MiniMed Files IPO Prospectus: First and Only AID System for Type 2 Diabetes with FDA Breakthrough Approvals

Source: Medical Device Business Review

September 2, 2025, MedtronicMedtronic announces that its core diabetes management product, the MiniMed™ 780G automated insulin delivery system, has received two key approvals from the U.S. FDA, marking a significant advancement for the system.Applicable PopulationAndTechnical CompatibilityA major breakthrough has been achieved.

This approval further solidifies Medtronic's leadership position in the diabetes technology field and injects strong growth momentum into its soon-to-be independent diabetes business.

"These milestones mark an important step forward. By integrating the Instinct sensor and expanding the MiniMed 780G system to type 2 diabetes patients, we are advancing the smart dosing ecosystem, aiming to provide more choices, greater flexibility, and a more seamless experience."Que Dallara, Executive Vice President and President of Medtronic's Diabetes Business and Incoming CEO of MiniMed, stated。

"We are delighted to expand our solution ecosystem to the same platform, providing customers with reliable services around the clock."

Notably, Medtronic and Abbott established a global partnership over a year ago, pairing Abbott's Continuous Glucose Monitor (CGM) with Medtronic's insulin delivery system.

The collaboration aims to jointly develop systems based on Abbott's FreeStyle Libre CGM, Medtronic's automated insulin delivery technology (the latest generation being the MiniMed 780G), and smart insulin pen systems (such as the InPen system).

Last month, Medtronic unveiled its Instinct sensor, designed for its system, for the first time.Chris Scoggins, Executive Vice President of Abbott Diabetes Care, said earlier this year that the sensor, built on Abbott's FreeStyle Libre platform, embodies "the power of partnership."

Medtronic rated Instinct as the world's smallest, thinnest, and most discreet integrated Continuous Glucose Monitoring (CGM) product, with a maximum wear time of up to 15 days.

In the coming weeks, the two companies plan to complete the required compliance documents to proceed with integration and marketing. This will finalize the regulatory process, at which point they are expected to begin ordering Instincts equipped with the MiniMed 780G. The company also plans to start taking pre-orders for the Simplera Sync sensor later this month.

Scoggins said, "We are working together to provide the best service for people with diabetes."Abbott's biowearable technology has long been a benchmark for accurate, convenient, and easy-to-use continuous glucose monitoring. Integrating it with the MiniMed™ 780G system aims to reduce the mental burden of daily management, making life easier for people with diabetes."

Medtronic's diabetes business is one of the largest diabetes technology companies in the world, and Medtronic is currently preparing for the spin-off of its diabetes business.June 12, local time in the United StatesAnnounce,The new diabetes company after its spin-off will be renamed MiniMed.

Image source: PR Newswire

This name pays tribute to the company's roots.This reflects both the company's original name before its acquisition by Medtronic in 2001 and its long history of being at the forefront of the global diabetes care transformation for 40 years.

The new company will still be located in Northridge, California, with more than 8,000 employees. Currently, this business accounts for 8% of Medtronic's fiscal year 2025 revenue and 4% of the company's divisional operating profit.

In the future, MiniMed will continue to advance its business portfolio, which includes diabetes management tools such as automated insulin pumps, smart insulin pens, and continuous glucose monitors (CGM).

Que Dallara, current Executive Vice President of Medtronic and President of the Diabetes Business, as well as incoming CEO of MiniMed, stated:

 “Our brand began in 1983,At that time, the visionary entrepreneur Alfred E. Mann founded MiniMed. We are delighted to commemorate our 40 years of brilliant history with a name that carries deep significance and trust."As we step into this exciting new chapter, we will remain steadfast in our commitment to fulfilling our mission of making diabetes more predictable and enabling everyone to fully enjoy life."