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 ...

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 ...

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 ...

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 ...

There is more than meets the eye when it comes to CardioMEMS and its heart failure monitoring device that St. Jude Medical recently acquired for $375 million. Surgeons implant the smaller-than-a-dime ...

After rejecting it the first time, FDA has approved the world’s first implantable wireless heart monitoring device to manage chronic heart failure patients remotely. Though approved, FDA is requiring ...

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 ...

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 ...

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 ...