Women's imaging vendor Hologic of Bedford, MA, has received CE Mark approval for its Celero vacuum-assisted spring-loaded core biopsy device.
The company is targeting Celero for the ultrasound market and also received CE Mark approval for the CeleroMark and CeleroMark-2S biopsy site identifiers, as well as the Celero Intro-12 introducer, clearing the way for sales in the European Union and all countries that recognize the CE Mark.
Hologic also is registering Celero in Latin and South America, the Middle East, and Asia. Celero received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in April 2007.
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