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Medtronic Receives FDA Nod for Altaviva Device: Stock to Gain?

By Zacks Equity Research | September 24, 2025, 8:56 AM

Medtronic plc MDT recently received Food and Drug Administration (“FDA”) approval for the minimally invasive implantable tibial neuromodulation (ITNM) Altaviva device. The therapy is inserted near the ankle and designed to treat urge urinary incontinence. The device represents a transformative milestone, ushering in a new bladder control therapy with advanced features.

The recent development is expected to bolster the company’s Neuromodulation division. 

Likely Trend of MDT Stock Following the News

Following the announcement, MDT shares dipped 0.5%, closing at $95.08 on last Friday. On a promising note, over the past 30 years, Medtronic has established itself as the global leader in neuromodulation by consistently pushing the boundaries of innovation. 

With the introduction of the Altaviva device, MDT has become the only company with a full portfolio of neuromodulation therapies for these bladder control symptoms. We expect the latest milestone achievements to support the company’s revenue growth and help a rebound in the stock’s performance.  

Medtronic has a market capitalization of $121.80 billion. The Zacks Consensus Estimate for fiscal 2026 revenues indicates 6.8% growth over fiscal 2025. MDT beat on earnings in each of the trailing four quarters, the average surprise being 2.20%. 

About MDT’s Altaviva device

The device represents a significant advancement for patients with urge urinary incontinence who often weigh the invasiveness of a therapy and the potential side effects when considering treatment options. The device is inserted near the ankle during a minimally invasive procedure that doesn't require sedation or imaging. It then sits slightly below the skin and above the fascia. It sends electrical impulses to the tibial nerve, helping restore communication between the bladder and the brain to regulate bladder control.

The device is designed to have a 15-year battery lifespan under expected therapy settings and delivers therapy automatically, requiring no daily intervention or manual adjustment from the patient. Recharging will take up to 30 minutes when using the default recharging speed, eliminating the need for daily at-home charging equipment. Designed for real-life needs, the Altaviva device is MRI-compatible, providing patients with peace of mind for planned or unexpected medical imaging. 

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Industry Prospects Favor MDT

Per Medtronic’s management, bladder control problems affect an estimated 43 million, or one in six, U.S. adults. Of those, nearly 16 million people have urge urinary incontinence, a common symptom of overactive bladder (OAB) characterized by a sudden, intense urge to urinate, often followed by involuntary leaks before reaching the bathroom. In addition, per a report by the Grand View Research, the global urinary incontinence therapeutics market size is projected to witness a CAGR of 4.0% from 2024 to 2030, driven by a growing aging population and rising awareness. 

Another Update by MDT

Earlier this month, Medtronic 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 aged 18 and above, with insulin-requiring type 2 diabetes.

MDT Stock Price Performance

In the past year, Medtronic shares have risen 5.8% compared with the industry’s 0.3% 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 Masimo MASI, Phibro Animal Health PAHC and Envista NVST. Masimo, Phibro and Envista carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Masimo’s shares have jumped 18.9% in the past year. Estimates for the company’s 2025 earnings per share have increased 5.2% to $5.24 in the past 30 days. MASI’s earnings beat estimates in each of the trailing four quarters, the average surprise being 13.8%. 

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 76.5% in the past year compared with the industry’s 3.4% growth. PAHC’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 27.9%.

Estimates for Envista’s 2025 earnings per share have increased 7.6% in the past 30 days. Shares of the company have rallied 16.7% in the past year compared with the industry’s 5.2% growth. Its earnings yield of 5.4% has also outpaced the industry’s -0.9%. NVST’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 16.5%.

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Medtronic PLC (MDT): Free Stock Analysis Report
 
Masimo Corporation (MASI): Free Stock Analysis Report
 
Phibro Animal Health Corporation (PAHC): Free Stock Analysis Report
 
Envista Holdings Corporation (NVST): Free Stock Analysis Report

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

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