Hologic nets CE Mark for breast biopsy device

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Hologic, a developer and supplier of medical imaging systems and surgical products for women’s healthcare needs, has received CE Mark approval for its Celero vacuum-assisted, spring loaded core biopsy device.

Celero is an FDA-approved vacuum-assisted core biopsy device for the breast ultrasound market. The Bedford, Mass.-based company also has received CE Mark approval for the CeleroMark and CeleroMark-2S biopsy site identifiers, as well as the Celero Intro-12 introducer.  

With the option of firing inside or outside the breast, Hologic said its Celero device is designed to access lesions in the axilla, near the chest wall, near implants or behind the nipple. The design of the handheld Celero device and its highly echogenic needle provides penetration to lesions, while reducing deflection and offering a visible aperture location for target verification under ultrasound imaging prior to tissue acquisition.

Hologic said it is further registering its Celero device in markets in Latin and South America, the Middle East and Asia.