Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

Rhea-AI Summary

Medtronic (NYSE: MDT) has submitted 510(k) applications to the FDA for clearance of an interoperable insulin pump system that would integrate with Abbott's advanced CGM platform. The submission includes the MiniMed™ 780G pump as an alternate controller enabled (ACE) insulin pump and the SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC).

This development follows last August's collaboration announcement between Medtronic and Abbott. Under the partnership, Abbott will provide Medtronic with CGM technology that will work exclusively with Medtronic's smart dosing devices and software for both automated insulin delivery and smart multiple daily injections systems. These integrated systems will be marketed solely by Medtronic.

Positive

• FDA clearance would expand MDT's product portfolio with integrated CGM solutions
• Exclusive distribution rights for the integrated system
• Strategic partnership with Abbott enhances competitive position in diabetes care

Negative

• FDA approval remains uncertain
• Timeline for potential clearance not specified
• Success of the integrated system dependent on regulatory approval

News Market Reaction – MDT

+0.66%

1 alert

+0.66% News Effect

On the day this news was published, MDT gained 0.66%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

GALWAY, Ireland, April 24, 2025 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it has submitted 510(k) applications to the U.S. Food and Drug Administration (FDA) seeking clearance for an interoperable pump. FDA clearance of this pump would pave the way for system integration with a continuous glucose monitoring (CGM) sensor based on Abbott's most advanced CGM platform.

The submissions included a 510(k) application for its MiniMed™ 780G pump as an alternate controller enabled (ACE) insulin pump and a separate 510(k) application for its SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC).

"We understand how meaningful these advancements are, and we're working with urgency to bring enhanced CGM options to our customers," said Que Dallara, EVP & president, Medtronic Diabetes. "This collaboration with Abbott marks an important step forward in providing innovative solutions and more choice for our customers."

This milestone follows the announcement last August that the companies will collaborate on an integrated system based on Abbott's most advanced CGM platform. Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic smart dosing devices and software across both automated insulin delivery and smart multiple daily injections systems. These systems, including the Abbott CGM, will be sold exclusively by Medtronic.

More details will be shared when FDA clearance is secured.

About the Diabetes Business at Medtronic (www.medtronicdiabetes.com)
Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn.

Any forward-looking statements, including, but not limited to, statements regarding the partnership between Medtronic and Abbott, strategic and other potential benefits of the partnership, Abbott's products and product candidates, and other statements about Medtronic managements' future expectations, beliefs, goals, plans or prospects, are subject to risks and uncertainties including, but not limited to, the ability to obtain regulatory approvals, and other risks and uncertainties such as those described in Medtronic's reports and other filings with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Medtronic cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Medtronic undertakes no obligation to update or revise any of these statements except to the extent required by law.

Contacts:
Janet Cho
Public Relations
+1-818-403-7028

Ryan Weispfenning
Investor Relations
+1-763-505-4626

View original content to download multimedia:https://www.prnewswire.com/news-releases/medtronic-advances-abbott-cgm-partnership-with-fda-submission-of-interoperable-insulin-pump-302437337.html

SOURCE Medtronic plc

FAQ

What is the significance of Medtronic's FDA submission for the interoperable insulin pump?

The FDA submission is important as it would enable integration between Medtronic's insulin pump system and Abbott's advanced CGM platform, potentially offering diabetes patients a more comprehensive treatment solution.

What products are included in MDT's 510(k) FDA submission?

The submission includes the MiniMed™ 780G pump as an ACE insulin pump and the SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC).

How will the Abbott-Medtronic partnership affect product distribution?

The integrated systems, including Abbott's CGM technology, will be sold exclusively through Medtronic's distribution channels.

When was the Abbott-Medtronic CGM partnership first announced?

The collaboration between Abbott and Medtronic was initially announced in August 2024.