Hologic wins FDA nod for Affirm biopsy system launches in US

Hologic (NSDQ:HOLX) said today it won FDA 510(k) clearance for its Affirm prone biopsy system and launched the platform in the U.S.

The Affirm biopsy system is the 1st prone biopsy system to offer both 2D and 3D imaging-guided breast biopsies, the Marlborough, Mass.-based company claims. The device is designed to allow radiologists to target lesions found during 3D mammography exams.

“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. 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. 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,” breast and skeletal health solutions division prez Pete Valenti said in a prepared statement.

The Affirm system allows patients to lay prone to provide 360-degree access to lesions using its C-arm, with varied approach angles and minimal movement required for patients, Hologic said.

“Until now, we’ve been struggling to handle complex biopsies for subtle lesions or faint calcifications that we are only able to identify using 3D mammography exams. As an early testing site for the Affirm prone biopsy system, we’ve had the opportunity to perform many biopsies using this technology, and are pleased to report that this new biopsy table has helped to solve our challenges. We are able to visualize more tissue and have access to challenging lesion locations, and the procedures are very fast,” Dr. Alejandro Tejerina of Madrid, Spain’s Centro Patologia de la Mama said in prepared remarks.

Hologic said the system has already won CE Mark approval in the European Union and it has begun to install the system at sites in Europe.

In February, Hologic said a study of women screened for breast cancer over multiple years using its Genius 3D mammography system showed a significant drop in recalls.

The findings, which were published in an advance print of the journalJAMA Oncology this month, indicated that the use of Marlborough, Mass.-based Hologic’s 3D mammography unit resulted in less call backs, more cancer cases found in recalled patients and fewer cancers diagnosed between regular screenings.

In January, Hologic saw shares dip slightly after posting its fiscal year 2016 Q1 earnings, beating the street across all points and adjusting earnings per share guidance up.

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