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FemRx' Opera Star cleared for US marketing

This article was originally published in Clinica

Executive Summary

Gynaecology specialist FemRx has received 510(k) clearance for its minimally invasive alternative to hysterectomy, the Opera Star system. The Out-Patient Endometrial Resection/Ablation device treats abnormal uterine bleeding in most patients without the need for an incision (see Clinica No 696, p 10). The system consists of a Specialised Tissue Aspirating Resectoscope which enables gynaecological surgeons to resect and ablate the endometrial lining and remove fibroids while continuously aspirating tissue for pathological evaluation.

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