Da Vinci 5 vs Hugo vs Ottava: What Their 2026 FDA Clearances Mean
Updated: Sep 21
Da Vinci 5, Medtronic Hugo and Johnson & Johnson Ottava entered 2026 with different FDA clearances, covering cardiac surgery, urology and upper-abdominal general surgery.
Da Vinci 5: Cardiac
On January 26, 2026, the FDA cleared da Vinci 5 for nine cardiac procedures, including mitral valve repair, tricuspid valve repair, and left atrial appendage closure.
Cardiac surgery was the first specialty ever cleared on the original da Vinci system, back in 2002.
Intuitive stepped back from it for years. Early-generation hardware couldn't fully support it, and the training infrastructure wasn't there yet.
More than 140,000 robotic-assisted cardiac procedures have been performed on da Vinci systems since, across 51 countries.
The new clearance covers non-Force Feedback instruments only. Force Feedback for cardiac is still in development.
Intuitive says da Vinci 5 carries more than 10,000 times the computing power of da Vinci Xi, and its smart instruments capture over 1,000 data points per second.
Source: Intuitive Surgical
Hugo: Urology
On December 3, 2025, the FDA cleared Medtronic's Hugo RAS system for urologic procedures — its first US clearance of any kind.
The clearance covers prostatectomy, nephrectomy, and cystectomy: procedures that account for roughly 230,000 US surgeries a year.
It rested on the Expand URO trial, the largest US study completed for multi-port robotic urologic surgery, which met its primary safety and effectiveness endpoints.
Hugo had already been used in tens of thousands of procedures outside the US, across more than 30 countries. December 2025 was its US market entry.
The first US case followed on February 17, 2026, a robot-assisted prostatectomy at Cleveland Clinic.
Source: Medtronic
Ottava: Upper-Abdominal General Surgery
On July 22, 2026, the FDA authorized Ottava De Novo — a pathway reserved for genuinely novel device types with no legally marketed predicate.
The clearance covers ten procedures in general surgery, including gastric bypass, gastrectomy, cholecystectomy, and splenectomy.
Ottava is J&J's first FDA-authorized soft-tissue robot, and the only one of the three built with its arms integrated directly into the operating table rather than mounted on a separate cart.
J&J says that architecture lets it occupy 30–50% less floor space than traditional boom- and cart-mounted systems, based on the company's own September 2025 evaluation.
The company plans a limited initial rollout with select US customers before expanding further.
Source: Johnson & Johnson
Three Wedges, Not Three Rivals
For twenty years, competing in soft-tissue robotics meant competing for the same procedures.
That's not what's happening here.
Da Vinci 5 re-entered a specialty it once walked away from. Hugo picked the highest-volume specialty open to a new entrant. Ottava skipped a head-to-head fight and built a different kind of robot.
Da Vinci 5 is returning to cardiac. Hugo is entering through urology. Ottava is starting somewhere neither of them is.
None of the three claims autonomy. All three remain surgeon-controlled platforms, cleared for specific procedures rather than general use.
The Clearances at a Glance
Robot | Specialty | Clearance Date | FDA Pathway |
da Vinci 5 | Cardiac surgery (9 procedures) | January 26, 2026 | FDA 510(k) |
Hugo | Urology (prostatectomy, nephrectomy, cystectomy) | December 3, 2025 | FDA 510(k) |
Ottava | Upper-abdominal general surgery (10 procedures) | July 22, 2026 | FDA De Novo |
