Trade Resources Industry Views Hologic Received The US FDA for Se Femur Exam

Hologic Received The US FDA for Se Femur Exam

Hologic has received the US Food and Drug Administration (FDA) clearance for its Single Energy (SE) femur exam, designed to visualize features associated with AFFs quickly and conveniently at the time of osteoporosis assessment.

The quick 15-second SE femur exam on a dual energy x-ray absorptiometry (DXA) platform will produce a high resolution image of the entire femur with a very low effective radiation dose.

This new 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.

Hologic vice president of marketing for specialty imaging products John Jenkins noted the company developed its SE femur exam in an effort to provide clinicians with the critical information needed to effectively manage patient care and improve fracture-related outcomes.

"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," Jenkins added.

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.

 

Source: http://healthcareit.medicaldevices-business-review.com/news/hologic-obtains-fda-clearance-for-single-energy-femur-exam-to-visualize-affs-020813
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Hologic Obtains FDA Clearance for Single Energy Femur Exam to Visualize AFFs