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MDT Stock Gains From FDA Approval for Its InPen App
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Medtronic plc (MDT - Free Report) recently received Food and Drug Administration (“FDA”) clearance for its new InPen app, which features missed meal dose detection. This latest FDA clearance should pave the way for the launch of the company’s Smart MDI system, which combines the InPen smart insulin pen with its newest Simplera continuous glucose monitor (CGM).
Medtronic will initiate a limited market release with existing standalone CGM and InPen customers, followed by a broad commercial launch.
MDT’s Likely Stock Trend Following the News
Subsequent to the news, the share price of MDT moved north 0.7% to $84.74 yesterday.
The latest development is likely to boost the company’s Diabetes segment. The company is gaining a high level of synergies from its continuous effort to develop diabetes management products. Medtronic is experiencing continued adoption of the MiniMed 780G automated insulin delivery system, along with increasing CGM attachment rates and the continued rollout of Simplera Sync. Accordingly, we expect market sentiment toward MDT stock to continue to remain positive surrounding this news.
Medtronic boasts a market capitalization of $116.20 billion. The company delivered an average earnings surprise of 3.07% in the trailing four quarters.
Importance of the FDA Approval
The FDA nod is a significant leap forward for those on multiple daily injections, offering intelligent dosing insights and simplifying diabetes management. For diabetic patients who need insulin injections daily, bolusing before a meal is essential as it helps regulate glucose levels and prevents blood sugar spikes after eating. Minimizing the frequency of these glucose spikes reduces the risk of both short and long-term complications. It is estimated that individuals with diabetes regularly miss one out of three doses. The InPen app’s Missed Dose alert function helps minimize the frequency of these glucose highs.
With this clearance, the Smart multiple daily injection (MDI) system will be the first in the market to recommend corrections for missed or inaccurate insulin doses. It provides real-time, personalized insights for individuals on MDI therapy.
Industry Prospects Favor Medtronic
Per a Grand View Research report, the global diabetes devices market was valued at $30.31 billion in 2023 and is projected to witness a compound annual growth rate of 7.45% from 2024 to 2030. The market is primarily driven by the growing prevalence of diabetes, advanced technology, the growing usage of insulin-delivery devices and the rise in obesity rates.
Other Recent Developments by MDT
Last month, Medtronic shared long-term data from its SPYRAL HTN-ON MED clinical trial. The trial data showed significantly greater reductions in 24-hour ambulatory systolic blood pressure and office-based systolic blood pressure in subjects who underwent radiofrequency renal denervation with the company’s Symplicity Spyral renal denervation system compared to sham patients at two years. The findings were presented at the 2024 Transcatheter Cardiovascular Therapeutics Conference.
Image Source: Zacks Investment Research
The same month, Medtronic received FDA approval for its Affera Mapping and Ablation System with Sphere-9 Catheter. It is an all-in-one, high-density mapping and pulsed-field and radiofrequency ablation catheter for treating persistent atrial fibrillation and RF ablation of cavotricuspid isthmus-dependent atrial flutter.
MDT Share Price Performance
In the past year, MDT’s shares have risen 8.1% compared with the industry’s 19.8% growth.
MDT’s Zacks Rank and Key Picks
Medtronic currently carries a Zacks Rank #3 (Hold).
Haemonetics has an earnings yield of 5.02% compared with the industry’s 1.18%. Its earnings surpassed the Zacks Consensus Estimate in each of the trailing four quarters, the average surprise being 19.39%. Its shares have risen 1.8% compared with the industry’s 23.1% growth in the past year. Estimates for Haemonetics’ 2025 EPS have moved north 0.4% to $4.59 in the past 30 days.
Estimates for Globus Medical’s 2024 EPS have remained constant at $2.84 in the past 30 days. Shares of the company have surged 60.6% in the past year compared with the industry’s growth of 32.7%. GMED’s earnings surpassed estimates in each of the trailing four quarters, the average beat being 12.1%. In the last reported quarter, it delivered an earnings surprise of 10.3%.
Estimates for ResMed’s fiscal 2025 EPS have risen 2.7% in the past 30 days. Shares of the company have surged 86.3% in the past year compared with the industry’s 32.1% growth. RMD’s earnings surpassed estimates in each of the trailing four quarters, the average beat being 6.4%. In the last reported quarter, it delivered an earnings surprise of 8.4%.
