Selenia nears FDA approval

The FDA issued Hologic an approvable letter in mid-July for its Lorad Selenia digital mammography system. The full-field product is based on an amorphous selenium detector plate developed by Direct Radiography, which Hologic purchased three years ago. The letter, issued in response to a premarket approval application, is the last step before the product is formally accepted by the FDA for sale in the U.S. The letter indicates that the agency will likely allow marketing of Selenia for soft- as well as hard-copy reading. Hologic already has an FDA-approved full-field system, the Lorad Digital Breast Imager. This product, which the FDA approved in March, depends on a charge-coupled detector. Selenia, which uses a more sophisticated direct capture detector, will make this older system obsolete, according to the company.