GE Healthcare’s digital mammography device gets FDA clearance
The US Food and Drug Administration (FDA) has granted 510(k) clearance to GE Healthcare’s new two-dimensional (2D) digital mammography system Senographe Pristina to allow patient-assisted compression.
A standard mammogram involves a low-dose 2D X-ray image of the breast, while digital mammograms use a computer and X-rays to create and show breast images.
The obtained images are analysed by a physician qualified under the Mammography Quality Standards Act to detect abnormalities that require additional workup.
Senographe Pristina with Self-Compression provides patients with an option to increase or decrease the amount of pressure applied to their breast using a handheld wireless remote control.
The self-compression device is used after breast positioning and initiation of compression by the technologist.
Patient-applied compression is later checked by the technologist to ensure adequate application.
FDA Centre for Devices and Radiological Health In Vitro Diagnostics and Radiological Health office director Alberto Gutierrez said: "Regular mammograms are an important tool in detecting breast cancer.
"However, some patients may experience anxiety or stress about the discomfort from the compression during the mammogram.
“This device allows patients some control over the amount of compression for their exam."
FDA found that Senographe Pristina with Self-Compression is substantially equivalent to its predecessor Senographe Pristina, while a clinical validation showed that image quality was not negatively affected by the use of the remote.
It was also demonstrated that patient-assisted compression did not significantly increase the time of the exam.