Edap Technomed Prostatron is first microwave system approved by FDA for BPH.
This article was originally published in The Gray Sheet
Executive Summary
EDAP TECHNOMED PROSTATRON POSTMARKET STUDY NEARING COMPLETION, according to the Cambridge, Massachusetts firm. Edap says it is in the final stages of collecting follow-up data on 100 patients treated with the microwave-based system for benign prostatic hyperplasia (BPH). FDA conditioned its May 3 approval of the device's premarket approval application on collection of the postmarket data.