The U.S. Food & Drug Administration granted approval to a new smartphone-enabled, automatic insulin delivery system from Acton medical device manufacturer Insulet Corp.
“Omnipod 5 is a life-changing technology that we believe will revolutionize the market and the lives of people with diabetes,” said Shacey Petrovic, Insulet president and CEO, in a written statement. “We are incredibly proud of this simple-to-use, elegant system, designed to deliver unmatched freedom and to greatly simplify insulin management and improve glucose control for our users.”
The approval allows individuals aged six years and older with Type 1 diabetes to use the device, according to Friday’s announcement from Insulet.
The Omnipod 5 Automated Insulin Delivery System is the first tubeless automated insulin delivery system that integrates with California-based Dexcom’s G6 Continuous Glucose Monitoring system, allowing the device to automatically adjust insulin levels. It can be controlled through a smartphone app.
The device is sent data gathered by Dexcom’s monitoring system every five minutes, predicting what the glucose values will be an hour into the future.
Omnipod 5 will initially launch through the pharmacy system in a limited release, progressing to a broad release. Insulet didn’t specify a launch date.
