FDA clears Hologic Discovery for detecting cardiovascular disease

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Hologic Inc. today announced that it has received FDA clearance to use information from the Hologic Discovery Dual Energy X-ray Absorptiometry (DXA) system as a predictor of coronary heart disease, stroke, and other forms of cardiovascular disease. The new indication, visualization of abdominal aortic calcification (AAC), targets the No. 1 cause of morbidity and mortality in older women and men – heart disease and stroke, according to a release.

Discovery works by measuring the two primary diagnostic indicators of osteoporosis — bone mineral density and vertebral fractures. The FDA’s clearance means that doctors can use the information from a standard low dose, 10-second Instant Vertebral Assessment (IVA) osteoporosis test, to visualize the presence of AAC, which is associated with cardiovascular disease.

“Abdominal aortic calcification is strongly associated with cardiovascular disease including heart attacks and strokes,” said Douglas Kiel, MD MPH, associate professor of Medicine, Harvard Medical School, director of Medical Research at Hebrew SeniorLife, and an investigator in the Framingham Heart Study. “These abdominal aortic calcifications can be seen in IVA scans, and if present, have significant implication for the care of the patient. AAC is particularly valuable since it contributes independently of traditional clinical risk factors such as cholesterol, blood pressure, diabetes and age to the prediction of heart attack risk. Additionally, AAC seems to be a particularly strong risk factor in postmenopausal women, which is the population that is also in greatest need of osteoporosis assessment.”