Regulator
The FDA cleared da Vinci 5 for certain heart operations, such as mitral valve repair, done through small cuts between the ribs.
A regulator's decision · Company-reported · Sets da Vinci 5's stage
What the source says
“the U.S. Food and Drug Administration (FDA) has cleared the da Vinci 5 system for certain cardiac procedures”
What it means
da Vinci 5, from Intuitive, is at stage 5 of 5 on our ladder: regulator-cleared or mass market. This event is one of the milestones that placed it there. This line rests on the company's own announcement; no regulator, customer or independent report confirms it in our sources yet.
Human help: A surgeon in the operating room controls it; it doesn't operate on its own.
More on da Vinci 5
- Intuitive said it placed 315 da Vinci 5 systems in the third quarter of 2026, up from 240 a year earlier.
- Intuitive placed 246 da Vinci 5 systems with hospitals in the second quarter of 2026, up from 180 a year earlier.
- Intuitive started a Class 2 recall covering da Vinci X, Xi and da Vinci 5. A software error let instrument arms that failed a safety self-test stay in use.
- da Vinci 5 received the CE mark, which allows it to be sold in Europe, for adults and children.
- Intuitive began its full commercial rollout of da Vinci 5 in the US in 2025.
- Intuitive said da Vinci 5 would first go to a small number of US customers before a wider launch.