MDT Stock May Benefit From New Regulatory Wins for Its MiniMed 780G

Medtronic plc MDT recently announced two regulatory milestones for its MiniMed 780G system portfolio. The FDA has cleared the company’s SmartGuard algorithm as an interoperable automated glycemic controller, enabling integration with Abbott’s ABT Instinct sensor for type 1 diabetes. In addition, the MiniMed 780G system secured approval for use in adults 18 and above, with insulin-requiring type 2 diabetes.

The developments represent a significant advancement in Medtronic’s efforts to expand the proven performance and outcomes of its MiniMed 780G automated insulin delivery (AID) system to more people living with diabetes.

Likely Trend of MDT Stock Following the News

Following the announcement on Sept. 2, MDT shares dipped 1.2%, closing at $92.25 on Wednesday. On a promising note, the Diabetes business is consistently growing above the company average due to the strength of the 780G system and Simpler Sync sensor in international markets. Medtronic has heavily invested in Diabetes over the past few years and is now entering a strong innovation cycle with both new technology and new indications. We expect these latest milestones to support the company’s revenue growth and also help a rebound in the stock’s performance.  

Medtronic has a market capitalization of $118.33 billion. The Zacks Consensus Estimate for the company’s fiscal 2026 revenues indicates 6.8% growth over fiscal 2025. It surpassed earnings estimates in each of the trailing four quarters, the average surprise being 2.20%. 

More on MDT’s Regulatory Achievements

The Instinct sensor, designed exclusively by Abbott for MiniMed AID and Smart MDI systems, is the world's smallest, thinnest, most discreet integrated CGM and offers a wear time of up to 15 days. The latest clearance, along with the previously cleared MiniMed 780G insulin pump as an alternate controller enabled (ACE) pump, completes the Medtronic FDA pre-market approval pathway for the Instinct sensor integration with the MiniMed 780G system for people living with type 1 diabetes. 

In the coming weeks, Medtronic and Abbott plan to complete their necessary compliance documentation to enable sensor integration and marketing. Once complete, the regulatory process will be concluded, after which ordering for the Instinct sensor with the MiniMed 780G system will begin. Existing customers will have priority access through the Innovations Program. Pre-orders for the Simplera Sync sensor are also expected to open later this month.

Meanwhile, the FDA’s approval of the MiniMed 780G system for people with insulin-requiring type 2 diabetes makes it the first and only AID system with Meal Detection technology available to this population. People living with type 2 diabetes who require insulin encounter daily challenges that affect both their physical health and emotional well-being — including frequent injections, meal planning and glucose monitoring. Clinical evidence demonstrates that use of the MiniMed 780G system can improve glycemic outcomes and reduce the treatment burden.

The MiniMed 780G system is currently available for type 2 diabetes with the Guardian 4 sensor and will be available with the Simplera Sync sensor when pre-orders begin later this month. Medtronic also plans to submit 510(k) applications seeking clearance for an interoperable pump indicated for type 2 diabetes, which would enable future integration with the Instinct sensor.

Industry Prospects Favor MDT

According to Precedence Research, the global diabetes device market was valued at $32.74 billion in 2024 and is expected to grow at a compound annual growth rate of 7.7% through 2034.

Some of the main factors driving the market’s growth are the rising prevalence of obesity among the population, growing health consciousness, increasing awareness regarding diabetes, technological advancements in diabetes monitoring devices, easy availability of diabetes devices and high personal disposable income.

Other Developments at MDT

In July, Medtronic secured CE Mark to expand indications of the MiniMed 780G system for use by individuals aged two years and older, during pregnancy, as well as type 2 insulin-requiring diabetes. To gain CE Mark for this expansion of indications, published clinical data in two-to-six-year-olds, pregnant women and people living with type 2 diabetes were reviewed. 

MDT Stock Price Performance

In the past year, Medtronic shares have risen 3.9% compared with the industry’s 3.4% 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 include Envista NVST and Phibro Animal Health PAHC. Both carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Estimates for Envista’s 2025 earnings per share have increased 7.6% in the past 30 days. Shares of the company have rallied 19.1% in the past year compared with the industry’s 3.2% rise. Its earnings yield of 5.4% also outpaced the industry’s -0.9% yield. NVST’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 16.5%.

Estimates for Phibro Animal Health’s fiscal 2026 earnings per share have climbed 5 cents to $2.35 in the past 30 days. Shares of the company have surged 100.7% in the past year compared with the industry’s 3.2% growth. PAHC’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 27.9%. In the last reported quarter, it delivered an earnings surprise of 9.6%.

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This article originally published on Zacks Investment Research (zacks.com).

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