Answer: No, not yet. However, we do believe the process of getting FDA approval may be abbreviated. Here's why.
The Airing device does not provide a new treatment. The Continuous Positive Airway Pressure (CPAP) treatment has been around and used with FDA approval for years. The Airing device merely miniaturizes existing machinery into a portable and comfortable format.
We hope, although we obviously cannot guarantee, that the FDA would agree that the device is a constructive modification of an already approved treatment and be willing to approve its use on a timely basis.
Therefore we plan to explore the possibility of an abbreviated approval process know as 510(k) clearance, which would allow us to accelerate approval (months versus years). If this is not feasible, we would pursue the standard Pre-Market Approval route.
We will get there one way or the other.