The U.S. Food and Drug Administration (FDA) has granted Clinical Laboratory Improvement Amendments (CLIA)-waived status to the Roche CoaguChek XS Plus system. The point-of-care anticoagulation monitor offers connectivity and data management tools to help healthcare professionals manage PT/INR (blood clotting time) testing. The waiver means that the monitoring technology may now be used in a broader range of clinical settings, such as labs that do not meet the requirements to perform moderate- or high-complexity testing as defined by the CLIA of 1988.

Imagine a place where doctors can tell patients in advance if cancer treatment will work for them, without going through an entire course of chemotherapy.

Advocate Health Care, one of the nation's top health systems and the largest integrated health care system in the state of Illinois, and GE Healthcare, a national leader in low dose, high performance imaging, announced a joint effort to help further reduce radiation dose in computed tomography (CT). The goal is to optimize care for patients needing imaging procedures and reduce radiation where possible without adversely impacting image quality. It’s one of the first announcements of the GE Blueprint for low dose, a comprehensive campaign in which GE Healthcare is working alongside leading U.S. health systems to further reduce radiation dose in CT imaging. Leaders from Advocate and GE Healthcare unveiled the Advocate-based GE Blueprint for low dose today during an event at Advocate Lutheran General Hospital.

LipoScience Inc., a highly innovative diagnostic company that is advancing patient care by developing high value proprietary blood tests using nuclear magnetic resonance (NMR) technology, announced the publication of results from a clinical study in the American Journal of Cardiology (AJC) suggesting that despite having cholesterol levels considered acceptable by today’s clinical standards, patients with Type 2 diabetes mellitus (T2DM) are at increased risk for cardiovascular disease (CVD)-related events.

The American Medical Association (AMA) Current Procedural Terminology (CPT 1) Editorial Panel has assigned Category I CPT codes specifically for bronchial thermoplasty in its recently published CPT 2013 Professional Edition.  Beginning Jan. 1, 2013, physicians and hospitals will be able to seek reimbursement through two new codes to describe the bronchial thermoplasty procedure.  Category I CPT procedure codes are recognized by all public and private health insurance payers in the United States.

Researchers at the University of Maryland School of Medicine, who are exploring novel ways to treat serious heart problems in children, have conducted the first direct comparison of the regenerative abilities of neonatal and adult-derived human cardiac stem cells. Among their findings: cardiac stem cells (CSCs) from newborns have a three-fold ability to restore heart function to nearly normal levels compared with adult CSCs. Further, in animal models of heart attack, hearts treated with neonatal stem cells pumped stronger than those given adult cells. The study is published in the Sept. 11, 2012, issue of Circulation.

Aptus Endosystems Inc. announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its thoracic-length HeliFX Aortic Securement System. Similar to the original HeliFX system that was cleared in November 2011 and designed for treating abdominal aortic aneurysms (AAA), the new system consists of a longer delivery device with additional tip configurations to bring the innovative helical EndoAnchor technology to the treatment of thoracic aortic aneurysms (TAA).

This year’s European Society of Cardiology (ESC) Congress in Munich, Germany, was a stark example of exactly where the cardiovascular market space is headed. This congress fully emphasized the new and innovative technologies that are coming out on the medical device and medical technology side, while leaving the market’s pharmaceutical wing in the dust. In fact, out of the nine hours over three days and 18 seminars on cardiac therapy innovation, only one seminar, given by Amgen, spoke about a pharmaceutical interventional treatment for heart disease. Thus, if there is one message to take away from the ESC 2012 congress, it is that the pharmaceutical industry has moved away from the cardiovascular market

Subscribe to
© Copyright Wainscot Media. All Rights Reserved.
Subscribe Now