Nemaura Medical completes two usability studies for SugarBEAT
Nemaura Medical announced that it has completed two summative human factors usability studies for SugarBEAT. The usability studies were conducted according to the FDA guidance on "Applying Human Factors and Engineering to Medical Devices", in preparation for submission of its medical device application to the FDA for SugarBEAT. The two studies consisted of 16 participants each, including both Type I and Type II diabetics. Participants in the first and second study ranged from ages 18-50 and 51-70, respectively. The studies were designed to ensure adequate information was captured for the diverse age groups expected to use SugarBEAT. The objective of the two studies was to confirm that the user interface aspects of SugarBEAT met the FDA guidelines for medical devices.