FDA Clears Philips’ MicroDose SI Mammo System

Philips has received FDA 510(k) clearance for its MicroDose SI mammography system, the first full-field digital mammography system which can enable future Single-Shot Spectral Imaging applications.

The company is working on future software applications like Spectral Breast Density Measurement, which will build on the MicroDose SI technology, the company announced.

Single-Shot Spectral Imaging and Spectral Breast Density Measurement applications are not currently available in North America.

Studies have shown women with high breast density are four to five times more likely to get breast cancer than those with lower breast density. Philips noted that there is not yet a standardized method for assessing density, and different radiologists may score breast density differently for the same image.

“Philips believes that spectral imaging technology will be important in helping clinicians to assess breast density and provide personalized care to women,” Lakshmi Gudapakkam, senior vice president and general manager of diagnostic X-ray and mammography solutions at Philips Healthcare. “With the MicroDose SI, Philips contributes to breast cancer screening by delivering the same low dose, high image quality and ergonomics it already offers, while supplying clinicians with spectral-ready technology.”

As with existing MicrDose systems, MicroDose SI uses digital photon-counting technology, which the company said is a shift in mammography by allowing clinicians to use lower radiation dose. Shot Spectral Imaging was developed on the understanding that that breast density is subject to different tissue types and materials that absorb X-rays at various energies, the company said. The technology powering the MicroDose SI separates high and low energy X-ray within one single exposure.