Fujifilm’s Breast Imaging Device Receives 510(k) Clearance from FDA

Fujifilm Medical Systems U.S.A. said Wednesday that the FDA has cleared its Aspire Cristalle breast imaging solution for marketing in the U.S. It is now available nationwide.

According to the Hanover Park, Ill., devicemaker, the product combines innovative detector engineering with enhanced ergonomics for increased patient comfort. Aspire Cristalle also will allow for more confident diagnoses, the company says.

Features include the Fujifilm’s patented Comfort Paddle with soft edges, flexible design and four-way pivot contours to make mammograms more comfortable and create optimal tissue separation. The device also uses Hexagonal Close Pattern detector pixel design, which delivers images in finer detail, more efficiently and at a lower dose than conventional square pixels, the company says.

Aspire Cristalle’s image quality is heightened using Fujifilm's image processing, automated exposure controls and precisely tuned contrast, which adapts to specific characteristics for every breast type and images implants with ease, Fujifilm says.

The device was first commercialized under the name Amulet Innovality in Asia and Europe. It received the CE mark in July 2013. — Kellen Owings

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.