Hologic nears US digital mammography market:
This article was originally published in Clinica
Executive Summary
Hologic has moved closer to the US full field digital mammography (FFDM) system market, after receiving an approvable letter from the FDA for its Lorad system. The device, which is now undergoing the final phase of the premarket approval review process, uses CDC-based technology to generate digital mammographic images. The Bedford, Massachusetts firm is also in the advanced stages of development of a second-generation digital mammography system that incorporates its amorphous selenium DirectRay direct-to-digital technology. Only two other firms have US marketing approval for a FFDM system - GE Medical Systems and Fischer Imaging.