As a result of its meeting, Nemaura’s management has determined a clear direction for the clinical program and has appointed Navigant (NYSE: NCI) to develop the Investigational Device Exemption (IDE) application to submit to the FDA for approval, prior to commencement of the clinical program.
Nemaura Medical anticipates completing the clinical program and submitting the PMA application around mid 2017.
SugarBEAT® differs from existing CGM’s because it’s comprised of an adhesive daily disposable skin-patch which does not require insertion of a needle-like sensor inside the skin.
SugarBEAT® also provides users with tremendous flexibility as to when and how often they choose to wear the patch. Both of these factors are expected to empower users in a way current CGM’s cannot.
Nemaura Medical is developing the sugarBEAT System as a minimally-invasive, needle-free, wireless, continuous glucose monitoring system for use as an adjunct device for blood glucose monitoring.
Further opportunity may exist for use of the device in intensive care hospital settings, where continuous glucose monitoring is critical.