Not had any luck at the permitting stage for any of the medtechs I have followed in the past. These guys seem pretty confident of the outcome - a green light - and the consequence - some big bopper yank outfits signing up for the as a service product. Why not, I suppose? Surely some of these start-ups must make it past the regulators and move into the commercial phases. So, 90 days hey, ... set our alarms for Monday, 5 August ...
Ann: US FDA Application Lodged, page-2
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