Medtronic plc Granted Breakthrough Device Clearance for PCL Insulin Pump

Medtronic has announced that it received Breakthrough Device clearance from the FDA for its Personalized Closed Loop (PCL) insulin pump system, which is still currently in development.

According to Medtronic, the system will automate insulin delivery in real-time and be personalized to the user. The system will provide insights and predictive diagnostics unique to the individual, with the ultimate goal of simplifying diabetes management.

"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," said Alejandro Galindo, president of the Advanced Insulin Management division within the Diabetes Group at Medtronic. "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."

The FDA Breakthrough Device Program was designed to help speed patients’ accessibility to cutting edge technologies that may offer more effective treatment or diagnoses for life-threatening and debilitating diseases or conditions.

According to a press release, the FDA will provide Medtronic with priority review and interactive communication regarding development and clinical trial protocols for the device, all the way through commercialization decisions.