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Medtronic (MDT) Wins CE Mark for MiniMed 780G With Simplera Sync
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Medtronic plc (MDT - Free Report) recently achieved the CE Mark for the MiniMed 780G system with Simplera Sync, a disposable, all-in-one continuous glucose monitor (CGM) that does not require any fingersticks or over tape. The newest sensor is half the size of previous Medtronic sensors and features an improved user experience with a simple, two-step insertion process.
The latest development will significantly boost the company’s Diabetes business. The MiniMed 780G system with the Simplera Sync sensor will be available in Europe via a limited release in the spring of 2024, followed by an expected phased commercial launch in the summer of 2024.
Significance of Medtronic’s AID System
A challenging aspect of diabetes management lies in counting carbohydrates and dosing the right amount of insulin before consuming snacks and meals. Many people tend to underestimate their carbs, which can lead to high blood sugar (hyperglycemia). Prolonged hyperglycemia can potentially cause serious health problems impacting the eyes, major organs and even cognitive function, which is particularly concerning in developing children.
Image Source: Zacks Investment Research
Medtronic's most advanced insulin delivery system automatically adjusts and corrects glucose levels every five minutes and features meal detection technology. With its responsive algorithm, the MiniMed 780G system can help users reduce post-meal hyperglycemia even when they occasionally forget to bolus or undercount their carbs.
The system, which is available with the world's only seven-day infusion set, also features one of the lowest glucose target settings of any automated insulin delivery (AID) system. With this "treat to target" approach, the system more closely mirrors the glucose levels of someone not living with diabetes. The MiniMed 780G system can also presently be used with the Guardian 4 sensor.
More on the News
Medtronic takes pride that the MiniMed 780G system continues to be the most widely used AID system in Europe since its launch in 2020. With the introduction of the Simplera Sync sensor, the company is now able to extend the proven benefits of the MiniMed 780G system with its newest and most comfortable sensor that can be applied in under 10 seconds.
The Simplera Sync sensor leverages Medtronic's advanced AID algorithm as part of its MiniMed 780G system while having a similar look and feel as the Simplera CGM. The MiniMed 780G system with the Simplera Sync sensor is indicated for ages seven and above and is compatible with iOS and Android. In the United States, the Simplera Sync sensor is not approved by the FDA and is limited to investigational use.
Industry Prospects
Per a Research report, the global CGM device market was valued at $4.29 billion in 2022 and is expected to witness a CAGR of 7.3% by 2030.
Other Highlights of the Diabetes Operating Unit
In September 2023, Medtronic announced the CE Mark approval for the all-in-one, disposable Simplera CGM. The no-fingerstick sensor seamlessly integrates with the InPen smart insulin pen, which provides real-time, personalized dosing guidance to help simplify diabetes management. With less than 30% of individuals on MDI therapy using a CGM tend to achieve glycemic targets, MDT intends to help more people reach their goals with the new Smart MDI (multiple daily injection) solution.
Price Performance
In the past six months, Medtronic shares have dropped 0.7% compared with the industry’s decline of 4.2%.
Zacks Rank and Key Picks
Medtronic currently carries a Zacks Rank #3 (Hold).
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HAE’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 16.1%. In the last reported quarter, it posted an earnings surprise of 5.3%.
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HQY’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 16.5%. In the last reported quarter, it delivered an average earnings surprise of 22.5%.
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Medtronic (MDT) Wins CE Mark for MiniMed 780G With Simplera Sync
Medtronic plc (MDT - Free Report) recently achieved the CE Mark for the MiniMed 780G system with Simplera Sync, a disposable, all-in-one continuous glucose monitor (CGM) that does not require any fingersticks or over tape. The newest sensor is half the size of previous Medtronic sensors and features an improved user experience with a simple, two-step insertion process.
The latest development will significantly boost the company’s Diabetes business. The MiniMed 780G system with the Simplera Sync sensor will be available in Europe via a limited release in the spring of 2024, followed by an expected phased commercial launch in the summer of 2024.
Significance of Medtronic’s AID System
A challenging aspect of diabetes management lies in counting carbohydrates and dosing the right amount of insulin before consuming snacks and meals. Many people tend to underestimate their carbs, which can lead to high blood sugar (hyperglycemia). Prolonged hyperglycemia can potentially cause serious health problems impacting the eyes, major organs and even cognitive function, which is particularly concerning in developing children.
Image Source: Zacks Investment Research
Medtronic's most advanced insulin delivery system automatically adjusts and corrects glucose levels every five minutes and features meal detection technology. With its responsive algorithm, the MiniMed 780G system can help users reduce post-meal hyperglycemia even when they occasionally forget to bolus or undercount their carbs.
The system, which is available with the world's only seven-day infusion set, also features one of the lowest glucose target settings of any automated insulin delivery (AID) system. With this "treat to target" approach, the system more closely mirrors the glucose levels of someone not living with diabetes. The MiniMed 780G system can also presently be used with the Guardian 4 sensor.
More on the News
Medtronic takes pride that the MiniMed 780G system continues to be the most widely used AID system in Europe since its launch in 2020. With the introduction of the Simplera Sync sensor, the company is now able to extend the proven benefits of the MiniMed 780G system with its newest and most comfortable sensor that can be applied in under 10 seconds.
The Simplera Sync sensor leverages Medtronic's advanced AID algorithm as part of its MiniMed 780G system while having a similar look and feel as the Simplera CGM. The MiniMed 780G system with the Simplera Sync sensor is indicated for ages seven and above and is compatible with iOS and Android. In the United States, the Simplera Sync sensor is not approved by the FDA and is limited to investigational use.
Industry Prospects
Per a Research report, the global CGM device market was valued at $4.29 billion in 2022 and is expected to witness a CAGR of 7.3% by 2030.
Other Highlights of the Diabetes Operating Unit
In September 2023, Medtronic announced the CE Mark approval for the all-in-one, disposable Simplera CGM. The no-fingerstick sensor seamlessly integrates with the InPen smart insulin pen, which provides real-time, personalized dosing guidance to help simplify diabetes management. With less than 30% of individuals on MDI therapy using a CGM tend to achieve glycemic targets, MDT intends to help more people reach their goals with the new Smart MDI (multiple daily injection) solution.
Price Performance
In the past six months, Medtronic shares have dropped 0.7% compared with the industry’s decline of 4.2%.
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) , DaVita (DVA - Free Report) and HealthEquity (HQY - Free Report) . Haemonetics and HealthEquity each presently carry a Zacks Rank #2 (Buy), and DaVita sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Haemonetics’ stock has increased 8.7% in the past year. Earnings estimates for Haemonetics have remained constant at $3.89 in 2024 and at $4.15 in 2025 in the past 30 days.
HAE’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 16.1%. In the last reported quarter, it posted an earnings surprise of 5.3%.
Estimates for DaVita’s 2023 earnings per share have remained constant at $8.07 in the past 30 days. Shares of the company have increased 36.5% in the past year compared with the industry’s rise of 10%.
DVA’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 36.6%. In the last reported quarter, it delivered an average earnings surprise of 48.4%.
Estimates for HealthEquity’s 2023 earnings per share have increased from $2.03 to $2.15 in the past 30 days. Shares of the company have increased 12.1% in the past year against the industry’s 2.1% fall.
HQY’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 16.5%. In the last reported quarter, it delivered an average earnings surprise of 22.5%.