US-based Fujifilm Medical Systems has received 510(k) approval from the US Food and Drug Administration (FDA) for its new breast imaging solution, Aspire Cristalle.
The Aspire Cristalle combines detector engineering with patient focused ergonomics, and offers faster more confident diagnosis for clinicians and exceptional patient comfort.
Initially, the company has commercialised the breast imaging solution in Asia and Europe.
Fujifilm Medical Systems Digital X-ray and Women’s Health marketing and product development director Rob Fabrizio said: "The Aspire Cristalle will deliver brilliant images with gentle dose, while redefining the patient experience through a notably more comfortable exam."
The company said that new advancements of the Aspire Cristalle include Comfort Paddle and Hexagonal Close Pattern (HCP).
Comfort Paddle features soft edges, flexible composition and four-way pivot contours to the individual shape of the breast to more comfortably apply compression for optimal tissue separation.
Additionally, the system also includes new patient grip handles and padding for added stability and comfort.
HCP is a detector pixel design, engineered to provide higher acquisition efficiency, for finer detail, higher DQE, higher MTF and lower dose than conventional square pixel arrays.
According to the company, image quality of the system is further improved with its image processing, iAEC automated exposure controls and ISC precisely tuned contrast, to adapt to specific characteristics for every breast type and to image implants with ease.