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Panel Favors First Option, Proposes Study To Address Device Malfunctions

This article was originally published in The Gray Sheet

Executive Summary

CryoGen should conduct a premarket prospective study of the First Option uterine cryoablation therapy to validate changes made in response to reported device malfunctions, FDA's Obstetrics and Gynecology Devices Panel agreed Jan. 29 in recommending an expanded claim for endometrial ablation.

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