Hologic Inc. received clearance by the U.S. Food and Drug Administration for its Single Energy Femur Exam on its x-ray system
The Bedford, Mass.-based manufacturer and supplier of diagnostics products, medical imaging systems and surgical products received FDA clearance of its SE Femur Exam that will be offered on its Horizon DXA platform, a line of bone densitometers soon to be commercialized, the company said Thursday.
The less than 20-second exam was developed to produce a high-resolutions image of the entire femur with a low radiation dose, according to the company.
According to Hologic’s Vice President of Marketing John Jenkins, an atypical femur fracture (AFF) is an extremely debilitating and in many cases worse than a normal osteoporosis-related hip fracture.
Recent studies have linked long-term use of biophosphates therapy (used by patients suffering from osteoporosis) with increased risk of atypical femur fractures, which occur without trauma or with only minimal trauma.
“We developed our Single Energy Femur Exam in an effort to provide clinicians with the critical information needed to effectively manage patient care and improve fracture-related outcomes,” Jenkins said.