Hologic Receives FDA Clearance For DEXA Body Values
Hologic, Inc. yesterday announced that it has received U.S. Food and Drug Administration (FDA) clearance to incorporate the U.S. National Health and Nutrition Examination Survey (NHANES) Whole Body Reference Data into its Discovery dual x-ray absorptiometry (DXA) systems. These body composition values are useful to healthcare professionals in their management of diseases and conditions when the disease or condition itself, or its treatment, can affect the relative amounts of fat and lean tissue, according to the company. The Hologic Advanced Body Composition assessment package is designed to provide quick, low-dose X-ray exams, with whole body composition scans taking as little as three minutes, the vendor says. The assessment package includes color images that display the distribution of fat, lean tissue, and bone. John Jenkins, vice president and general manager of the company’s Hologic Skeletal Health business unit, says the FDA clearance opens up a new market for the Hologic Discovery whole body DXA systems which, up to now, have primarily been used to measure osteoporosis in women after they reach menopause. Some of the diseases and conditions for which body composition values are useful include chronic renal failure, anorexia nervosa, obesity, AIDS/HlV, and cystic fibrosis, he notes.