FDA panel votes no on heart-mon­i­tor­ing de­vice

Modern Healthcare - - LATE NEWS -

A Food and Drug Ad­min­is­tra­tion ad­vi­sory panel voted against ap­prov­ing Car­diomems’ wire­less, per­ma­nently im­plantable de­vice that would al­low car­di­ol­o­gists to re­motely mon­i­tor heart­fail­ure pa­tients. Panel mem­bers voted 9-1 that the de­vice is safe but con­cluded that they could not de­ter­mine whether the de­vice is ef­fec­tive, ac­cord­ing to a news re­lease from At­lanta-based Car­diomems. They also con­cluded that rea­son­able as­sur­ance of the risks as­so­ci­ated with the tech­nol­ogy out­weighed the po­ten­tial

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