ISRG's da Vinci Gains FDA Nod for Cardiac Surgery: TAM Growth Ahead?

Intuitive Surgical ISRG is positioning cardiac surgery as a long-term growth lever for the da Vinci 5 platform following recent regulatory progress. The company recently received FDA clearance for several cardiac procedures using da Vinci 5 with non-Force Feedback instruments, marking an early step in expanding robotic surgery into a complex new disease category.

Although the opportunity remains modest today, management views the addressable market as significant over time. In 2025, approximately 17,000 cardiac procedures were performed globally using earlier da Vinci systems, such as Si and Xi. However, Intuitive Surgical estimates the immediate opportunity for the da Vinci 5 system at roughly 160,000 procedures annually in markets where it is cleared, currently including the United States and South Korea.

The company is approaching the cardiac segment cautiously, given the clinical complexity of minimally invasive cardiac surgery. Intuitive Surgical noted that the expansion will involve a measured rollout supported by dedicated training pathways, reflecting the specialized skills required to perform robotic cardiac procedures safely. These initiatives are expected to include collaboration with surgical societies and structured education programs designed to help hospitals build sustainable robotic cardiac programs.

Beyond training, the roadmap outlines a multiyear development cycle for cardiac-specific instrumentation and technologies, such as Force Feedback instruments and additional accessories tailored to the needs of cardiac surgeons. The company is also refining its digital tools to support procedure planning, intraoperative guidance and broader surgeon adoption.

Taken together, these initiatives suggest that cardiac surgery is unlikely to be a near-term revenue driver but could represent a meaningful new optionality for Intuitive Surgery over the long term. If clinical evidence, surgeon training and instrumentation improvements evolve as planned, cardiac procedures could gradually expand ISRG’s total addressable market (TAM) and reinforce the strategic role of da Vinci 5 in advancing minimally invasive surgery.

Peer Updates

Zimmer Biomet ZBH continues to position its ROSA robotic platform as a long-term growth driver through expanding clinical indications and technology integration. Management highlighted strong robotic capital sales and increasing adoption of its technology and data portfolio during the quarter, reflecting growing hospital interest in robotic-assisted orthopedics.

ZBH is also advancing new applications, such as ROSA Shoulder, as part of a broader innovation cycle aimed at closing portfolio gaps and enabling surgeons to treat additional joint segments robotically. As Zimmer Biomet expands ROSA’s use across knees, shoulders and other orthopedic procedures, it expects robotics to penetrate higher-growth surgical segments, broadening the addressable procedure pool and strengthening the long-term total addressable market.

Stryker SYK is accelerating the clinical scope of its Mako robotic system as the company transitions to the Mako 4 platform. Management highlighted record Mako installations in 2025 and a global installed base exceeding 3,000 systems, alongside rising procedure utilization across hips and knees.

SYK continues expanding Mako’s indications, including advanced primary hips, revision hips, spine and a forthcoming shoulder application expected to be launched on Mako 4. By moving beyond core knee and hip procedures into additional orthopedic segments, Stryker is widening Mako’s procedural reach. These new indications could materially expand the company’s robotic TAM while driving incremental implant pull-through and procedure growth across its orthopedics portfolio.

ISRG’s Price Performance, Valuation and Estimates

Shares of ISRG have gained 12.9% over the past six months against the industry’s 3.2% decline.

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From a valuation standpoint, Intuitive Surgical trades at a forward price-to-earnings ratio of 47.74, above the industry average. But it is still lower than its five-year median of 70.97. ISRG carries a Value Score of F.

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The Zacks Consensus Estimate for Intuitive Surgical’s 2026 earnings implies a 12.7% rise from the year-ago period’s level.

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The stock currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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