Regulator
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.
A regulator's decision · Company-reported · Sets AquaBeam and HYDROS (Aquablation)'s stage
What the source says
“today announced FDA 510(k) clearance of its next-generation platform, the HYDROS™ Robotic System.”
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. This line rests on the company's own announcement; no regulator, customer or independent report confirms it in our sources yet.
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.
- The FDA cleared the AquaBeam System through the De Novo route (DEN170024) to remove prostate tissue for men with an enlarged prostate.
- The FDA used a 181-patient study called WATER to decide on the clearance.