Still it says: Cyrcadia, Inc. expects to apply for FDA Clearance and a CE Mark, (to market in the European Union and Asian markets), with anticipation of launching its technology to market possibly in late 2017 or early 2018.
I read this as they need this and CE for Asia and Europe: in the sheet "global launch sequence 2018" at Asia/Europe they state this:
CE/FDA Regulatory Process
- Defined Time line to allow launch in FDA regulated countries H12018, CE countries H2 2018
At North America:
FDA Regulatory Clearance
- Cyrcadia Predicate 510K Class II exists now
- Sales can begin in US and other FDA guided countries H2 2017