GAITHERSBURG, Maryland — The second go of the Champion heart failure monitor at an FDA advisory hearing squeaked by with a final vote of 6-4 (with one abstention) that the device offers a reasonable assurance that the benefits outweigh the risks. Seemingly counterintuitively, the panel voted 7-4 that the data did not offer a reasonable assurance that the device is effective for the proposed indication, but the outstanding safety record of the device, made by CardioMems (Atlanta) gave a couple of panelists the breathing room they needed to swing back over in favor of the device on the final vote. Read More
