FDA Approves Intuitive Surgical's Da Vinci 5 Surgical System, Analyst Outlines Sees Long-Term Growth Potential

The FDA provided 510(k) clearance on Thursday to Intuitive Surgical, Inc.’s ISRG Da Vinci 5, the company’s next-generation multiport robotic system.

Surgeons and care teams worldwide have used the Da Vinci 5 surgical system in over 7 million procedures. 

The company placed 415 Da Vinci surgical systems in the fourth quarter of 2023, compared with 369 systems in the fourth quarter of 2022.

The system includes more than 150 enhancements, including:

• Da Vinci 5’s Force Feedback technology and optional instruments enable the system to measure and surgeons to feel subtle forces exerted on tissue during surgery. In preclinical trials with surgeons at all experience levels, Force Feedback demonstrated up to 43% less force exerted on tissue, which may translate to less trauma on tissue. 
• Improved accuracy and precision with new surgeon controllers and powerful vibration and tremor controls.
• Da Vinci 5 has over 10,000 times the computing power and improved surgeon comfort.

Da Vinci 5 will initially be available to a small number of customers in the U.S. who collaborated with Intuitive during the development period and those with mature robotic surgery programs. 

Intuitive will work with surgeons at these initial sites to generate additional data on the system’s use before a wider commercial introduction.

William Blair’s analysis of the Da Vinci 5 indicates optimism for its long-term growth potential, pending key details like pricing and launch timing. 

The November 2023 survey highlights the Da Vinci 5 incorporates three of the top four requested features by bariatric surgeons, including reduced size, haptic feedback (Force Feedback), and improved console ergonomics. 

These enhancements are expected to boost demand and set higher standards for competitors. 

Additionally, William Blair stated the introduction of significantly more powerful computing power, 10,000 times greater, may not be fully appreciated by investors immediately but lays the foundation for future advancements in AI and advanced imaging technologies.

The analyst reiterated the Outperform rating.

ISRG Price Action: ISRG shares closed are up 2.09% at $392.35 on publication Friday.

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Photo: Courtesy of Intuitive Surgical