The US Food and Drug Administration (FDA) has granted 510(k) clearance to Royal Philips Electronics' full-field digital mammography (FFDM) system.
Having the capability to enable future Single-Shot Spectral Imaging applications like Spectral Breast Density Measurement, the MicroDose SI system uses digital photon-counting technology to enable clinicians to conduct exams using low radiation dose without compromising image quality.
Single-Shot Spectral Imaging 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.
The technology powering the MicroDose SI uses the fundamental behavior of X-rays and allows clinicians to see more than just a shadow in mammogram images by separating high and low energy X-ray within one single exposure.
Philips Healthcare diagnostic X-ray and mammography solutions senior vice president and general manager Lakshmi Gudapakkam said the company believes that spectral imaging technology will help clinicians to assess breast density and provide personalized care to women.
"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," Gudapakkam added.
Medical University of South Carolina College of Medicine dean Etta Pisano said, "I look forward to getting the unit installed at MUSC."
