After a long delay, the U.S. Food and Drug Administration has approved Medtronic's MiniMed 780G device, the company's next-generation insulin pump.
Medtronic's diabetes division has been under a regulatory cloud since the FDA inspected the company's Northridge, Calif., facility and issued a warning letter in December 2021 about how the company handled complaints, assessed product risks and dealt with some of its insulin pump recalls.
Medtronic, which has its operational headquarters in Fridley, recalled its MiniMed 600 series with an updated retainer ring to prevent damage in 2019 and recalled the optional remote control used with its MiniMed 508 and Paradigm pumps in 2018 because of a potential cybersecurity risk.
All that slowed the approval process for the 780G.
"I'm absolutely thrilled to expand this breakthrough technology to individuals with type 1 diabetes in the U.S., as it addresses meal management: a significant burden that's consistently cited as the most challenging for diabetes management," said Medtronic Diabetes president Que Dallara, who joined the company just three months after the FDA warning, in a statement.
The 780G is currently approved for use in 105 countries and has been available in Europe since June 2020.
Medtronic described the MiniMed 780G as the "only system with meal-detection technology that provides automatic adjustments and corrections to sugar levels every five minutes."
A clinical study showed 780G users stayed within the recommended blood sugar levels — between about 70 and 180 mg/dL — 75% of the time, 5% better than the American Diabetes Association's guidance.
The FDA approved the MiniMed 780G for users with type 1 diabetes who are at least 7 years old. Medtronic will start taking U.S. preorders for the device on May 15 and expects to start shipping them later in the summer.
Janet Cho, senior director of global communications for the company's diabetes operating unit, said Medtronic has not yet received any communication from the FDA about the status of the past warning letter, but that does not create any delays for producing and selling the 780G.
The FDA has recently re-inspected Medtronic's California facility, home to the diabetes business, to confirm the company has addressed the issues raised in the warning letter.
Medtronic CEO Geoff Martha has referenced the warning letter issue during every quarterly conference call after reporting the company's financial results, as analysts have closely monitored it out of concern it has negatively affected the company's sales.