FDA clears Hologic's Discovery DXA System for use in cardiovascular disease detection

By Lisa Kerner

Erie, Pa., May 4 - Hologic, Inc. said it has received clearance from the Food and Drug Administration to use information from its Discovery Dual Energy X-ray Absorptiometry 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 heart disease and stroke, according to a company news release.

The Discovery system measures bone density and vertebral fractures, primary diagnostic indicators of osteoporosis.

With the FDA clearance, doctors can now use the information from a standard low-dose, 10-second Instant Vertebral Assessment osteoporosis test to visualize the presence of AAC, which is associated with cardiovascular disease.

"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," said Douglas Kiel, an investigator in the Framingham Heart Study with the Harvard Medical School, in the release.

"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."

Located in Bedford, Mass., Hologic develops, manufactures and supplies diagnostic and medical imaging systems.

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