Algernon Pharmaceuticals Inc (AGNPF)

[hoyowasobo]

In contrast, the regulatory process for medical devices is much shorter and, generally, less stringent and costly. It has been estimated that the time from concept to market for medical devices is 3–7 years, although no concrete data could be identified in the literature regarding time or cost.

http://www.medscape.com/viewarticle/807243_2

This clinical trial will be conducted using the NA-NOSE, an advanced stage, nanotechnology-based breath analysis device from the Technion — Israel Institute of Technology (for more on NA-NOSE, see news release dated Jun 28, 2016).

the fda process for medical devices is much shorter and we have already passed a big chunk of those 3-7 years imo as the device is already developped and we are in the clinical trial phase! im not that familiar with the fda approval process for medical devices so if someone is familiar with it id be glad to get some information! when can we expect that bthcf sends an application to the fda?