They do not even have a final production unit to use for FDAtesting! They are still working on it!
From the MD& A shareholder meeting:
Product Development and Regulatory Approval The i/Blue Imaging System has entered the pre-production phase. The design and development phase of the i/Blue Imaging System has been completed and resulted in a final device configuration that surpasses the required performance verification testing and confirms that the required design inputs are fulfilled. The pre-production phase includes numerous engineering, manufacturing, and quality related objectives focused upon final preparations for pilot manufacturing runs. These include design freeze, complete design history and device master record documentation, procurement of production tooling for component parts, establishing documented manufacturing procedures and additional verification testing. Once the pre-production phase is completed, the pilot build phase will begin. The validation testing data obtained from the i/Blue devices manufactured during the pilot build will be submitted for FDA approval.