Southoz,They applied in Sept 2012, and it went the full 120 days...

Southoz,

They applied in Sept 2012, and it went the full 120 days before discussions were cut off as required by congress. Ultimately in March, the FDA determined that sonosentry and the old whezeometer weren't substantially equivalent, which was disappointing given they use the same algorithm and functionally work the same way. So to answer your question, they do not have a marketable device in America.

FWIW, the FDA also determined that AsthmaSense would be a class 1 device and require a 510k submission. It's still pioneering medical app requirements so this wasn't as obvious as it may appear.

Comment from MT at the time:

1. Companies are subject to the whims of the reviewer, not necessarily the published guidance documents; consequently, companies often miss the first time what the FDA wants

2. The FDA, due to new pressure from Congress, cut off our discussions to limit the review process to 120 days. We were not allowed to follow up with more clinical data (which we have) to prove our point

I have absolutely no concern about regulatory risk for SonoSentry or AirSonea. It is not a matter of “if” but a question of “when.” The FDA is notoriously capricious (not just for us, but for large firms like Johnson & Johnson, Medtronic, etc…). This was an inconvenience, but not a “big issue.”