FDA clears Hologic specimen x-ray

Women's imaging firm Hologic has received clearance from the U.S. Food and Drug Administration (FDA) for a new specimen radiography system.

Called Trident, the cart-mounted system uses Hologic's selenium-based digital detector technology with a 12 x 14-cm active imaging area to produce images for rapid verification of tissue specimens such as breast biopsy samples. The system is designed to free up a facility's primary mammography system, which some sites use for specimen biopsy if they don't have a dedicated unit.

Trident is designed for use in the operating room, where breast tissue is surgically excised, and in biopsy suites where minimally invasive, stereotactic, or ultrasound breast biopsies are performed, the company said.