Johnson & Johnson’s next-gen surgical robot OTTAVA enters operating rooms for the first time

What is Johnson & Johnson’s OTTAVA robotic system and why is it significant?

Johnson & Johnson MedTech, the medical technology division of Johnson & Johnson, has marked a major milestone in the development of its next-generation robotic platform, OTTAVA. The company has announced the successful completion of the first clinical procedures using the OTTAVA robotic surgical system, ushering in a new chapter in robotic-assisted surgery. The system, which remains under investigational status, is not yet available for commercial sale. However, these initial cases represent critical progress toward regulatory clearance and broader clinical adoption.

The OTTAVA platform is designed to redefine soft-tissue robotic surgery by addressing long-standing limitations in surgical robotics. Unlike existing robotic systems, OTTAVA is architected with four integrated robotic arms built into the operating table. This unified design is intended to offer surgeons more flexibility, space, and control during procedures, while also streamlining surgical workflows and reducing setup time.

With the first human surgeries performed under the system’s investigational device exemption (IDE) recently completed in Houston, Johnson & Johnson MedTech now aims to collect comprehensive data across a wide range of procedures. The goal is to support a future De Novo submission to the U.S. Food and Drug Administration (FDA), specifically targeting general surgical applications in the upper abdomen.

Where were the first OTTAVA surgeries performed and what procedures were involved?

The initial cases in the OTTAVA clinical trial were performed by Dr. Erik Wilson, Chief of Minimally Invasive and Elective General Surgery at UT Health Houston. The procedures took place at Memorial Hermann-Texas Medical Center, a major U.S. academic hospital. Dr. Wilson conducted Roux-en-Y gastric bypass surgeries, a complex weight-loss surgery that involves creating a small stomach pouch and rerouting the small intestine to support reduced food absorption.

These early surgeries are seen as a proving ground for the robotic system’s capabilities in managing multi-quadrant access—an essential requirement in many complex abdominal procedures. OTTAVA is specifically engineered to support such demanding surgical needs. By embedding the robotic arms within the surgical table, the system minimizes obstruction and improves ergonomics for the surgical team, including scrub nurses and anesthesiologists.

What makes OTTAVA different from other surgical robots on the market?

The OTTAVA robotic surgical system is Johnson & Johnson MedTech’s answer to the long-dominant da Vinci platform developed by Intuitive Surgical. OTTAVA’s standout feature is its unified architecture, with robotic arms that stow beneath the operating table. This contrasts with other systems that often require bulky external towers or positioning carts.

OTTAVA is designed to be adaptable for robotic, laparoscopic, hybrid, and open surgery approaches. This versatility is expected to appeal to hospitals looking for flexible surgical systems that do not compromise existing workflows. Additionally, OTTAVA is being developed with a view to integration into the Polyphonic digital ecosystem—Johnson & Johnson’s future vision for a connected, AI-enhanced operating room that combines data from surgical devices, imaging systems, and patient records.

The robotic system also benefits from Johnson & Johnson’s Ethicon brand, a trusted name in surgical instruments. The system’s instruments, powered by Ethicon technology, are tailored for precision, haptic feedback, and reliability across a range of soft-tissue procedures. This synergy between hardware and clinical-grade instrumentation could provide surgeons with enhanced tactile control and safety.

What clinical and regulatory steps remain for OTTAVA before commercialization?

Johnson & Johnson MedTech received IDE approval from the FDA in November 2024, enabling the commencement of clinical trials across multiple U.S. sites. These trials are designed to validate the system’s safety, efficacy, and performance across a variety of general surgery indications. Following data collection, the company plans to submit for De Novo classification—a regulatory pathway used for novel devices that have no existing predicate.

The current clinical study is focused on demonstrating the OTTAVA system’s capabilities in surgeries involving the upper abdomen. This includes not only gastric bypass but also procedures such as gastric sleeve surgery, small bowel resections, and hiatal hernia repairs. The system’s approval would likely target a multi-specialty indication, which is consistent with Johnson & Johnson MedTech’s strategy to position OTTAVA as a versatile surgical platform rather than a single-use or single-specialty solution.

Should the company receive De Novo authorization, it would signal FDA recognition that OTTAVA is both safe and effective for its proposed indications. This could then open the door to broader regulatory filings in international markets, including Europe and Asia, where robotic-assisted surgery is also experiencing accelerated growth.

