After meeting with regulatory officials from the U.S. Food and Drug Administration, Charlottesville, Va.-based InSpark Technologies Inc. announced that the FDA voiced no serious concerns with a comprehensive package of completed and planned future studies of the Vigilant diabetes management software.
In a press release posted on the company's website, Erik Otto, president and co-founder of InSpark said, “We are delighted that in this meeting we had a similar view on patient-related risks for our software, and we are encouraged by the FDA’s feedback on our comprehensive development plan. This feedback gives us confidence in being able to deliver the benefits of Vigilant’s advanced pattern recognition technology to patients and clinicians in a reasonable timeframe.”
With technology licensed from the University of Virginia Licensing and Ventures Group, InSpark's Vigilant software is an iPhone-enabled application that analyzes blood glucose data and provides feedback about daily patterns of hyperglycemia, hypoglycemia, glucose variability, and test frequency in real-time, as well as patterns indicative of increased risk of severe hypoglycemia in the next 24 hours. It is designed to provide concise messages prior to periods of risk so that users can take action to improve their glucose control.