Atlanta, Georgia-based health device maker CardioMEMS received FDA clearance for its CardioMEMS HF System, which monitors pulmonary artery pressure, but for patients who have experienced New York ...
The CardioMEMS HF System is proven to significantly reduce heart failure hospitalizations and improve quality of life in NYHA class III HF patients St. Jude Medical now intends to exercise its ...
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 ...
WASHINGTON, Dec 5 (Reuters) - U.S. health regulators on Monday said a CardioMEMs implant for treating heart failure met its main safety and effectiveness targets but warned of potential bias in the ...
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 ...
MARION — Congestive heart failure can be unpredictable and scary with little hope of living very long. One second you are on your feet and the next you’re in an ambulance on your way to the ER. But ...
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, ...
WEST CHESTER – Changes in lung blood pressure can signal big trouble for people with heart failure. Now, thanks to a tiny implantable device being offered at Chester County Hospital, these changes can ...
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 ...