ROEN Surgical receives FDA clearance for Zamenix P
The U.S. Food and Drug Administration granted 510(k) clearance to ROEN Surgical’s Zamenix P robotic kidney-stone surgery system, opening a U.S. commercial pathway.
Evidence notes
- Zamenix is designed for flexible ureteroscopic treatment of kidney and ureteral stones using a patient-side robot and surgeon console.
- The platform remotely controls scope insertion, rotation and deflection together with laser and stone-basket instruments.
- ROEN described the clearance as the regulatory step enabling commercialization of the system in the United States.