Medtronic Submits FDA 510(k) Applications for Interoperable Insulin Pump Integrated with Abbott's Advanced CGM Platform

Medtronic Announces Two 510(k) Submissions to FDA for Interoperable Insulin Pump; If Approved, the Product Will Enable System Integration with CGM Sensors Developed Based on Abbott's Advanced Continuous Glucose Monitoring (CGM) Platform.

This submission includes: the 510(k) application for the MiniMed 780G insulin pump as an Alternate Controller Enabled (ACE) pump, and the standalone 510(k) application for the SmartGuard algorithm as an interoperable Automated Glycemic Controller (iAGC).

Executive Evaluation

"We deeply understand the significance of these technological breakthroughs and are fully committed to advancing innovation to provide customers with higher-quality CGM solutions. The collaboration with Abbott marks an important step in our effort to offer customers innovative solutions and more choices."

---Que Dallara  Executive Vice President and President of Medtronic Diabetes Business

Abbott's CGM technology is one of the best blood glucose monitoring technologies currently available, generating billions of dollars in revenue annually for Abbott (just in the first quarter of this year alone).Degree brings17Billion USD in revenue). Due to dual recognition in both clinical and market aspects, all mainstream global insulin companies have chosen to cooperate with Abbott, such asInsulet, Tandem Diabetes Care, and Beta Bionics, etc.

However, Medtronic, as the largest insulin pump manufacturer, has chosen to adopt its own CGM technology instead of Abbott's or Dexcom's. But its own CGM product's accuracy in blood glucose monitoring isAbbott or Dexcom still has considerable gaps. With the rapid advancements in insulin pump and CGM technology today, Medtronic's failure to make timely adjustments has significantly weakened its position in the insulin pump field, especially in...Insulet'sUnder the impact of Omnipod 5.

As the market share was being eroded by competitors, Medtronic's senior management began to choose change. In August last year, Medtronic and AbbottJointly Announce In-Depth Collaboration in Diabetes Field --- Development of Integrated Systems Based on Abbott's Most Advanced CGM Platform. According to the agreement, Abbott will supply Medtronic with CGM products exclusively compatible with its smart drug delivery devices and software systems (covering automated insulin infusion and smart multiple daily injection systems). The complete system, including Abbott's CGM, will be exclusively sold by Medtronic.

In 9 months, Medtronic will be based onAbbott CGM SystemThe submission of MiniMed 780G for FDA registration not only reflects Medtronic's efficiency but also demonstrates the company's seriousness about this collaboration. Medtronic hopes that its partnership with Abbott will solidify its position in the insulin pump market and reverse its decline.