FDA clears VivaMed's next-generation TUNA (transurethral needle ablation) system:
This article was originally published in Clinica
VivaMed has received US FDA 510(k) clearance to market its next-generation Precision Office transurethral needle ablation (TUNA) system for the treatment of benign prostatic hyperplasia. The radiofrequency ablation-based system incorporates the Fremont, California company's Precise Reassurance Technology that monitors intra-prostatic pressure during the treatment, which takes about 20 minutes compared with 30 minutes using its previous device, the ProVu, said VivaMed.
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