CIVCO Medical Solutions now can market its EX3 Stepper low-dose-rate (LDR) and high-dose-rate (HDR) ultrasound-guided brachytherapy system.
The developer of ultrasound and radiotherapy products received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for EX3 Stepper for prostate cancer detection and treatment.
LDR prostate brachytherapy involves internal radiotherapy in which small radioactive seeds are delivered through a needle and permanently placed in or near a tumor for treatment. HDR prostate brachytherapy is a similar internal treatment that involves the temporary placement of a tiny radioactive source directly into a tumor or near the targeted treatment area.
CIVCO said it has also received the CE Mark for EX3.
