Regulator
The FDA cleared the AquaBeam System through the De Novo route (DEN170024) to remove prostate tissue for men with an enlarged prostate.
A regulator's decision · Sets AquaBeam and HYDROS (Aquablation)'s stage
What the source says
“Procept BioRobotics said today that it won de novo clearance from the FDA for its Aquabeam device”
What it means
AquaBeam and HYDROS (Aquablation), from PROCEPT BioRobotics, 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: Our sources report it working without human help.
More on AquaBeam and HYDROS (Aquablation)
- In April to June 2026, PROCEPT delivered 65 HYDROS robots in the US, 14 of them replacing older systems.
- Revenue for April to June 2026 was $94.5 million, up 19% on a year earlier. The company still lost $26.9 million in the quarter.
- By August 2024, PROCEPT said more than 400 of its robots were installed in US hospitals, after more than 50,000 procedures.
- 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.
- The FDA used a 181-patient study called WATER to decide on the clearance.