Dive Brief:

• Medtronic has received Food and Drug Administration approval for a version of its latest glucose sensor that can pair with the company’s insulin pumps.
• The device, called Simplera Sync, can be used with Medtronic’s MiniMed 780G insulin pumps as part of an automated insulin delivery system, the company said Friday.
• Medtronic is planning a limited launch of the sensor starting this fall. CEO Geoff Martha told investors in February that the company expects Simplera Sync, and a new glucose monitor being developed with Abbott, to grow the company’s U.S. diabetes business.

Dive Insight:

Medtronic has been working to catch up its diabetes business to the competition since the company resolved a warning letter from the FDA in 2023. Shortly before the warning letter was lifted, Medtronic received FDA approval for its 780G insulin pump, which had been under review since 2021. At the time, analysts with RBC Capital Markets said the new pump should help Medtronic turn around its diabetes business, but the company needed a smaller glucose sensor to compete more effectively. 

Last summer, Medtronic received FDA approval for its Simplera Sync sensor, which was smaller than its previous continuous glucose monitors and did not require finger sticks or tape. The latest update allows the sensor to be used with Medtronic’s insulin pumps. 

Medtronic said its 780G system includes meal detection technology, which detects rising sugar levels and delivers more insulin as needed, even when users forget to dose insulin for meals or underestimate carbs. It also allows for glucose targets as low as 100 mg/dL. 

Medtronic plans to seek an expanded label for its 780G pump for people with Type 2 diabetes, Martha told investors in February. The company is also partnering with competitor Abbott to make a CGM that will only work with Medtronic devices.