Mammography firm Hologic has received an approvable letter from the Food and Drug Administration for its Lorad Selenia full-field digital mammography system. Selenia is based on amorphous selenium flat-panel detectors and will be the Bedford, MA, company’s flagship FFDM mammography system when final approval is received.
Hologic previously received regulatory approval for its Lorad Digital Breast Imager system, an FFDM unit based on charge-coupled device (CCD) technology. Hologic, however, has said previously that it will not actively market that unit, instead focusing on Selenia.
Final approval of Selenia’s supplemental premarket approval (PMA) application is contingent on FDA inspection of Hologic’s manufacturing facilities, the company said.
By AuntMinnie.com staff writersJuly 11, 2002
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