"Uncertain future" for CardioMEMS’ Champion after lukewarm panel vote
This article was originally published in Clinica
Executive Summary
The chances of US approval of CardioMEMS’ Champion heart failure monitoring system hang in the balance once again, after a split decision from an FDA advisory panel. This is the second time the device has fallen foul of one of the agency’s panels; the first being in December 2011 (www.clinica.co.uk, 12 December 2011).