Remote monitoring device approved for heart patients

May 29, 2014

(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.

Explore further: FDA OKs first compact heart-assist device

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

Related Stories

FDA OKs first compact heart-assist device

April 21, 2008

The U.S. Food and Drug Administration announced approval of a compact heart-assist device that's the first to be designed for a small-sized adult.

FDA approves expanded indication for CRT devices

April 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 defibrillators (CRT-D). ...

Daily aspirin regimen not safe for everyone, FDA warns

May 6, 2014

(HealthDay)—Taking an aspirin a day can help prevent heart attack and stroke in people who have suffered such health crises in the past, but not in people who have never had heart problems, according to the U.S. Food and ...

Recommended for you

Amyloid-related heart failure now detectable with imaging test

August 24, 2016

A type of heart failure caused by a build-up of amyloid can be accurately diagnosed and prognosticated with an imaging technique, eliminating the need for a biopsy, according to a multicenter study led by researchers at Columbia ...

Biomarkers may help better predict who will have a stroke

August 24, 2016

People with high levels of four biomarkers in the blood may be more likely to develop a stroke than people with low levels of the biomarkers, according to a study published in the August 24, 2016, online issue of Neurology, ...

0 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.