ATL awaits FDA extension of breast PMA
ATL chairman and CEO Dennis Fill this month said he expects theFood and Drug Administration to approve within the next severalweeks the use of the company's flagship HDI 3000 scanner for differentiatingmalignant from benign solid breast lesions. ATL, of
ATL chairman and CEO Dennis Fill this month said he expects the
Food and Drug Administration to approve within the next several
weeks the use of the company's flagship HDI 3000 scanner for differentiating
malignant from benign solid breast lesions. ATL, of Bothell, WA,
already has FDA approval to differentiate solid breast lesions
using its older Ultramark 9 HDI scanner, and filed a supplemental
premarket approval application with the agency to extend the technique
to HDI 3000 (SCAN 4/24/96). Fill made the comments during a presentation
at the Bear Stearns Health Care Conference in New York City.
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