InSpark Technologies Announces FDA Progress in Bringing Vigilant Diabetes Management Software to the Marketplace Meeting supports clear path to commercialization
CHARLOTTESVILLE, Va., May 12, 2014 /PRNewswire/ -- InSpark Technologies, Inc. announced today the results of a recent meeting with the FDA regarding the development and regulatory strategy for Vigilant* diabetes management software. Vigilant is an iPhone-enabled software 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 with diabetes can take action to improve their glucose control.
The FDA cited no significant concerns with a comprehensive package of completed and planned future studies, performance assessments for Vigilant's three principal pattern recognition algorithms and validation plans for the software system. Furthermore, the FDA was aligned with InSpark's perspective on the level of patient risk associated with the software system.
"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," said Erik Otto, president and co-founder of InSpark. "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."
Diane Horwitz, PhD, RAC, regulatory affairs consultant to InSpark Technologies said, "This is a testament to the work InSpark has done to create a well-thought out development plan that addresses patient safety and the user's interaction with their pattern analysis algorithms. It will be exciting to see people benefiting from the actionable information provided by Vigilant soon."
About InSpark Technologies, Inc.
InSpark Technologies is developing tools that help people with diabetes transform the significant amount of blood glucose data captured on a daily basis into useful insight. InSpark's technology pushes actionable pattern-related information to patients and health care providers at the time the time they need it most (such as when a patient is testing) rather than requiring them to pull the information from detailed charts, graphs, and log books. InSpark's technology is derived from a broad of suite of pattern recognition intellectual property licensed from the University of Virginia Licensing and Ventures Group. More information can be found at www.insparktech.com.
Vigilant™ is an iPhone-enabled software device 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.
* Vigilant™ is an investigational use software device that is not currently available for sale in the United States.
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SOURCE InSpark Technologies