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Intuitive Surgical Seeks FDA Clearance for Da Vinci 5 Surgical Robot

by Pieter Werner

Intuitive Surgical has recently submitted a request for FDA 510(k) clearance for its next-generation multiport surgical robot, the da Vinci 5. This new addition is set to join Intuitive’s existing portfolio of robotic surgical systems, which includes the multiport X and Xi systems and the single-port SP, as well as the Ion platform for minimally invasive biopsy in the lung.

Gary Guthart, CEO of Intuitive Surgical, discussed the submission and the ongoing process with the FDA during an earnings call with analysts. He expressed hope for a 2024 launch of the da Vinci 5, acknowledging that the final clearance timeline depends on the FDA.

The company’s stock experienced fluctuations following the announcement, with a more than 6% increase to $395 per share in after-hours trading, followed by a decline of more than 2% the next day, settling at around $364 per share. This occurred against a backdrop of a slight downturn in the MassDevice’s MedTech 100 Index.

The advancement of the da Vinci 5 has been a topic of interest, especially considering the previous silence from Intuitive officials regarding the timing of its launch. This development comes after the company’s stock experienced a temporary decline when Guthart previously mentioned that there would be no new multiport system launch in 2023.

Intuitive has completed a comprehensive multicenter IDE trial for the da Vinci 5, with patient accrual concluding in May 2023 and the 510(k) clearance submission occurring in August 2023. The company is currently addressing questions from the FDA, which Guthart described as typical for such a process.

In preparation for the launch of da Vinci 5, Intuitive is also engaging with regulators in Japan and South Korea. Jamie Samath, CFO of Intuitive Surgical, outlined the company’s manufacturing plans for the new system. Production of the X system has already moved to the company’s East Coast hub near Atlanta, with Xi system production set to follow this year. Over the next 18 months, new manufacturing facilities will be opened in California for the da Vinci 5 and Ion, and production lines for Ion and SP will be transferred to Mexicali, Mexico.

Further details about the features and benefits of the da Vinci 5 are expected to be revealed after FDA clearance is received. According to Guthart, the new system has undergone numerous design changes based on feedback from surgeons and care teams, featuring significantly enhanced processing power.

In addition to the da Vinci 5 news, Intuitive Surgical reported that the da Vinci SP has received a CE mark in the European Union, expanding the company’s market reach. The fourth-quarter results for 2023 indicated a 17% increase in revenue year-over-year, reaching $1.93 billion, with a net income of $606 million.

Analysts Brandon Vazquez and Justin Lin at William Blair commented positively on the prospects for 2024, expecting meaningful procedure growth from the da Vinci 5 starting in mid-2025. They also noted that the new system would reinforce Intuitive’s position in the competitive landscape of robotic surgery.

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