Ann: New Direction for US Market, page-4

de novo approval was always going to be a struggle with 1 small study that had a huge drop out rate.

I wonder if, given Carrick is a Chiropractor, if the device will be aimed at Chiropractic clinics as a way of getting it in front of patients. Something to watch for as it could be a problematic approach given you don't associate Chiropractic with Autism. Hopefully they limit the practitioners they allow to have use of the device and can then build some real-world and useful data on whether the thing actually works or not.