ATL awaits FDA extension of breast PMA

Article

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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