Versius

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 the newer Versius Plus through the 510(k) route, also for gallbladder removal (16 Dec 2025); The FDA granted Versius marketing authorization through the De Novo route, for gallbladder removal in adults 22 and older (14 Oct 2024).

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. All facts here come from CMR Surgical's own newsroom; we could not run further searches for independent coverage, the DEN number of the 2024 De Novo or the K-number of the 2025 clearance. CMR named no US hospital using Versius in the pages we opened.