Below is a post by Bollingenuity, it is possible they already have this clearance as not all companies deem every positive tick as announcement material!
128 posts.
Date:
12/01/17
Time:
10:43:15
Post #: 21841496
It is always a good sign when a coy replies to emails promptly. Here is the reply after I emailed yesterday requesting clarification of the 510k FDA clearance status:
We do have existing clearances including FDA 510(k) notifications for Smartinhaler products. The presentation recently released refers to a new generation smartinhaler developed for our partner AstraZeneca which is completing the 510k process in preparation for US launch in 2017. Regards
Sarah Donovan Executive Assistant to Chief Executive Officer Adherium
