FDA grants Breakthrough Designation for Medtronic’s insulin pump system

Medtronic plc has announced that the FDA has granted Breakthrough Device designation for its Personalized Closed Loop insulin pump system, currently in development, which is designed to automate insulin delivery in a real-time, personalized way and provide insights and predictive diagnostics unique to the individual to make patient diabetes management so much easier. The FDA will provide Medtronic with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions.
Dr. Kevin Kaiserman, pediatric endocrinologist, SoCal Diabetes, said: “It is incredibly rewarding as an endocrinologist to see this novel closed loop innovation in development as it holds significant promise for simplifying diabetes management and taking on much more of the work on behalf of the patient. I’m pleased to see the FDA continuing to support the acceleration of important therapeutic options that address true unmet needs and commend them for these efforts.”
Alejandro Galindo, president of the Advanced Insulin Management division within the Diabetes Group at Medtronic, said: “We are very excited to receive the Breakthrough Device designation from the FDA as it will help us deliver this broadly anticipated innovation to patients much sooner than expected. We believe the Personalized Closed Loop system will be transformational for diabetes management, and the personalized nature of the algorithm clears the path to a true closed loop system. We have a long history of partnership with the FDA and look forward to another successful collaboration with the Agency to bring this important innovation to patients.”