FDA nod for Hologic breast biopsy system that offers 3-D image guidance

Hologic ($HOLX) said the FDA cleared its Affirm prone biopsy system, which it said is the first dedicated prone system to offer both 2-D and 3-D imaging-guided breast biopsies. The company said that it has already launched the system, which is expected to enable radiologists to better target lesions found during 3-D mammography exams and other types of screening. "The launch of our Affirm prone biopsy system is the most significant advancement in prone biopsy technology since we introduced the first system more than 20 years ago," said Pete Valenti, Hologic's division president for breast and skeletal health solutions, in a statement. "We identified a need for a minimally invasive, stereotactic breast biopsy technology that marries the advances in 3-D mammography exams with the prone positioning many doctors prefer and are excited to bring this new generation prone biopsy system to market." More