Fischer’s SenoScan closes in on FDA PMA approval

Denver x-ray and mammography developer Fischer Imaging received an approvable letter from the FDA on its premarket approval (PMA) application for the SenoScan digital mammography system. The PMA was the result of the company's three-year, 1,500-patient study comparing its digital mammography product with conventional film mammography. Final approval to market the device is expected in coming weeks, pending final FDA review, according to the company.

By staff writers
July 23, 2001

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