Sectra Receives FDA Approval for MicroDose Mammography System

Sectra has received FDA approval for its MicroDose Mammography system. The system, which has been available in many other countries already for several years, promises to lower radiation dose by half compared to other digital or film-based systems while still obtaining high-quality images. It achieves this by using digital photon counting technology which detects X-ray photons individually, eliminating the signal loss that happens in analog system components. The image is acquired by a multi-slit scanning technology that eliminates scattered radiation and significantly reduces the noise level in the image. Images are captured with a resolution of 25 megapixels, a much larger resolution than that of most other digital systems.
From the product brochure:

The direct capture of the individual X-rays occurs without the analogue to digital conversion steps used by other FFDM systems. The result: no information loss.
The image is acquired by a scanning method using a patented multi-slit collimator, eliminating 97% of scattered radiation. Furthermore, the signals from the individual photons are clearly separated from the background electronic noise. Together, these factors significantly reduce the noise level in the image.
Since Sectra’s photon counting detector is fast enough to be ready when the next photon arrives, there are no “ghost images” or artifacts to interfere with image interpretation or slow down your workflow.
Dose efficiency refers to the image quality you get from a specific dose. Efficient scatter rejection and photon
counting detectors result in dose-efficient systems, allowing for a low radiation dose imaging while maintaining
excellent image quality.
A pixel size of 50 ?m enables a resolution of 25 Megapixels. You can see even the finest structures in the breast – microcalcifications and spiculations, for example – at half the radiation dose.
Flat panel systems typically have part of the detector surface covered by read out electronics, leading to waste
of dose and active pixel area. Thanks to the design of the photon counting detector, 100% of the detector surface is active, putting every single photon to use.
Equipped with the fastest and most efficient detector on the market, Sectra MicroDose users perform as many as 15 four-image examinations per hour. The system allows for even higher productivity if needed.
SmartAEC™ – This unique feature optimizes exposure during the scan. There is no additional dose from scout images. Clinically proven, with correct exposure in over 97% of the images.

Press release: Sectra receives FDA clearance for MicroDose Mammography modality…
Product page: Sectra MicroDose Mammography…
Product brochure…