Intuitive Surgical (NASDAQ:ISRG) announced Thursday it has received FDA 510(k) clearance for its advanced da Vinci 5 multiport surgical robotics system, marking a significant step forward less than two months after revealing its submission for clearance and unveiling the system's name.
Building upon its predecessor, the da Vinci Xi—which has been utilized in over seven million procedures globally—the new system introduces over 150 improvements.
These enhancements include heightened precision, a cutting-edge 3D display with superior image processing, and pioneering force-sensing technology.
Moreover, the da Vinci 5 system brings advancements aimed at bolstering surgeon independence and optimizing surgical workflows.
“Early da Vinci 5 perspectives argue that the new system is a powerful and compelling next-generation robotic-system with significantly expanded features, instruments, and capabilities,” said Stifel analysts after Intuitive received the clearance.
“As we await more detailed commentary on Monday, we're inclined to see this new system as driving meaningful ISRG growth for years to come,” they added.
Citi Research analysts commented:
“For the physicians and patients this should be well received, for investors this too should be welcomed as the company begins a limited launch with existing customers involved in its development as it generates more data before full commercial launch.”