it’ll be rubber stamped next week. Or next month. Or next year or decade. Or never. Anybody’s guess.
does anybody know more details about the new stricter device regulations that have come in in Europe? Saw this on BSI’s website.,Do they affect OSL’s submission possibly? In current climate with recent device controversies would take a courageous regulator to put neck on the line and approve for marketing a radioactive device that’s shown safety in only small study and has no proven efficacy/benefit and where patients have alternatives.
Ann: CE Mark Update, page-278
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