Medtronic Diabetes resolves warning letter, clearing path for future innovations

Rhea-AI Summary

Medtronic plc (NYSE:MDT) has resolved a warning letter from the FDA regarding its Diabetes headquarters in Northridge, California, which was received in December 2021. The FDA's decision comes shortly after the agency approved the MiniMed™ 780G system, the first automated insulin delivery system with real-time meal detection technology. The new system adjusts glucose levels automatically every five minutes, addressing significant needs in diabetes management. Medtronic expresses gratitude for the collaborative efforts with the FDA, which enable the company to focus on delivering innovative solutions for diabetes patients. This resolution marks a crucial step for Medtronic's Diabetes division, ensuring adherence to quality standards and paving the way for future advancements.

Positive

• FDA lifted warning letter, indicating compliance with regulatory standards.
• Approval of MiniMed™ 780G system, enhancing diabetes management with meal detection technology.

Negative

• None.

Resolution follows the recent FDA approval of the MiniMed™ 780G system featuring the world's first and only automated insulin delivery system with real-time meal detection technology*

DUBLIN, April 25, 2023 /PRNewswire/ -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced that the U.S. Food and Drug Administration (FDA) lifted the warning letter received at the company's Diabetes headquarters in Northridge, California, in December 2021. This follows on the heels of last week's FDA approval of the MiniMed^TM 780G system, the world's first and only automated insulin delivery system with meal detection technology* that provides automatic adjustments and corrections^† to glucose levels every 5 minutes.^§  

The resolution of the warning letter follows ongoing remediation actions from the company and proactive actions to continue to strengthen its quality systems. All regulatory restrictions associated with the warning letter have been resolved.

"We're very thankful to the agency for working with us so collaboratively to ensure we're able to work as quickly as possible to address the needs of the diabetes community," said Que Dallara, EVP and President of Medtronic Diabetes. "Clearing this latest regulatory milestone allows us to focus on what's most important – delivering innovations that address unmet needs for the individuals with diabetes we have the privilege to serve. It's an honor that we never take for granted and our commitment is to ensure we're putting patients first and prioritizing safety and quality above all." 

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 Dublin, 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 90,000+ 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 Twitter and LinkedIn.

*Taking a bolus 15 – 20 minutes before a meal helps to keep blood sugar levels under control after eating.
† Refers to auto correct, which provides bolus assistance. Can deliver all auto correction doses automatically without user interaction, feature can be turned on and off.
§ Refers to SmartGuard™ feature. Individual results may vary.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Contacts:
Janet Cho	Ryan Weispfenning
Public Relations	Investor Relations
+1-818-403-7028	+1-763-505-4626

 

 

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SOURCE Medtronic plc

FAQ

What recent FDA action did Medtronic (MDT) announce regarding its Diabetes division?

Medtronic announced the resolution of an FDA warning letter at its Diabetes headquarters in Northridge, California.

What is the MiniMed™ 780G system approved by the FDA?

The MiniMed™ 780G system is the world's first automated insulin delivery system with real-time meal detection technology.

When did Medtronic (MDT) receive the FDA warning letter?

Medtronic received the FDA warning letter in December 2021.

How often does the MiniMed™ 780G system adjust glucose levels?

The MiniMed™ 780G system automatically adjusts glucose levels every five minutes.

What does the resolution of the FDA warning letter allow Medtronic (MDT) to do?

The resolution allows Medtronic to focus on delivering innovations that address unmet needs in diabetes care.