AquaBeam and HYDROS (Aquablation)

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: PROCEPT said the FDA cleared HYDROS, its next-generation robot, through the 510(k) route. HYDROS adds AI help for planning the cut on ultrasound (21 Aug 2024); The FDA cleared the AquaBeam System through the De Novo route (DEN170024) to remove prostate tissue for men with an enlarged prostate (21 Dec 2017).

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. Install base table in the Q2 2026 filing shows 816 US systems at 30 June 2026 (not quoted as a sentence). Earlier reports of an early-2018 US launch were not checked separately.