FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Hologic’s Three-in-One Hysteroscope Cleared

Dec. 11, 2018
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Hologic’s Omni hysteroscope has received the FDA’s 510(k) clearance for use in treating abnormal bleeding in the uterus.

The thin, lighted tube, which is used to examine the cervix and inside of the uterus, can be used with Hologic’s hysteroscope fluid management system.

The scope can be used with different sheath options, allowing the physician to comfortably see and administer treatment without having to change out sheaths.

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