Intuitive wins FDA clearances for cardiac procedures on da Vinci 5

Intuitive Surgical  (Nasdaq: ISRG)+ has received FDA clearance for “several cardiac procedures,” CEO Dave Rosa said while announcing the surgical robotics company’s latest financial and operating results on Jan. 22.

Those clearances cover Intuitive’s latest-generation da Vinci 5 (DV5) using non-Force Feedback instruments, he said. Intuitive did not name the specific procedures at the time, and they do not appear to be publicly available in the FDA’s 510(k) clearance database.

But on Jan. 26, Intuitive said the new cardiac clearances covered: mitral valve repair; internal mammary artery (IMA) mobilization for cardiac revascularization; patent foramen ovale closure; atrial septal defect repair; left atrial appendage closure/occlusion; atrial myxoma excision; mitral valve replacement; tricuspid valve repair; and epicardial pacing lead placement.

“Given the complexity of minimally invasive cardiac surgery, we are planning a measured roll-out to support training, education and adoption,” Rosa said. “We believe deeply that patients requiring cardiac surgery can benefit from a minimally invasive approach with da Vinci and look forward to actively supporting our customers through these procedures.”

“We’ve been supporting cardiac surgery for decades and have a good understanding of what cardiac programs need to do to be successful and have a great patient outcomes, and so there are some foundational aspects that we’re working on today,” he later continued. “Those include clearances on the platform —on DV5 — in certain geographies. We just received the U.S. clearance. We’re working through approval in Europe and several other countries. Part of those indications as well will include Force Feedback instruments.”

Surgeons used the company’s da Vinci Si and Xi robotics systems for about 17,000 cardiac procedures worldwide in 2025, Intuitive CFO Jamie Samath said.

“That business has been growing for multiples of years but obviously from a small base,” he said. “… When we look at where cardiac is cleared for da Vinci 5, which currently is now the U.S. and Korea  we think the opportunities from a da Vinci 5 perspective or a robotic perspective is about 160,000 procedures per year. Obviously, that has the opportunity to expand if and as we add additional geographies.”

The initial U.S. clearance “incorporates Intuitive’s entire portfolio of non-Force Feedback instruments and has value today for cardiac procedures,” Rosa said. Intuitive will pursue cardiac clearances for its Force Feedback portfolio as well, he said.

“Cardiac surgery is a wide variety of procedures with a wide variety of tasks, and we do think that Force Feedback can have some benefit in certain parts of certain procedures,” he said.

The company is also developing training, Rosa said.

“It’s a unique pathway to learn the cardiac robotic surgery business, if you will, for minimally invasive approaches with da Vinci and so we’re investing there,” he said. “We are developing cardiac-specific instrumentation, including Force Feedback, some accessories and tuning some of the digital tools we have. Those will be multi-year efforts to bring all of those to the market.”

In April 2025, Darla Hutton announced her new role as Intuitive’s global VP of cardiac surgery.

“Da Vinci 5 marks the beginning of a global initiative to help transform cardiac care,” she said in a news release announcing the cardiac clearances. “By combining 30 years of meaningful innovation, structured team-based training programs and a service model built on reliability and safety, we believe we can enable cardiac teams to adopt robotic-assisted surgery in a consistent, scalable and sustainable way.”

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Intuitive’s financial and operating results

Intuitive released preliminary financial results earlier this month and today offered new details and forecasts for the year ahead.

The company reported net income of $794.8 million for the fourth quarter (ended Dec. 31, 2025), or $2.21 per diluted share. Adjusted EPS was $2.53, 26¢ ahead of the Wall Street consensus of $2.27 EPS.

ISRG shares were up more than 2% to $538.30 apiece in after-hours trading on the initial announcement.

This article was first published on Jan. 22, 2026, and updated on Jan. 26 with new details about the cardiac procedures.