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Next-gen Medtronic insulin pump reportedly set for FDA submission, patch pump on the way

June 23, 2025 By Sean Whooley

Que Dallara Medtronic Diabetes
Que Dallara will be the CEO of MiniMed [Image courtesy of Medtronic]
BTIG analysts said today that MiniMed, the Medtronic (NYSE:MDT) diabetes business, has some significant pipeline updates.

Marie Thibault, Sam Eiber and Alexandra Pang shared notes from their meeting with Que Dallara, soon-to-be CEO of the to-be separated Diabetes unit, at the American Diabetes Association’s 85th Scientific Sessions in Chicago.

Among those updates, the company expects to submit a new automated insulin delivery system, the MiniMed Flex (8 series) pump, to the FDA by the end of the fiscal year. (Medtronic’s fiscal year ends in April, meaning the submission could come by spring 2026.)

It also continues to prepare for a label expansion to type 2 diabetes for the currently available MiniMed 780G. Finally, analysts say they received a look at the company’s in-development MiniMed Fit patch pump.

The company also already submitted an integrated pump for use with Abbott CGM as part of the partnership struck last year. Management emphasized the multi-year nature of the partnership, meaning Medtronic could pair its pumps with other Abbott sensors in the future. That could hint at integration with the company’s future dual glucose-ketone monitor, as a number of pump makers have already announced collaborations to pair their systems with the sensor once it hits the market.

On the MiniMed Flex, the analysts say it features a 300-unit insulin capacity and seven-day wear. It has a smaller footprint than existing pumps, the company said. The new system has compatibility with the Medtronic Simplera Sync CGM as well as the specially developed Abbott CGM at launch. Additionally, the analysts say it has an improved algorithm and backwards compatibility with existing supplies.

More on the Medtronic patch pump

Finally, analysts say they received a look at the company’s in-development MiniMed Fit patch pump.

With the MiniMed Fit, it also has a 300-unit insulin capacity and seven-day wear. Developed internally at Medtronic, it has both a rechargeable battery and a disposable component. The analysts say the battery should last longer than seven days per charge, and users receive two batteries.

Medtronic/MiniMed told the analysts that the plan is to pursue a dual-channel strategy, targeting pharmacy and durable medical equipment.

“Management believes that awareness in the PCP channel of MiniMed technology is already quite good and they expect it to be a promising opportunity moving forward,” the analysts wrote. “Separately, MiniMed is developing a new algorithm beyond the SmartGuard Advance algorithm.”

MiniMed Fit could rival leader Insulet and potential competitors Beta Bionics and Tandem Diabetes Care, who are developing their own. PharmaSens and SiBionics also recently unveiled their own entry, an all-in-one device.

Medronic was 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.

The company said earlier this year that it continued working on the patch pump development, and ADA signaled another potential step forward through the unveiling of the system.

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring, Technology Tagged With: ADA 2025, Medtronic, minimed

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  • Medtronic Diabetes names CFO with consumer experience ahead of separation
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  • GlucoModicum has positive data for needle-free CGM

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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