Hologic's Lorad division has received an approvable letter from the U.S. Food and Drug Administration for its Lorad Full-Field Digital Mammography system. The agency's action should be the end of a long regulatory road for Lorad, which has struggled to get the FFDM system to market.
The approvable letter applies to Lorad's FFDM premarket approval (PMA) application, filed earlier this year. The PMA was based on three years of clinical data collected at major medical institutions around the world, according to the company.
Lorad's previous corporate parent, Trex Medical, originally tried to gain approval for the product under the 510(k) process. But after two years under review, the FDA stymied that effort in 1999 by ruling that the system was not substantially equivalent to analog mammography systems and therefore had to go through the PMA process.
Hologic of Bedford, MA, said that final clearance for the product is subject to labeling discussions, a good manufacturing practices audit, and other details. Hologic is also developing a second-generation FFDM system that will use its DirectRay amorphous selenium flat-panel digital technology. This system will require a separate FDA review, Hologic said.
By AuntMinnie.com staff writersOctober 26, 2001
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