Remote monitoring device approved for heart patients

(HealthDay)—An implanted wireless device that measures key vital signs in people with heart failure has been approved by the U.S. Food and Drug Administration.

The CardioMEMSHF system measures pulmonary artery pressure and and sends this information remotely to the patient's doctors, the FDA said Wednesday in a news release.

The device is intended for people with New York Heart Association Class III , the FDA said. Some 5.8 million people in the United States have heart failure, in which the heart can't pump enough blood. People with NYHA Class III heart failure have difficulty performing everyday tasks such as walking short distances, the agency said.

The device was evaluated in a clinical study involving 550 people. All devices implanted were still working after six months, the FDA said.

The agency said it is requiring a post-approval study to gather information about the device's long-term performance.

The system is manufactured by CardioMEMS Inc., based in Atlanta.

More information: Visit the FDA to learn more about this approval.

add to favorites email to friend print save as pdf

Related Stories

FDA approves expanded indication for CRT devices

Apr 15, 2014

(HealthDay)—The U.S. Food and Drug Administration has approved an application from Medtronic for revised labeling for two cardiac resynchronization pacemakers (CRT-P) and eight cardiac resynchronization ...

Recommended for you

Poor response to cholesterol drugs may indicate blocked arteries

Feb 26, 2015

If your "bad" cholesterol level stays the same or increases after you take statin drugs, you may have more blocked arteries than people whose levels drop, according to research in the American Heart Association journal Arteriosclerosis, Th ...

Review: more whole grains, less coronary heart disease

Feb 25, 2015

(HealthDay)—Higher dietary intake of whole grains may reduce the risk of coronary heart disease (CHD), according to a meta-analysis published in the March 1 issue of The American Journal of Cardiology.

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.