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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Simultaneous FDA approval of BEI Medical Systems' Hydro ThermAblator and CryoGen's HerOption devices for excessive uterine bleeding clears the way for introduction of both systems at the American College of Obstetricians and Gynecologists meeting April 30 in Chicago, the firms say.
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