Intuitive Surgical Shares May Rise as FDA Clears SureForm 45 Stapler

Intuitive Surgical ISRG recently announced that it has received FDA clearance for the first stapler specifically designed for use with single-port (SP) robotic surgical systems. The SureForm 45 stapler is engineered to work with the da Vinci SP platform, expanding the capabilities of minimally invasive procedures in narrow surgical spaces and enabling greater precision and access for surgeons.

This regulatory milestone marks a significant advancement in Intuitive Surgical’s innovation journey and reinforces its leadership in robotic-assisted surgery. The stapler’s curved-tip design, along with advanced smart features and robotic articulation, is expected to enhance surgical performance, improve patient outcomes, and broaden the range of procedures that can be performed using single-port technology.

Likely Trend of ISRG Stock Following the News

Following the announcement, shares of the company closed flat at $493.60 on Friday. In the year-to-date period, ISRG shares have lost 5.4% compared with the industry’s 12.5% decline. The S&P 500 decreased 9.1% in the same time frame.

However, the FDA clearance of Intuitive Surgical’s SureForm 45 stapler for SP robotic systems positions the company to further solidify its dominance in the robotic-assisted surgery market. By expanding the functionality of the da Vinci SP platform, Intuitive Surgical can drive increased adoption among hospitals and surgical centers seeking to offer more advanced, minimally invasive procedures. This could translate into higher recurring revenue from instrument and accessory sales, greater utilization of existing surgical systems, and a stronger competitive moat.

Meanwhile, ISRG currently has a market capitalization of $175.81 billion. ISRG’s earnings have surpassed its estimates for all the trailing four quarters, delivering an average surprise of 14.9%.

More on ISRG’s SP SureForm 45 Stapler

Designed for thoracic, colorectal, and urologic procedures, the SP SureForm 45 is the first fully wristed stapler developed specifically for single-port robotic platforms. Its integration enables surgeons to perform complex stapling maneuvers through a single incision, reducing the invasiveness of procedures while maintaining high surgical precision and control. This evolution is significant in advancing minimally invasive surgery, particularly in anatomically restricted spaces where access is a challenge.

The SP SureForm 45 incorporates SmartFire technology, a key differentiator that enhances surgical safety and consistency. This proprietary system continuously monitors tissue compression before and during the stapling process, optimizing firing to maintain staple line integrity and minimize tissue trauma across variable tissue thicknesses. By providing surgeons with the ability to control stapling from the da Vinci SP console rather than relying on a bedside assistant, this stapler improves workflow efficiency and reduces operating time. Its wristed articulation further expands the range of surgical motions, enabling more natural and flexible instrument movement within confined anatomical zones.

The da Vinci SP system itself is a major innovation in robotic surgery, allowing up to three wristed instruments and a 3D HD camera to operate through a single small incision. This single-port approach minimizes external instrument collisions and enables triangulation inside the body, which is particularly advantageous in tight surgical fields. Already cleared in the United States for urology, thoracic, and colorectal procedures and approved for broader use in Europe and Asia, the SP system is rapidly gaining traction as hospitals seek solutions that enhance surgical outcomes and patient recovery.

Favorable Industry Prospects for ISRG

Per a report by Grand View Research, the global minimally invasive surgical instruments market size was estimated at $31.65 billion in 2023 and is anticipated to witness a CAGR of 10.4% from 2024 to 2030.

The minimally invasive surgical instruments market is growing due to rising surgical volumes, demand for faster recovery, and advancements in robotic and image-guided technologies. Aging populations, better outcomes, and supportive healthcare policies are also key drivers.

ISRG’s Zacks Rank & Stocks to Consider

ISRG carries a Zacks Rank #3 (Hold) at present.

Some better-ranked stocks from the broader medical space are AngioDynamics ANGO, Veeva Systems VEEV and Masimo MASI.

AngioDynamics, currently sporting a Zacks Rank #1 (Strong Buy), reported third-quarter fiscal 2025 adjusted earnings per share (EPS) of 3 cents against the Zacks Consensus Estimate of a loss of 13 cents. Revenues of $72 million beat the Zacks Consensus Estimate by 2%. You can see the complete list of today’s Zacks #1 Rank stocks here.

ANGO has an estimated fiscal 2026 earnings growth rate of 27.8% compared with the S&P 500 Composite’s 10.5% growth. The company surpassed earnings estimates in each of the trailing four quarters, with the average surprise being 70.9%.

Veeva Systems, sporting a Zacks Rank #1 at present, posted fourth-quarter fiscal 2025 adjusted EPS of $1.75, exceeding the Zacks Consensus Estimate by 10.1%. Revenues of $720.9 million surpassed the Zacks Consensus Estimate by 3.2%.

VEEV has an estimated long-term earnings growth rate of 26.6% compared with the industry’s 20.8% growth. The company’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 7.9%.

Masimo, currently sporting a Zacks Rank #1, reported a fourth-quarter 2024 adjusted EPS of $1.80, which surpassed the Zacks Consensus Estimate by 20.8%. Revenues of $600.7 million topped the Zacks Consensus Estimate by 0.8%.

MASI has an estimated earnings yield of 3.5% for fiscal 2025 compared with the industry’s 3.6% yield. The company’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 14.4%.

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

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