ResAppDx is the first on the market, there are no similar medical device predicate, hence there was a meeting with the FDA to confirm ResAppDx could be submit for De Novo. However, SleepCheck will be able to be submitted for 510K (similar to Drowzle) where the approval will be faster but SleepCheck can detect AHI<15 and specificity is 85% compared to 60%.....need to market this as well.
ResAppDx is the first on the market, there are no similar...
Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #
