FDA actions advance MiniMed and Portal Diabetes insulin pump systems
The FDA cleared MiniMed Flex, a screen-free insulin pump controlled by smartphone, and granted breakthrough device designation to Portal Diabetes’ implantable Portal Pump system. Portal Diabetes also began a Phase I study of Portal Insulin, while MiniMed said Flex supports its latest algorithm, sensors and infusion sets.
The U.S. Food and Drug Administration has cleared MiniMed Flex, a smartphone-controlled insulin pump, and granted breakthrough device designation to Portal Diabetes’ implantable Portal Pump system. MiniMed said the newly cleared device is smaller than previous MiniMed insulin pumps, while Portal Diabetes said the designation is expected to support priority engagement with the FDA as it moves ahead with clinical trials and regulatory submissions.
MiniMed, the diabetes tech company that separated from Medtronic in early March, received FDA approval for the new smartphone-controlled insulin pump. The MiniMed Flex is approximately one-half the size of the 780G, and users control it with their smartphones. The next-generation, screen-free insulin pump also features the latest version of MiniMed’s SmartGuard algorithm, which automatically makes real-time insulin delivery adjustments as needed.
The MiniMed Flex was built to support the company’s new Simplera Synch sensors in addition to the Instinct sensors made in collaboration with Abbott. It also works with MiniMed’s full infusion set portfolio, including the Extended infusion set that can last up to seven days. MiniMed has also launched the MiniMed Forward Program, which helps customers upgrade from the MiniMed 780G insulin pump to MiniMed Flex for no added fee.
Portal Diabetes said its Portal Pump combines an implantable pump delivering insulin into the abdomen, continuous glucose monitoring technology, and concentrated insulin to create a fully automated insulin delivery system for people with type 1 diabetes. The breakthrough device designation also makes the Portal Pump eligible for the transitional coverage for emerging technologies pathway, which can accelerate Medicare coverage once approved as a breakthrough device.
Portal Diabetes also initiated a Phase I study of its temperature-stable insulin, referred to as Portal Insulin. Under an investigational new drug application, the initial two patients have been administered Portal Insulin through injection into the intraperitoneal space at a clinical centre in San Diego, California. Clinical trials of the full combination system are expected to commence around the fourth quarter of 2027.
The Portal Pump is not authorised for sale or investigational use in the United States at present. Portal Insulin remains an investigational new drug and is not commercially available in the country.