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 ...

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 ...

When Phyllis Brooks came to a local hospital due to shortness of breath, she was transferred to McLaren Greater Lansing Hospital, where further testing confirmed her diagnosis of a heart condition, ...

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 ...

Will heart failure sensor startup CardioMEMS be wireless health's first big acquisition target? Medical device maker St. Jude Medical just announced a $60 million equity investment in CardioMEMS, ...

Please provide your email address to receive an email when new articles are posted on . Medical therapy helps many patients with heart failure, but some also need device therapy. A new consensus ...

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 ...

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, ...