March 7, 2013 — Philips Healthcare announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its EchoNavigator live image-guidance tool.


The American Society of Echocardiography (ASE) has released a list of five interventions whose appropriateness physicians and patients should discuss as part of Choosing Wisely, an initiative of the ABIM Foundation, along with Consumer Reports. First in the list, they ask that patients and their doctors talk about the real need for additional echocardiograms when there are only minor signs of heart valve leakage.


CardioNet Inc. announced a multi-year development agreement with the Belgium-based nanoelectronics research center IMEC and its Dutch affiliate Holst Centre. Over the next 18 months, the companies will work to develop two revolutionary cardiac monitoring products.

 Mercator MedSystems Inc. announced it has received CE mark approval to market its Cricket and Bullfrog Micro-Infusion Catheters in Europe, significantly expanding the market for these products, which have previously received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The Mercator micro-infusion catheters are capable of non-systemic delivery of therapeutic agents directly across any peripheral or coronary blood vessel. Initially, these products will be commercialized for the treatment of peripheral artery disease (PAD), a critical health issue affecting 12-14 percent of the general population and nearly 20 percent of those over the age of 70. Approximately 23 million Western Europeans and 17 million Americans have PAD.

March 7, 2013 — Cardiovascular Systems Inc. (CSI) presented three-year data from its ORBIT I feasibility study of calcified coronary lesions during a poster session at the 2013 Cardiovascular Research Technologies (CRT) conference.


As the U.S. government works to strengthen its global nuclear security strategy by eliminating potential sources of bomb-grade highly enriched uranium (HEU), it has eyed the production of medical isotopes for nuclear imaging, which rely on HEU.  To encourage reliable supplies of medical radioisotopes produced from non-HEU sources, President Obama signed into law on Jan. 2, 2013, the American Medical Isotopes Production Act of 2011 (AMIPA). It should be noted that it was part of the 2013 National Defense Authorization Act, so the measure goes beyond interest in just making sure patients have access to radiopharamceutical tracers to enable myocardial perfusion imaging (MPI) scans.  The effort is designed to make HEU sources less available on the world market to reduce the threat of nuclear weapons proliferation or the building of a “dirty bomb.”



In the past few years, especially since the introduction of the iPhone and iPad, there has been an explosion of healthcare related mobile device applications (apps). Most physicians today have smart phones or tablets and are finding ways to integrate them into their daily practice beyond just checking their e-mails. 

 


Brigham and Women’s Hospital in Boston conducted a pilot study of a Web-enabled computerized physician order entry (CPOE) system (another Stage 2 requirement) with embedded imaging decision support. In an effort to reduce the inappropriate use of medical imaging and improve quality of care, it was phased into clinical use between 2000 and 2010 across outpatient, emergency and inpatient departments. The study, published in the Journal of the American College of Radiology in February 2012, showed significant increases in meaningful use for electronically created studies (from 0.4 percent to 61.9 percent) and for electronically signed studies (from 0.4 percent to 92.2 percent) and the adoption of CPOE (from 0.5 percent to 94.6 percent).


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