PMA) applications in 2015, the highest rate in the last 15 years" - https://www.meddeviceonline.com/doc/fda-s-pma-approval-rate-soars-to-year-high-0001
Given the app is non-intrusive, the strong results from trials so far, and the top-tier consultants and hospitals they are working with in the U.S., it would seem foolish to suggest that even conservatively the odds of FDA approval sit below 90% - that's a bet i'd take any day!!
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