FDA clearance for Hologic Affirm prone biopsy system

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Hologic announced today that its Affirm prone biopsy system has received clearance from the FDA and is now commercially available in the United States.

The Marlborough, Mass.-based medical imaging company’s Affirm system is the first of its kind to offer both 2D and 3D imaging-guided breast biopsies, according to a press release.

"At Hologic, we challenge ourselves to advance medical technology so that healthcare professionals and patients can benefit from innovative solutions that significantly improve outcomes and patient experience, while also creating a powerful economic model for our customers," said Hologic’s Pete Valenti. "We identified a need for a minimally invasive, stereotactic breast biopsy technology that marries the advances in 3D mammography exams with the prone positioning many doctors prefer, and are excited to bring this new generation prone biopsy system to market."

The Affirm system boasts a larger field of view than other dedicated prone biopsy systems and allows radiologists to better target lesions found during 3D mammography exams, the company said.

The system is now available for order in the U.S.

Read the full announcement.