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BioWorld - Wednesday, December 31, 2025
Home » Authors » Mark McCarty

Articles by Mark McCarty

DES clash not yet over, but BMS, CABG lose ground

Nov. 1, 2009
By Mark McCarty

Brazilian trial data nearly doom Asthmatx's Alair PMA

Oct. 30, 2009
By Mark McCarty
GAITHERSBURG, Maryland — The idea of inserting ablative devices into the heart is old hat by now, but inserting an ablation device into the lungs is a novelty. Novel or not, the anesthesiology and respiratory devices advisory committee met Wednesday to review a PMA for just such a technology. (Medical Device Daily)
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Washington roundup: FDA publishes guidance on computer-assisted detection

Oct. 29, 2009
By Mark McCarty

Washington roundup: McClellan: inflation driven by devices 'well worth it'

Oct. 28, 2009
By Mark McCarty

Reader variability seen as a key for whole slide images

Oct. 27, 2009
By Mark McCarty
GAITHERSBURG, Maryland — FDA has decisions to make about clinical trials for digitized images of pathology slides, but Friday's second-day session of the hematology and pathology devices advisory committee gave industry few hints about what the agency will require in those trials. (Medical Device Daily)
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Washington roundup: Medicare 'doc fix' bill dies in Senate; SGR still in play

Oct. 23, 2009
By Mark McCarty

Monitors an issue for FDA in digital pathology imaging

Oct. 23, 2009
By Mark McCarty
GAITHERSBURG, Maryland – There is no novelty to the assertion that technology drives FDA's regulations, so the fact that FDA would convene a two-day session with the hematology and pathology devices advisory committee to discuss how to reliably employ digital images of pathology slides in diagnostic workups is not a surprise. (Medical Device Daily)
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Washington roundup: Philips said to be clear of issues in warning letter

Oct. 22, 2009
By Mark McCarty

Washington roundup: Baxter snared by FDA warning for changes to manufacturing

Oct. 21, 2009
By Mark McCarty

Washington roundup: FDA reports inter-agency review of QoL for LASIK

Oct. 19, 2009
By Mark McCarty
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