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)
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)
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)