August 9, 2012 — CardioDx Inc. announced that Palmetto GBA, a national contractor that administers Medicare benefits, has established coverage for the company’s Corus CAD gene expression test for the evaluation of patients presenting with typical and atypical symptoms suggestive of coronary artery disease (CAD).

August 9, 2012 — The U.S. Food and Drug Administration (FDA) is informing healthcare providers and patients that the indications for use and labeling for the Stryker Wingspan Stent System have changed to limit the use of Wingspan to a narrow, select group of patients and conditions.

August 9, 2012 — The Harvard Clinical Research Institute (HCRI) announced today the successful completion of randomization in the DAPT study, with the total number of patients randomized exceeding the upper goal set for the study.

Aug. 8, 2012 — The U.S. Food and Drug Administration (FDA) approved the Abbott’s Omnilink Elite Vascular Balloon-Expandable Stent System for the treatment of iliac artery disease. This form of peripheral artery disease (PAD) that affects the lower extremities can progress to where patients experience chronic pain and reduced ability to walk, potentially leading to permanent disability.

Aug. 8, 2012 — Vascular Solutions Inc. launched the SuperCross FT, a new flexible-tip version of its line of SuperCross microcatheters. It is designed to address the majority of complex interventional procedures in which a flexible tipped microcatheter is needed.

Aug. 8, 2012 — The Berlin Heart Group said the U.S. Food and Drug Administration (FDA) has granted approval for its post approval study, a condition of the humanitarian device exemption (HDE) approval that Berlin Heart received for the Excor Pediatric Ventricular Assist Device (VAD) in December 2011.

 
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