Fuji gets FDA nod for digital mammo

Fujifilm Medical Systems USA has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Aspire Cristalle digital mammography system, already commercialized in Europe and Asia.

The new system combines innovative detector engineering with attention to ergonomics, resulting in faster and better diagnostic power for clinicians and more comfort for patients, the company said.

Patient experience enhancements in Cristalle include a Comfort Paddle designed to make mammography more comfortable with soft edges, flexible composition, and four-way pivot contours that help apply compression comfortably, Fuji said. Patient grip handles and padding also add stability and comfort for the patient.

Fuji's detector pixel design known as Hexagonal Close Pattern (HCP) is engineered to deliver better efficiency of image acquisition with finer image details and lower radiation dose than conventional square pixel arrays, according to the company. Image quality is further enhanced with Fuji's iAEC image processing for automated exposure.