Regulator
The FDA cleared Hugo for soft-tissue urology operations, such as on the prostate, kidney and bladder.
A regulator's decision · Sets Hugo's stage
What the source says
“The FDA clearance allows Medtronic to market its system for use in soft-tissue urologic surgical procedures.”
What it means
Hugo, from Medtronic, 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.
Human help: The maker hasn't said whether people help it remotely.
More on Hugo
- The FDA cleared a Medtronic vessel-sealing instrument for use with Hugo. Medtronic expects Hugo to pass 50,000 completed operations this financial year.
- Medtronic agreed to sell Cornerstone Robotics' Sentire surgical robot alongside Hugo in some markets outside the US, as part of a deal of about $700 million.
- Medtronic asked the FDA to clear Hugo for general surgery, including hernia repair, and for gynecologic surgery.
- The first US operation with Hugo, a prostate removal, was done at Cleveland Clinic in February 2026.
- Medtronic executives said supply chain and manufacturing problems slowed Hugo's rollout after the pandemic.
- Hugo received the CE mark, which allows it to be sold in Europe.