Fujifulm’s Aspire Cristalle digital mammography solution received FDA clearance yesterday and includes features promoting patient comfort and image quality.
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
[[{"type":"media","view_mode":"media_crop","fid":"25470","attributes":{"alt":"Fujifilm Aspire Cristalle","class":"media-image media-image-right","id":"media_crop_1823864043690","media_crop_h":"283","media_crop_image_style":"-1","media_crop_instance":"2326","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"137","media_crop_x":"0","media_crop_y":"0","style":"margin: 1px; border-style: solid; line-height: 1.538em; width: 150px; height: 310px; float: right;","title":" ","typeof":"foaf:Image"}}]]
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.”
Study: Mammography AI Leads to 29 Percent Increase in Breast Cancer Detection
February 5th 2025Use of the mammography AI software had a nearly equivalent false positive rate as unassisted radiologist interpretation and resulted in a 44 percent reduction in screen reading workload, according to findings from a randomized controlled trial involving over 105,000 women.
Can AI Bolster Breast Cancer Detection in DBT Screening?
January 16th 2025In sequential breast cancer screening with digital breast tomosynthesis (DBT), true positive examinations had more than double the AI case score of true negative examinations and the highest positive AI score changes from previous exams, according to new research.
Mammography Study Suggests DBT-Based AI May Help Reduce Disparities with Breast Cancer Screening
December 13th 2024New research suggests that AI-powered assessment of digital breast tomosynthesis (DBT) for short-term breast cancer risk may help address racial disparities with detection and shortcomings of traditional mammography in women with dense breasts.
Mammography News: FDA Grants Expanded 510(k) Clearance for AI-Powered SmartMammo Dx DBT Software
November 29th 2024Originally cleared by the FDA in 2021, the SmartMammo Dx software for digital breast tomosynthesis (DBT) can now be utilized with the Senographe Pristina mammography systems from GE HealthCare.