WASHINGTON (Reuters) - A Food and Drug Administration review of CardioMEMS' device for treating heart failure found it has met its main safety and effectiveness goals, based on trial results. But the ...

CardioMEMS ran into a regulatory roadblock last week, when an FDA advisory panel recommended that the agency not approve the company's Champion HF Monitoring System. The device is said to be the first ...

Columbus, OH - Heart-failure patients managed with a wireless implantable hemodynamic monitoring system had a significant and large reduction in hospitalizations compared with standard management, ...

GAITHERSBURG, MD (updated) — A Food and Drug Administration (FDA) advisory committee narrowly voted in favor of a novel device that measures pulmonary-artery (PA) pressures in patients with heart ...

A local Medicare contractor issues a final ruling declining to cover CardioMEMS, the wireless, implantable heart failure management device from St. Jude Medical. Arundhati Parmar St. Jude Medical has ...

The Medicare coverage story of the Cardiomems device has a Homeric air about it, spanning nearly a decade starting with an adverse local coverage determination in 2016. Abbott Park, Ill.-based Abbott ...

ATLANTA, Aug. 26 -- CardioMEMS, Inc., a medical technology company that has developed and is commercializing proprietary wireless sensing and communication technology for the human body, today ...

Nearly 6.7 million adults in the U.S. have heart failure, with prevalence expected to rise to 8.5 million by 20301,2. While heart failure is a chronic, progressive disease, advances in technology are ...