Hologic files PMA for Lorad digital mammography system

May 3, 2001

Hologic has moved closer to its goal of commercializing a full-field digital mammography system. The Bedford, MA-based vendor has filed a premarket approval application with the Food and Drug Administration for its Lorad charge-coupled device (CCD)-based unit.

The development of the Lorad FFDM system is the culmination of more than three years of clinical testing and analysis, said Hologic chairman and CEO David Ellenbogen.

This will be the second go-round at the FDA for the Lorad product. First submitted by Trex Medical, the system spent two years under review by the FDA, a process that culminated in a 1999 decision that found the system not equivalent to analog mammography systems. Although it marketed the Trex Digital Mammography System in Europe for several years, Trex was unable to get the system through the FDA’s 510(k) process. Hologic acquired Trex Medical in September.

Hologic's plans for digital mammography are not limited to CCD technology, however. Thanks to its digital x-ray program, acquired through its purchase of Digital Radiography Corp. (DRC), Hologic has amorphous selenium flat-panel detector technology, and will utilize it for digital mammography. Once the CCD-based system is cleared, the vendor plans to submit a supplementary application for amorphous selenium flat-panel detectors as an option to the unit.

"We’re marrying DRC technology to Trex systems," president and COO Steve Nakashige told AuntMinnie.com in February. "We plan to capitalize on the CCD digital system data Lorad had in the works and develop a machine based on this technology initially, then convert as quickly as possible to selenium detectors cleared in a supplement to our application. We hope this will shorten the lead time to market."

By Erik L. Ridley
AuntMinnie.com staff writer
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