Thanks maxcha for the link.
The below text is from the 4C announcement.
Over the last six months, Analytica Ltd has recruited an Australian sales team responsible for
the introduction of the PeriCoach system to physiotherapists and incontinence practitioners to
develop a professional support network. In conjunction with the establishment of a professional
support network the PeriCoach Team has built clinical advisory boards, obtained Therapeutic
Goods Administration (TGA) approval in Australia, submitted an application for approval to the
Food and Drug Administration (FDA) and displayed the product at multiple incontinence
conferences. The goal of these activities was to establish the PeriCoach system’s credentials as
a medical device.
So I expect the FDA decision to be received before the end of March 2015.
Cheers
