Technology | August 14, 2013

FDA Clears Hologic's Single Energy Femur Exam to Visualize Atypical Femur Fractures

Exam is on a dual energy X-ray platform

August 14, 2013 — Hologic Inc. received U.S. Food and Drug Administration (FDA) clearance for the Single Energy (SE) Femur Exam on a dual energy X-ray absorptiometry (DXA) platform for the assessment of features associated with atypical femur fractures (AFF). This capability assists clinicians in their assessment of potential AFF in patients who have been on anti-resorptive treatments such as bisphosphonates.

The new assessment option will be offered exclusively on Hologic's Horizon DXA platform, a soon to be commercialized product line of bone densitometers. This quick 15-second SE Femur Exam is designed to produce a high-resolution image of the entire femur with a very low effective radiation dose. An AFF assessment can be conveniently performed at the time of a hip bone density scan with little or no patient repositioning and a minimal increase in exam time.

“An atypical femur fracture is an extremely debilitating fracture, in many instances much worse than a normal osteoporosis-related hip fracture. While these fractures are uncommon, the morbidity associated with them is significant,” said John Jenkins, Hologic Vice President of Marketing for Specialty Imaging Products. “By including a convenient way for the physician to assess possible developing AFFs, early medical intervention may avoid the significant morbidity of a complete atypical femur fracture."

For more information: www.hologic.com

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