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MDT Stock Gains From FDA Approval for Its InPen App
Medtronic plc (MDT - Free Report) recently received Food and Drug Administration (“FDA”) clearance for its new InPen app, which features missed meal dose detection. This latest FDA clearance should pave the way for the launch of the company’s Smart MDI system, which combines the InPen smart insulin pen with its newest Simplera continuous glucose monitor (CGM).
Medtronic will initiate a limited market release with existing standalone CGM and InPen customers, followed by a broad commercial launch.
MDT’s Likely Stock Trend Following the News
Subsequent to the news, the share price of MDT moved north 0.7% to $84.74 yesterday.
The latest development is likely to boost the company’s Diabetes segment. The company is gaining a high level of synergies from its continuous effort to develop diabetes management products. Medtronic is experiencing continued adoption of the MiniMed 780G automated insulin delivery system, along with increasing CGM attachment rates and the continued rollout of Simplera Sync. Accordingly, we expect market sentiment toward MDT stock to continue to remain positive surrounding this news.
Medtronic boasts a market capitalization of $116.20 billion. The company delivered an average earnings surprise of 3.07% in the trailing four quarters.
Importance of the FDA Approval
The FDA nod is a significant leap forward for those on multiple daily injections, offering intelligent dosing insights and simplifying diabetes management. For diabetic patients who need insulin injections daily, bolusing before a meal is essential as it helps regulate glucose levels and prevents blood sugar spikes after eating. Minimizing the frequency of these glucose spikes reduces the risk of both short and long-term complications. It is estimated that individuals with diabetes regularly miss one out of three doses. The InPen app’s Missed Dose alert function helps minimize the frequency of these glucose highs.
With this clearance, the Smart multiple daily injection (MDI) system will be the first in the market to recommend corrections for missed or inaccurate insulin doses. It provides real-time, personalized insights for individuals on MDI therapy.
Industry Prospects Favor Medtronic
Per a Grand View Research report, the global diabetes devices market was valued at $30.31 billion in 2023 and is projected to witness a compound annual growth rate of 7.45% from 2024 to 2030. The market is primarily driven by the growing prevalence of diabetes, advanced technology, the growing usage of insulin-delivery devices and the rise in obesity rates.
Other Recent Developments by MDT
Last month, Medtronic shared long-term data from its SPYRAL HTN-ON MED clinical trial. The trial data showed significantly greater reductions in 24-hour ambulatory systolic blood pressure and office-based systolic blood pressure in subjects who underwent radiofrequency renal denervation with the company’s Symplicity Spyral renal denervation system compared to sham patients at two years. The findings were presented at the 2024 Transcatheter Cardiovascular Therapeutics Conference.
Image Source: Zacks Investment Research
The same month, Medtronic received FDA approval for its Affera Mapping and Ablation System with Sphere-9 Catheter. It is an all-in-one, high-density mapping and pulsed-field and radiofrequency ablation catheter for treating persistent atrial fibrillation and RF ablation of cavotricuspid isthmus-dependent atrial flutter.
MDT Share Price Performance
In the past year, MDT’s shares have risen 8.1% compared with the industry’s 19.8% growth.
MDT’s 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) , Globus Medical (GMED - Free Report) and ResMed (RMD - Free Report) . While ResMed sports a Zacks Rank #1 (Strong Buy) at present, Haemonetics and Globus Medical carry a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
Haemonetics has an earnings yield of 5.02% compared with the industry’s 1.18%. Its earnings surpassed the Zacks Consensus Estimate in each of the trailing four quarters, the average surprise being 19.39%. Its shares have risen 1.8% compared with the industry’s 23.1% growth in the past year. Estimates for Haemonetics’ 2025 EPS have moved north 0.4% to $4.59 in the past 30 days.
Estimates for Globus Medical’s 2024 EPS have remained constant at $2.84 in the past 30 days. Shares of the company have surged 60.6% in the past year compared with the industry’s growth of 32.7%. GMED’s earnings surpassed estimates in each of the trailing four quarters, the average beat being 12.1%. In the last reported quarter, it delivered an earnings surprise of 10.3%.
Estimates for ResMed’s fiscal 2025 EPS have risen 2.7% in the past 30 days. Shares of the company have surged 86.3% in the past year compared with the industry’s 32.1% growth. RMD’s earnings surpassed estimates in each of the trailing four quarters, the average beat being 6.4%. In the last reported quarter, it delivered an earnings surprise of 8.4%.