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October 1, 2012 — CircuLite Inc. announced that the latest data from patients enrolled in the company’s CE mark trial of the Synergy Circulatory Support System strengthened prior findings indicating that implantation with Synergy resulted in significant, sustained improvements in hemodynamics and exercise tolerance.

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September 28, 2012 — MindChild Medical Inc. announced that it has received 510(k) premarketing notification clearance from the U.S. Food and Drug Administration (FDA) for its Meridian noninvasive fetal heart monitor, and anticipates entering the U.S. market with Meridian soon. Additional pre-market regulatory filings are anticipated during 2012 and 2013.

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September 28, 2012 — Accumetrics Inc., developer of the VerifyNow System, the first rapid and easy-to-use point-of-care system for measuring platelet reactivity to multiple antiplatelet agents, announced the launch of its Quality Improvement and Value Assessment Program.

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Abbott Bioabsorbable Stent  Absorb
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The world’s first drug-eluting bioabsorbable vascular scaffold has been launched and will revolutionize the stent industry. On Sept. 25, 2012, Abbott announced the launch of its drug-eluting bioabsorbable stent, Absorb, in Europe, the Middle East and parts of Asia Pacific and Latin America. Absorb, which received CE mark certification in 2011, is used to treat coronary artery disease. Bioabsorbable stents, such as Absorb, will broaden treatment and diagnostic options, reduce the need for long-term anti-platelet therapy and reduce the risk of in-stent restenosis and thrombosis.

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September 28, 2012 — Boston Scientific Corp. announced it has received U.S. Food and Drug Administration (FDA) clearance for the Emerge percutaneous transluminal coronary angioplasty (PTCA) balloon dilatation catheter, and has begun marketing the device in the United States.

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Medtronic Inc. announced it has received CE mark for its Medtronic CoreValve Evolut 23 mm valve, its latest self-expanding transcatheter aortic valve implantation (TAVI) system.

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Boston Scientific has launched the Promus Element Plus BTK (Below The Knee) everolimus-eluting stent system in European countries for the treatment of certain severe peripheral artery lesions. The drug-eluting stent (DES) has CE mark approval for both monorail and over-the-wire (OTW) versions and will be available immediately.

Home September 27, 2012
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The average age of installed magnetic resonance imaging (MRI) scanners in the United States has increased from eight years in 2007 to 10.9 years in 2011, according to a new market research report by IMV Medical Information Division.

Home September 26, 2012
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The American College of Cardiology (ACC) has certified Lumedx software as fully interoperable between four ACC NCDR registries. Lumedx, a leading provider of integrated cardiovascular imaging and information systems, is currently the only software vendor offering this level of interoperability.

Home September 26, 2012
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Abbott bioresorbable Absorb stent BVS
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Abbott Vascular began its international launch of the Absorb coronary stent, the world's first drug-eluting bioresorbable vascular scaffold (BVS). It is now widely available across Europe and parts of Asia Pacific and Latin America. The Absorb is a first-of-its-kind device for the treatment of coronary artery disease (CAD).

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September 25, 2012 — Patients are often aggressively treated with anticoagulants, or blood thinners, to help prevent pulmonary emboli from forming, but a study published in the September 2012 issue of the Journal of the American Academy of Orthopaedic Surgeons indicates that some blood clots being identified by today's sensitive testing methods may not require aggressive treatments.

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Sept. 25, 2012 — America's healthcare system has become too complex and costly to continue business as usual, says a new report from the Institute of Medicine. Inefficiencies, an overwhelming amount of data and other economic and quality barriers hinder progress in improving health and threaten the nation's economic stability and global competitiveness, the report says. However, the knowledge and tools exist to put the health system on the right course to achieve continuous improvement and better quality care at lower cost, added the committee that wrote the report.

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MedAxiom ASNC Nuclear Imaging
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A new survey reveals that cardiologists around the United States are seeing more patients than ever before, yet performing fewer advanced nuclear tests on those patients on average. The survey cites a change in the approach to the delivery of cardiovascular care, as well as continued concerns about economic conditions, as reasons for the decline.

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According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, the saturated U.S. X-ray market will grow slowly to reach a value of $2.8 billion by 2016. Significant growth will be seen in digital replacement systems in all segments of the market.

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The new U.S. Food and Drug Administration Safety and Innovation Act (FDASIA) imposes many Medical Device Establishment Registration and Listings requirements, effective Oct. 1, 2012. To assist the medical device industry, Registrar Corp has provided the following list of top 10 things that medical device professionals need to know regarding FDASIA:

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