FDA gives fast-track approval for Medtronic’s MiniMed 670G
"The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases – especially those that require day-to-day maintenance and ongoing attention," FDA’s Center for Devices and Radiological Health Director Jeffrey Shuren said. "This first-of-its-kind technology can provide people with Type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin."
The FDA worked interactively with Medtronic from the earliest stages of development to assist in making this technology available to people with Type 1 diabetes as quickly as possible," FDA Center for Devices and Radiological Health Director of Office of In Vitro Diagnostics and Radiological Health Alberto Gutierrez said. "We encourage companies to work closely with the agency to ensure scientifically sound, highly efficient clinical study designs, helping to expedite the FDA's evaluation and subsequent approval."