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Medtronic seeks to expand MiniMed 780G label to type 2 diabetes, submits new CGM to FDA

February 18, 2025 By Sean Whooley

Medtronic MiniMed 780G automated insulin delivery system with Simplera Sync CGM Sensor
The MiniMed 780G with the Simplera Sync CGM and accompanying devices. [Image courtesy of Medtronic]
Third-quarter results for Medtronic (NYSE:MDT) today included a timeline for a planned label expansion for its automated insulin delivery platform.

The medtech giant posted an overall revenue miss for the three months, despite growth in the Diabetes business. (Read more about the company’s third-quarter results at sibling site MassDevice.)

Speaking on the company’s earnings call today, CEO Geoff Martha outlined the business’ performance and looked ahead at what’s to come, including a potential label expansion for the MiniMed 780G automated insulin delivery system.

Martha and company officials reiterated their outlook from last month’s JP Morgan Healthcare Conference, where they looked ahead to next-generation technologies and new applications.

“We’re seeking expanded labeling for the 780G, including type 2 diabetes, which is a meaningful new opportunity,” Martha said. “We expect to file this with the FDA here in the first half of the calendar year.”

Expansion to the type 2 population was a theme for several diabetes tech makers at the American Diabetes Association Scientific Sessions last June. Insulet’s Omnipod 5 automated insulin delivery system became the first and only such system cleared for type 1 and type 2 diabetes last August.

Que Dallara, EVP and president of Medtronic Diabetes, said last month at JP Morgan that the company is “progressing very well” on type 2, including with a clinical study.

“There’s a lot in Diabetes to come,” Martha said today. “But, it’s already been growing double-digits here for a number of quarters.”

Medtronic Diabetes’ performance and what’s to come

Revenues of $694 million for the quarter saw Medtronic Diabetes grow 8.4% year-over-year (10.4% organic growth). The company attributed growth in the U.S. to continued MiniMed 780G adoption and an increase in the system’s installed base. It also noted strong continuous glucose monitor (CGM) attachment rates.

Additionally, Medtronic Diabetes saw international revenue grow on increasing CGM attachment as users upgrade to the Simplera Sync sensor. Simplera, the company’s next-generation CGM, also received FDA approval in August. The Medtronic Simplera platform includes the Simplera CGM for use with the InPen smart insulin pen and Simplera Sync for integration with the MiniMed 780G.

Martha said Medtronic submitted Simplera Sync for FDA approval. Meanwhile, the company continues integration work through its landmark collaboration with Abbott. The partnership aims to collaborate on a system based on Abbott’s FreeStyle Libre CGMs with Medtronic’s automated insulin delivery technology.

Meanwhile, Martha reiterated the company’s interest and ongoing work on a patch pump platform. The company looked set to enter the patch pump space in late 2023 with a $738 million acquisition of EOFlow. However, about six months after striking that deal, the company called it off, citing multiple breaches of their acquisition agreement.

“We’ve got a couple of shots on goal, there,” he said during the company’s second-quarter earnings call. “I don’t believe we’ve given any timing on that, other than that we’ve been investing heavily in diabetes across the entire [ecosystem].

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), MassDevice Earnings Roundup, Patient Monitoring, Regulatory/Compliance, Technology, Wall Street Beat Tagged With: Medtronic

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

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