How does OTTAVA fit into Johnson & Johnson’s broader MedTech strategy?

OTTAVA plays a strategic role in Johnson & Johnson MedTech’s long-term ambition to lead in digitally connected, minimally invasive surgical solutions. The company has been a major player in surgical innovation through brands such as Ethicon and DePuy Synthes, covering a broad portfolio that spans general surgery, orthopaedics, cardiovascular devices, and ophthalmology.

The global surgical robotics market, currently valued at over $8 billion, is expected to more than double by the end of the decade. Demand is being driven by an ageing population, increasing surgical volumes, and growing preference for minimally invasive procedures due to shorter hospital stays, lower complication rates, and faster recovery.

However, despite the overall growth in robotic surgery, challenges remain around cost-effectiveness, ease of use, and integration with hospital workflows. Johnson & Johnson MedTech is positioning OTTAVA as a solution that addresses these pain points. By reducing footprint size, improving interoperability, and delivering high-precision control, the company aims to make robotic surgery more accessible across a wider array of hospital types—including community hospitals and regional surgical centres.

How is Johnson & Johnson’s stock performing and what is investor sentiment around OTTAVA?

Johnson & Johnson (NYSE: JNJ) reported adjusted earnings per share of $2.77 and revenues of $21.9 billion for Q1 2025, beating Wall Street expectations. However, despite the strong earnings report, shares dipped roughly 1% in premarket trading on April 15, closing at $154.36. Year-to-date, the stock is up more than 6%, outperforming the broader market index, which has declined by about 8% over the same period.

The stock’s resilience is largely driven by the company’s diversified business model and defensive positioning amid global macroeconomic uncertainty. However, sentiment remains mixed. Investors remain wary due to legal headwinds, including ongoing talc-related litigation. A Texas court recently rejected the company’s attempt to resolve thousands of these cases via a subsidiary bankruptcy settlement.

Another risk to monitor is the impact of the Trump administration’s newly introduced pharmaceutical tariffs. While Johnson & Johnson executives have stated these costs are factored into the company’s forward guidance, policy volatility adds another layer of risk for long-term investors.

From a sentiment perspective, the outlook is currently neutral to cautiously optimistic. Analysts are holding their ratings steady, with a consensus leaning toward a “Hold” recommendation. Investors are advised to track both the progression of OTTAVA’s regulatory journey and the outcome of high-stakes litigation, which could influence future valuation.

What are the implications of OTTAVA’s progress for the surgical robotics industry?

OTTAVA’s advancement into human clinical trials represents a significant step not just for Johnson & Johnson MedTech but for the broader surgical robotics industry, which is seeing increased competition and innovation. In addition to legacy players such as Intuitive Surgical, new entrants like Medtronic with its Hugo system and Asensus Surgical with Senhance are challenging the status quo.

The trend is shifting toward systems that are modular, data-integrated, and adaptable across procedures. Hospitals are demanding more from their capital investments, and vendors must deliver technology that supports both improved clinical outcomes and operating room efficiency. OTTAVA’s unified design and future connectivity with digital health ecosystems could offer compelling value on both fronts.

If the system eventually gains FDA clearance and launches commercially, it could also intensify pricing and procurement competition. This may prompt broader changes in how hospitals evaluate robotic system ROI, with a focus on versatility, data integration, and staff training needs.

Why are investors and surgeons watching OTTAVA closely?

For investors, OTTAVA represents a long-awaited entry by Johnson & Johnson into a segment where the company has until now trailed competitors despite its extensive surgical device legacy. The system’s progress will be a critical metric in assessing the future competitiveness of Johnson & Johnson MedTech’s surgical business.

Surgeons and hospitals, on the other hand, are looking for systems that enhance surgical precision, reduce operating times, and offer seamless workflow integration. If OTTAVA delivers on these metrics, it may quickly gain traction as a preferred solution in both academic and private hospital settings.

With initial procedures now completed and data collection underway, the next 12–18 months will be crucial. As Johnson & Johnson prepares its De Novo submission, the medical device industry will be watching closely for signals of when OTTAVA may become available in the commercial market—and whether it can shift the balance in the evolving field of robotic-assisted surgery.