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Medtronic (MDT) Gets CE Mark Approval for the New Simplera CGM
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Medtronic plc (MDT - Free Report) recently received CE Mark approval for its new Simplera continuous glucose monitor (CGM). Currently, it is under review with the FDA and is limited to investigational use in the United States.
This latest addition of a Smart MDI (multiple daily injection) solution will boost Medtronic’s Diabetes Operating Unit. The company will begin the phased launch of the Simplera CGM at the European Association for the Study of Diabetes 59th Annual Meeting in Hamburg, Germany, to be held on Oct 2-6, 2023.
News in Detail
The Medtronic Smart MDI system is the first to seamlessly integrate real-time CGM with a smart insulin pen powered by an adjustable algorithm that delivers personalized dosing recommendations. The company’s newest all-in-one, disposable Simplera CGM features a simple, two-step insertion process.
Image Source: Zacks Investment Research
Moreover, the no-fingerstick sensor is 50% smaller than its previous generation and is seamlessly integrated with the InPen smart insulin pen. This provides users with actionable insights that reduce guesswork and complicated manual calculations to help simplify diabetes management.
MDT quotes many research studies, which highlight the significant unmet need for patients with diabetes. Despite the rapid adoption of CGM over the past decade, less than 30% of individuals on MDI therapy using a CGM achieve glycemic targets. Medtronic’s advanced algorithm in InPen, powered by the smallest and most comfortable CGM to date, outlines its commitment to bringing forth simplified solutions to make diabetes management easier for people living with chronic diseases.
Simplera is recommended for ages two and above and is compatible with iOS and Android. Medtronic's automated insulin delivery system integrated with this next-generation sensor is currently under review for CE Mark and is not commercially available in the United States or Europe.
Industry Prospects
Per a Research report, the global CGM devices market was valued at $7.82 million in 2022 and is expected to witness a CAGR of 4.4% by 2030.
Notable Highlights in the Diabetes Business
Medtronic’s Diabetes segment develops, manufactures and markets products and services for the management of Type 1 and Type 2 diabetes, such as insulin pumps, CGM systems, consumables and smart insulin pen systems. In the first quarter of fiscal 2024, the business witnessed strong international growth, led by the continued international expansion of the MiniMed 780G insulin pump system and integrated CGM.
Within the United States, the momentum from the 780G launch also contributed to the segment’s growth. Recently, the company presented a robust collection of new clinical and real-world data on the MiniMed 780G system at the 83rd American Diabetes Association Scientific Sessions held in San Diego, CA. In addition, Medtronic entered into a definitive agreement in May 2023 to acquire EOFlow Co. Ltd., which further expands its Diabetes segment portfolio of products.
Price Performance
In the past six months, MDT shares have increased 3.7% against the industry’s decline of 2.7%.
Zacks Rank and Key Picks
Medtronic currently carries a Zacks Rank #3 (Hold).
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QTRX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 30.39%. In the last reported quarter, it posted an earnings surprise of 55.56%.
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Medtronic (MDT) Gets CE Mark Approval for the New Simplera CGM
Medtronic plc (MDT - Free Report) recently received CE Mark approval for its new Simplera continuous glucose monitor (CGM). Currently, it is under review with the FDA and is limited to investigational use in the United States.
This latest addition of a Smart MDI (multiple daily injection) solution will boost Medtronic’s Diabetes Operating Unit. The company will begin the phased launch of the Simplera CGM at the European Association for the Study of Diabetes 59th Annual Meeting in Hamburg, Germany, to be held on Oct 2-6, 2023.
News in Detail
The Medtronic Smart MDI system is the first to seamlessly integrate real-time CGM with a smart insulin pen powered by an adjustable algorithm that delivers personalized dosing recommendations. The company’s newest all-in-one, disposable Simplera CGM features a simple, two-step insertion process.
Image Source: Zacks Investment Research
Moreover, the no-fingerstick sensor is 50% smaller than its previous generation and is seamlessly integrated with the InPen smart insulin pen. This provides users with actionable insights that reduce guesswork and complicated manual calculations to help simplify diabetes management.
MDT quotes many research studies, which highlight the significant unmet need for patients with diabetes. Despite the rapid adoption of CGM over the past decade, less than 30% of individuals on MDI therapy using a CGM achieve glycemic targets. Medtronic’s advanced algorithm in InPen, powered by the smallest and most comfortable CGM to date, outlines its commitment to bringing forth simplified solutions to make diabetes management easier for people living with chronic diseases.
Simplera is recommended for ages two and above and is compatible with iOS and Android. Medtronic's automated insulin delivery system integrated with this next-generation sensor is currently under review for CE Mark and is not commercially available in the United States or Europe.
Industry Prospects
Per a Research report, the global CGM devices market was valued at $7.82 million in 2022 and is expected to witness a CAGR of 4.4% by 2030.
Notable Highlights in the Diabetes Business
Medtronic’s Diabetes segment develops, manufactures and markets products and services for the management of Type 1 and Type 2 diabetes, such as insulin pumps, CGM systems, consumables and smart insulin pen systems. In the first quarter of fiscal 2024, the business witnessed strong international growth, led by the continued international expansion of the MiniMed 780G insulin pump system and integrated CGM.
Within the United States, the momentum from the 780G launch also contributed to the segment’s growth. Recently, the company presented a robust collection of new clinical and real-world data on the MiniMed 780G system at the 83rd American Diabetes Association Scientific Sessions held in San Diego, CA. In addition, Medtronic entered into a definitive agreement in May 2023 to acquire EOFlow Co. Ltd., which further expands its Diabetes segment portfolio of products.
Price Performance
In the past six months, MDT shares have increased 3.7% against the industry’s decline of 2.7%.
Zacks Rank and Key Picks
Medtronic currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Haemonetics (HAE - Free Report) , Quanterix (QTRX - Free Report) and Intuitive Surgical (ISRG - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Haemonetics stock has risen 21.2% in the past year. Earnings estimates for Haemonetics have increased from $3.74 to $3.82 in 2023 and remained constant at $4.07 in 2024 in the past 30 days.
HAE’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.39%. In the last reported quarter, it posted an earnings surprise of 38.16%.
Estimates for Quanterix’s 2023 loss per share have remained constant at 97 cents in the past 30 days. Shares of the company have surged 188.8% in the past year compared with the industry’s rise of 0.8%.
QTRX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 30.39%. In the last reported quarter, it posted an earnings surprise of 55.56%.
Estimates for Intuitive Surgical’s 2023 earnings have remained constant at $5.57 per share in the past 30 days. Shares of the company have increased 48.8% in the past year compared with the industry’s growth of 3.4%.
ISRG’s earnings beat estimates in three of the trailing four quarters and missed in one, the average surprise being 4.19%. In the last reported quarter, Intuitive Surgical delivered an earnings surprise of 7.58%.