FDA reported May 28 it approved the CardioMEMS device, a heart failure remote monitoring device PMA that tanked at an advisory hearing in 2011. The application re-appeared at the circulatory systems advisory panel in 2013, however, leaving FDA with enough feedback to approve the device, which some observers believe could tamp down on the rehospitalizations that drive up healthcare costs. The reimbursement question lingers, however, pending a decision by the Centers for Medicare & Medicaid Services on the sponsor's application for a new technology add-on payment. Read More
