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 ...

In a bid to fortify its Heart Failure business, Abbott ABT recently announced the start of the — GUIDE-HF clinical trial — largest heart failure medical device study in the United States. The trial ...

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, ...

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 ...

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, ...

The CardioMEMS HF monitor doesn’t look important. It’s about the size of a paper clip, or a fishing lure. But it does a very important job. On Jan. 22, Dr. Jeffrey King implanted the device in the ...

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 ...