Updated Figures, page-48

FDA wouldn't be close so doubt there is any FOMO there. If they have sent an application in without informing the market, the FDA states the typical 501(k) takes around 90 days from the FDA confirming receipt of the application. I note many reviews take longer for various reasons and real word averages are closer to 150 days. Assuming IME has told us nothing, the earliest they've practically done it would be week 1 Dec, give a week to confirm then 90 days from there (best endeavours) So best case its a late March approval if nothing goes wrong and they are telling us nothing. Under the MDDS process for software it could be quicker but best I have found so far is that if its more basic software, it just is subject to less enerous compliance obligations. I note PME, VHT have 501(k) so doubt IME can do different. This is all before you factor in the government shutdown with the FDA running on C&M essentially.