EPAT General Discussion, page-937

I was at the AGM. PD mentioned they had begun the FDA process, to ask about submission requirements, confirm the Class 1 device, and whether they needed to do additional testing in US. Maybe the recent peer reviewed study will cover it, maybe not. I think they will submit for FDA clearance in Q1 in 2018 and it will be granted in Q2, although they have reached all milestones ahead of schedule so far. Their announcement of TGA clearance came out of the blue without fanfare, so it may also happen for FDA clearance.