I don’t know the timing of the update but also before anyone...

I don’t know the timing of the update but also before anyone assumes it’s all doom an gloom FDA sometimes indicate approval subject to some documentation updates.

in EYE recent FDA 510 device approval FDA requested sone documentation updates which were ‘administrative in nature’

if you check their early March investor preso it states this and says they expect FDA clearance in ‘coming weeks’. Then in early April they got approval confirmed

so FDA have recent 510 form in telling you to reformat the docs before you get the final tick even if they happy with the content