Mammography and digital x-ray developer Hologic has received Food and Drug Administration approval of a premarket approval (PMA) application for its Lorad digital breast imaging system.
Hologic received an approvable letter for the charge-coupled device (CCD)-based full-field digital mammography system (FFDM) in October. While the approval is an important milestone for the Bedford, MA-based vendor, Hologic doesn't plan to market the CCD-based unit.
Instead, Hologic said it would complete the final development and regulatory steps necessary to incorporate its DirectRay amorphous selenium detectors into the unit before it begins shipping FFDM systems. The amorphous selenium-based unit, dubbed Selenia, is in the final stages of development and will require separate FDA review, according to the firm.
By AuntMinnie.com staff writersMarch 19, 2002
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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
Hologic gets FFDM approvable letter, October 26, 2001
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