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DOTmed caught up with Hologic director of marketing, Jim Culley, Ph.D., at the 2009 AHRA Annual Meeting and Exhibition to talk about emerging technologies and the company's role in women's health.

As of Aug. 1, there were 8,711 certified sites across the country providing mammography services according to the FDA's monthly Mammography Quality Standards Act (MQSA) scorecard. About 54 percent of the sites had gone digital -- up from 40 percent a year ago, said Culley.



"We seem to be doing a lot of things right," noted Culley. "U.S. industry shipment data shows that Hologic enjoyed over 65 percent of all digital mammography (DR and CR) sales in the first half of 2009 -- a new record for us. NEMA (National Electrical Manufacturers Association) data show that analog mammography shipments have almost disappeared. Less than 5 percent of the mammography systems sold in the U.S. 2008 were analog."

In the past few months, Hologic has introduced a number of new products to the company's portfolio of women's health products, including the automated Quantra breast density assessment software.

"It creates an internal 3D model of the breast from which it derives estimates of the fibro glandular tissue volume and total breast volume; volumetric breast density is the ratio of these values," explained Culley. "Using the Quantra tool to provide numeric values for each breast may aid radiologists in the assessment of breast tissue composition without the subjectivity of human interpretation."

The company recently released DigitalNow HD, the only FDA-cleared application for processing and comparing digitized screen-film mammograms.

Hologic also just introduced three new Selenia digital mammography products in the U.S. including their Selenia Dimensions 2D system, and the Selenia Dimensions 2D FFDM, which can be configured for 3D breast imaging, also known as tomosynthesis, when and if the 3-D technology is approved by the FDA.

"Digital Breast tomosynthesis is a three-dimensional imaging technology that involves the acquisition of a series of low-dose images at different angles across a stationary compressed breast," explained Culley. "The individual images are then reconstructed into a series of thin high-resolution slices that can be displayed individually or in a dynamic cine mode. This separation of tissue into virtual layers helps the physician clearly see features which might be obscured in a traditional two-dimensional mammogram."

Hologic breast tomosynthesis showed distinct improvement in clinical accuracy according to clinical trials, which also showed "dramatic gains in specificity -- the confidence to rule out cancer without recalling the patient for further study," stated Culley.

Continue reading Hologic Talks Digital Mammography, Tomosynthesis and Women's Health...

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