CardioKinetix Inc. announced that it has enrolled more than half of the subjects in its pivotal United States trial, PARACHUTE IV. The trial is evaluating the Parachute device for the treatment of patients suffering from heart failure, a highly debilitating condition.

The Centers for Medicare and Medicaid Services (CMS) announced Monday that it will be ending the Meaningful Use program that was meant to encourage the adoption of electronic medical records (EMR).

Sapien III, Sapien 3, PARTNER III
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January 15, 2016 — The U.S. Food and Drug Administration (FDA) has given its approval for an expanded indication study of Edwards' Sapien 3 valve in low-risk patients. This will be the first U.S. study of a transcatheter aortic valve replacement (TAVR) device in this patient population, which would normally receive an open-heart surgical valve replacement. If TAVR proves to be at least equal in outcomes to surgery, it will likely cause a paradigm shift in the standard of care.

January 14, 2016 — Cornell biomedical engineers have discovered natural triggers that could reduce the chance of life-threatening, congenital heart defects among newborn infants. Those triggers can override developmental, biological miscues, leading to proper embryonic heart and valve formation.

Penumbra Inc. announced the U.S. launch of its new POD Packing Coil, designed as a complementary device for Penumbra’s Ruby and POD (Penumbra Occlusion Device) embolization products.

The American Medical Association (AMA) announced that it is investing $15M to become founding partner of a healthcare innovation company — Health2047 Inc.

Ionizing radiation can save lives, but it can also cause serious harm. Getting the right measurement of exposure to ionizing radiation in any situation is at the heart of an ISO standard that has recently been updated.

Even though brain natriuretic peptide (BNP)/pro-BNP and troponin biomarkers are the gold standard for cardiac disease diagnosis, end users will soon see additional alternative biomarkers entering the market, according to analysis from Frost & Sullivan.


Beyond measuring blood flow, pressure, oxygen levels and other vital signs in the cardiac catheterization lab, current hemodynamic recording systems are an integral part of clinical reporting. Hemodynamic data from newer systems helps auto-completion of data fields in procedure reports, can automate gathering registry data, and can help interface cath lab patient data with the patient’s electronic medical record (EMR).
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