Medtronic, yesterday, announced it has received Breakthrough Device Designation from the US FDA for its Personalised Closed Loop (PCL) insulin pump system – currently in development.
The PCL technology is designed to automate insulin delivery in a way that is real-time, personalised and adapts to the user; very much similar to AAPS. The system will also provide insights and predictive diagnostics unique to the individual, with a goal of dramatically simplifying diabetes management.
The FDA Breakthrough Devices Program helps patients receive quicker access to new technologies. Under this program, the FDA will provide Medtronic with priority review and communication regarding device development and clinical trials; thus speeding up the time to get new devices to market.
The statement does not specify which devices will use the PLC system but based Medtronic roadmap and the given descriptions it is most likely going to be the 780G and/or 890G. The development of these, alongside the FDA breakthrough, should get these devices to market significantly quicker.
Click the link for the full press release: FDA PLC Press Release