Medtronic Receives CE Mark for Simplera™ Continuous Glucose Monitoring System

Sep 23, 2023 00:02 CST Updated 00:02

Medtronic

Medical Device Manufacturer

Source: Siyu MedTech; Editor: Jacky

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On September 21, 2023, Medtronic (NYSE: MDT) announced that its new integrated, disposable Simplera™ Continuous Glucose Monitor (CGM) received CE certification.

# Simplera™ Continuous Glucose Monitor Receives CE Approval

Medtronic's latest tape-free Continuous Glucose Monitor (CGM) seamlessly integrates with the InPen™ smart insulin pen, providing real-time, personalized dosing guidance to help simplify diabetes management. Medtronic will prepare for a phased launch of the product at the 59th Annual Meeting of the European Association for the Study of Diabetes (EASD), scheduled to take place from October 2 to 6, 2023, in Hamburg, Germany.

German endocrinologist Dr. Sandra Schlüter stated that diabetes patients may feel overwhelmed by the numerous treatment steps they need to follow daily. It’s great that Medtronic has introduced this solution, which provides real-time, personalized guidance to help patients stay healthy. For example, when the system detects that a patient is eating and their blood glucose level is trending upward, it will alert the patient, helping simplify diabetes management.

▲Image source: official website (same below)

Medtronic Diabetes President Que Dallara stated that despite the rapid adoption of continuous glucose monitors (CGM) over the past decade, less than 30% of individuals using CGM for MDI therapy achieve their glucose targets, highlighting a significant unmet need. The company is excited to help more patients achieve their glucose goals with this product. The advanced algorithm used in the InPen™ smart insulin pen is supported by the company’s smallest and most comfortable CGM to date. The latest addition to the overall product portfolio, the smart MDI solution, demonstrates Medtronic's commitment to meeting patient needs throughout the diabetes management journey with simplified solutions, helping them live easier lives.

Simplera™ is suitable for children over the age of 2 and is compatible with iOS and Android. Simplera™ has not yet received FDA approval and is limited to investigational use in the United States. Medtronic's Automated Insulin Delivery (AID) system (which can integrate with this next-generation sensor) is currently undergoing CE Mark review and is not yet available in the U.S. or Europe.

# About Smart MDI

Medtronic's Smart MDI System is the first to seamlessly integrate real-time CGM with a smart insulin pen, powered by an adjustable algorithm that provides personalized dosing recommendations.InPen™With the newSimplera™When combined with CGM, it provides users with operational recommendations, reduces guesswork and complex manual calculations, and helps simplify diabetes management.

# About Medtronic's Diabetes Business

The mission of Medtronic's Diabetes Business Unit is to support patients with the most advanced diabetes technology, enabling them to live life on their own terms and thereby reducing the burden of diabetes. For over 40 years, Medtronic has been a leader in innovation within its field, committed to designing the future of diabetes management through next-generation sensors (CGM), smart dosing systems, and the power of data science and artificial intelligence, all while consistently prioritizing customer experience.

In August 2023, Medtronic announced its first-quarter financial report for the fiscal year 2024 (FY24) ended July 28, 2023. The Diabetes business unit achieved revenue of $578 million (approximately RMB 4.21 billion) in the first quarter, representing a reported growth of 6.8% and organic growth of 6.3% year-over-year. The division demonstrated strong growth momentum across all markets. It is reported that Medtronic also expects to complete the acquisition of patch pump manufacturer EOFlow by the end of this year.

# About Medtronic

Medtronic is a global leading medical device company dedicated to improving human health and extending life. The company provides a variety of innovative medical solutions in more than 150 countries and regions, covering fields such as cardiovascular, neurological, diabetes, and surgical. Medtronic's total revenue for the fiscal year 2023 was $31.2 billion (approximately 227 billion yuan), with a market value of approximately $150 billion (approximately 1.09 trillion yuan).

Editor-in-Chief | Zhao Qing Reviewed by | Yi He Typeset by | Miya