Sectra closes in on approval for digital mammography

Within months, Sectra plans to submit a premarketing agreement application to the FDA for its full-field digital mammography system, according to Torbjhorn Kronander, president of the Swedish mammography and IT firm.

Once the Sectra MicroDose Mammography system is approved for U.S. sale, the company plans to price it slightly above the industry standard, Kronander said. The reason is the high-sensitivity detector that promises to cut dose by one-half to one-third the amount necessary on current FFDM systems.

"Image quality is number one, but saving half or a third of the dose when you expose a huge population, as with mammography, will be a very strong argument for us," he said.

The detector achieves this level of performance by counting individual photons. It evolved from research done at CERN, the world's largest particle physics laboratory, aimed at studying quarks, the tiniest bits of matter, Kronander said.

Clinical research to support the pending PMA application was done at one site in the U.S., the Elizabeth Wende Breast Clinic in Rochester, NY. Discussions with the FDA led the company to conclude that no more clinical sites were needed.

The Sectra MicroDose Mammography system is already on the market in Europe, Australia, and New Zealand. The company upgraded the system with a stereotactic add-on shown this week at the European Congress of Radiology.

R&D engineers are also developing tomosynthesis and dual-energy capabilities for future upgrades, according to Kronander. The latter will allow contrast-enhanced vascular imaging of the breast.

How the system destined for the U.S., pending PMA approval, will be marketed and sold is still being discussed, he said. The company has not yet decided on whether to go with a direct sales force, distributors, or some combination.