Hologic gets approvable letter for Selenia FFDM system

AuntMinnie.com staff writers

Jul 10, 2002

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 writers
July 11, 2002
Related Reading

Hologic comments on stock dip, June 13, 2002

Hologic gets clearance for FFDM system, March 19, 2002

Hologic lands HPG deal, February 28, 2002

Hologic issues secondary offering, December 17, 2001

Hologic and Siemens to form FFDM alliance, November 26, 2001

Hologic files for public offering, November 19, 2001

Hologic gets 510(k) for entry-level mammography system, November 1, 2001

Copyright © 2002 AuntMinnie.com

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