Comfort, Image Enhanced in FDA Cleared Breast Imaging Solution

Aspire Cristalle, a new digital mammography breast imaging solution with innovative and methodical features, by Fujifilm, received U.S. Food and Drug Administration (FDA) 510(k) clearance yesterday.

The Aspire Cristalle uses novel detector engineering called hexagonal close pattern (HCP), a detector pixel design engineered to deliver higher acquisition efficiency, finer detail, higher DQE, higher MTF and lower dose than conventional square pixel arrays, according to a release. “[The design is] engineered to produce brilliant images at low dose,” the release stated.

Fujifilm’s image processing, iAEC automated  exposure controls and ISC precisely tuned contrast, also enhances the image quality, according to the release. The processing adapts to the specific characteristics for every breast type and implants, the release said.

Patient comfort was also considered in the new mammography solution. Fujifilm included their patented “Comfort Paddle,” in the Aspire Cristalle, which is designed to ease the discomfort of mammograms, the release said. The paddle boasts soft edges, flexible composition and a 4-way pivot contours to the individual shape of the breast for a more 

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comfortable application of compression for optimal tissue separation, the release stated. Patient grip handles, padding for added stability and comfort, and soft backlighting and graphic mural decals were incorporated for further patient comfort. The system also allows

improved access for wheelchair exams, the release said.

 “Aspire Cristalle nicely represents our latest culmination of imaging innovation and attention to every detail in design,” Rob Fabrizio, director of marketing and product development, digital X-ray and women’s health, FUJIFILM Medical Systems USA, Inc., said in a release. “The Aspire Cristalle will deliver brilliant images with gentle dose, while redefining the patient experience through a notably more comfortable exam.”