Intuity Medical said today that it won 510(k) clearance from the FDA for its Pogo 1-step glucose meter.
Sunnyvale, Calif.-based Intuity said the device is designed to combine the lancing, blood collection and analysis functions involved in measuring blood glucose into a single step.
“Pogo’s unique and patented technology has the potential to change the lives of millions of patients who see glucose testing as burdensome. More than half of the 287 patients in our pivotal clinical study reported that they would better adhere to their healthcare professional’s recommended testing schedule using Pogo as compared to their current meter,” president & CEO Emory Anderson said in prepared remarks. “With this FDA clearance milestone, the Intuity team will be focused on raising capital and building the company’s infrastructure for Pogo’s commercial launch.”
“Pogo brings new and unique features to home glucose monitoring,” added Dr. Steve Edelman of the University of San Diego and founding director of Taking Control of Your Diabetes. “By reducing the number of steps and supplies needed to test, Pogo addresses some of the common barriers to testing and gives patients a new way to test their glucose. As clinicians, making testing more convenient for the patient is essential to their diabetes care.”
Intuity, which raised a $76 million Series D round in 2011, added $5.5 million in 2014.
