FDA clears Philips' full-field digital mammo system

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Royal Philips Electronics has received 510(k) clearance from the FDA for its MicroDose SI system, a full-field digital mammography (FFDM) system with the capability to enable future Single-Shot Spectral Imaging applications (which is not available in North America).

Philips is working on future software applications like Spectral Breast Density Measurement, which will build upon the MicroDose SI technology. Spectral Breast Density Measurement also is not available in North America.

As in existing Philips MicroDose systems, the MicroDose SI uses digital photon-counting technology. Philips has upgraded this technology with Single-Shot Spectral Imaging, which is built upon the fact that breast density is subject to different tissue types and materials that absorb x-rays at various energies, according to the company.