Fujifilm submits digital mammo for FDA clearance

Twitter icon
Facebook icon
LinkedIn icon
e-mail icon
Google icon

Fujifilm Medical Systems has submitted its new Aspire HD full-field digital mammography (FFDM) system application to the FDA for 510(k) marketing clearance.

The Aspire HD FFDM system has 50 um pixel resolution, along with Image Intelligence, Fujifilm’s proprietary image processing technology, according to the Stamford, Conn.-based company. Additionally, Aspire HD has a proprietary detector that uses a dual layer amorphous selenium design, coupled with Fujifilm’s Direct Optical Switching (DOS) technology.

The Aspire HD FFDM system requires FDA 510(k) clearance and is not yet available for sale in the U.S.