Siemens gains FDA approval for digital mammography unit

Another vendor is ready to enter the market for digital mammography. Siemens Medical Solutions obtained FDA approval Aug. 20 for its Mammomat Novation DR full-field digital mammography system.

Siemens is the fourth vendor to offer such a product in the U.S. The others are Fischer Imaging, Hologic, and GE Healthcare, which pioneered flat-panel technology with the commercial release of its Senographe 2000D in 1999.

Last year, U.S. customers purchased 400 full-field digital mammography systems, according to consolidated industry estimates-about 40% of the total number of mammography systems sold that year in the country. Digital imaging may get the edge over film-based units this year, according to Don Alvarez, director of Siemens Women's Health, who predicts more than 500 digital units will be sold in the U.S. in 2004.

Several factors are driving this growth. Increased productivity is a key consideration. The Novation DR can easily handle 40 patient exams per day, Alvarez said. Sites in Europe, where the unit has been sold since January, have reported throughputs of up to 80 patients per day. Other factors include the increased reimbursement available for digital mammography and the need to take a radiology department totally digital.

Siemens' Novation will debut as a commercial product Sept. 20 at the Breast Imaging Conference in Monterey, CA. The company is also hatching plans for a road show to U.S. sites running up to the RSNA meeting in November.

The new product will be priced competitively with other full-field units, which go for around $450,000. But it will offer more than these competing models, according to Erica Rouleau, national sales director of Siemens Women's Health. The system supports screening and diagnostic mammography, as well as stereotactic biopsy. Competing systems do not.

"This is a Siemens exclusive," she said. "Competitors do not have the ability or FDA approval to do all the applications for a patient workup on one machine."

Novation DR is based on Siemens' flagship film-based mammography product, the Mammomat 3000 Nova. The major difference between the two is the film bucky versus the detector. Owners of film-based units will not likely receive field upgrades to digital, Alvarez said. Rather they will trade in their film-based units for brand new digital products.

The digital detector, which is supplied by Hologic, measures 24 x 29 cm-big enough to image most patient breast sizes in a single exposure. The detectors in some competing systems are substantially smaller.

"Not having sufficient coverage means more images have to be taken of the breast to get all the tissue," Rouleau said. "The images then have to be pieced together into a mosaic to be read. That is a huge productivity and workflow issue."

Having a large detector, however, can present a challenge for technologists trying to keep the breast centered in the x-ray beam. This challenge is addressed by a specially designed paddle.

Novation's two-panel dedicated workstation MammoReport Plus can display both current and prior mammograms-four images on each panel. Operators can then switch to different studies in less than a second. This fast response is impressive, considering that just one image may be composed of up to 26 MB.

MammoReport Plus will be upgradable to CAD software. Siemens is seeking FDA approval for the use of Novation DR with programs developed by R2 Technology and iCAD. Siemens last month purchased CADVision (SCAN 7/30/04), raising the possibility that custom-designed CAD will be developed for the Novation DR.

"Our integration CAD has yet to be fully defined, but we are working on it," Alvarez said.