FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Hologic’s Three-in-One Hysteroscope Gains CE Mark

March 5, 2019
A A

Hologic received the CE Mark for its Omni three-in-one hysteroscope, a modular scope used in both diagnostic and therapeutic procedures to diagnose and treat causes of abnormal bleeding in the uterus.

The device, which previously received the FDA’s 510(k) clearance, is a thin lighted tube that is used to examine the cervix and inside of the uterus and works with the company’s hysteroscope fluid management system.

The scope comes with different sheath options, enabling the physician to perform treatments without changing sheaths.

View today's stories