Dive Brief
Intuitive Surgical said Thursday it received 510(k) clearance from the Food and Drug Administration for a fifth-generation robotic surgery system intended to help the company keep its dominant market share in the face of looming competition.

The da Vinci 5 system incorporates features that surgeons have long sought, such as feedback that simulates the feel of the patient’s body tissue, a smaller physical footprint in the operating room, and better console ergonomics.

The improvements “can help drive incremental demand for the system and raise the bar for competition in the future,” William Blair analyst Brandon Vazquez said Friday in a note to clients.

Dive Insight
Intuitive is preparing for competitive challenges from Medtronic and Johnson & Johnson, as well as a wave of startups hoping to vie for a piece of the growing market.

The robot maker, which saw its procedure volumes increase by 21% in the fourth quarter, revealed in January that it submitted an application to the FDA for the new system, but provided few details about its features at the time.

The new robot boasts tremor controls to improve surgical precision, higher-quality imaging, greater computing power and data capabilities, and other functions to streamline the healthcare team’s workflow. Intuitive believes the system’s enhancements should lead to better patient outcomes, save time and ultimately lower the cost of care.

The workflow improvements “can potentially reduce procedure times and the cost of each procedure, which can incentivize hospitals to convert additional surgical volumes to da Vinci,” William Blair’s Vazquez wrote.

Intuitive said the new robot has been in development for more than a decade. The company will initially make the product available to a small number of U.S. customers that collaborated in the development process and those with mature robotic surgery programs.

Truist analyst Richard Newitter noted that some functions will be released over time, including “software updates that the company will likely launch over a period of years to enhance the system and functionality of the platform as time goes on.”

Citi Research analyst Joanne Wuensch said the FDA’s approval of the da Vinci 5 system marks a new phase in robotic surgery.

“For the physicians and patients this should be well received, for investors this too should be welcomed,” Wuensch wrote to clients.

Source:
https://www.medtechdive.com/news/intuitive-new-da-vinci-robot-fda-clearance/710436/