Hugo

1. 5

   Regulator-cleared or mass marketThis robot

   A regulator has cleared it where approval applies: FDA clearance or approval for a medical robot, a permit to run with no one aboard for a self-driving vehicle, or an FAA approval for routine drone flights. Or: Widely sold: sales in the hundreds of thousands, or a product category you can buy in ordinary shops.

   Placed by: The FDA cleared a Medtronic vessel-sealing instrument for use with Hugo. Medtronic expects Hugo to pass 50,000 completed operations this financial year (17 Sept 2026); The FDA cleared Hugo for soft-tissue urology operations, such as on the prostate, kidney and bladder (3 Dec 2025).

2. 4

   Paying customers

   Delivered to customers who pay for it, beyond a trial, or a paid service the public can use.

3. 3

   Pilot

   Working with a named customer in a real setting, as a trial.

4. 2

   Pre-orders

   Orders, reservations or deposits taken, with nothing delivered yet.

5. 1

   Demo only

   Shown in videos, staged events or a factory, with no units working for customers.

What we couldn't confirm. As of a 17 Sept 2026 MedTech Dive report, no FDA decision on the general surgery and gynecology filings had been reported. We did not find the 510(k) number for the December 2025 clearance, or any Hugo recall, in sources we opened. Medtronic is based in Ireland, with main operations in Minnesota, US.