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Senate proposes new safety requirements for reusable devices

Senate proposes new safety requirements for reusable devices
February 9, 2016

The Senate Committee on Health, Education, Labor and Pensions today favorably reported a bill requiring manufacturers of reusable medical devices like duodenoscopes to submit cleaning instructions and validation data to the FDA before bringing these devices to market. The bill also seeks to clarify FDA guidance on when manufacturers should seek clearance from the agency before marketing their products.

Between 2012 and 2015, there were 25 incidents of drug-resistant infections related to closed-channel duodenoscopes, affecting 250 patients worldwide, according to a recent report.

Meeting News Coverage

Catheter-directed thrombolytic therapy appropriate for PE treatment

February 9, 2016
HOLLYWOOD, Fla. — Modern catheter-directed thrombolytic therapies are safe and effective for treating patients with acute massive or submassive pulmonary embolism…
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Legislators ask for national surveillance of neurological illnesses

February 9, 2016
The Senate health committee today recommended the establishment of a national surveillance system for neurological diseases.The objective of the “Advancing…

Medicare will cover LAA closure device

February 9, 2016
Boston Scientific announced that CMS will cover percutaneous left atrial appendage closure therapy under specific criteria outlined in the agency’s final national…
Breaking News

Senate proposes EHR fix for physicians, patients

February 9, 2016
The U.S. Senate Committee on Health, Education, Labor and Pensions unanimously recommended a measure today that would improve the use of electronic health records for…
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CME

Secondary Prevention of Atherothrombotic Events: Current Insights on Advancing Science

This activity is supported by an educational grant from Merck & Co.

Prevention of cardiovascular disease (CVD) is critical in light of its associated mortality, morbidity, and economic…
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Meeting News CoverageVideo

VIDEO: ‘Real answers’ on mitral valve repair vs. replacement still unclear

February 7, 2016
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VIDEO: Positive CV outcomes with SGLT2 inhibitors mark ‘an exciting time’

Cardiology Today, February 2016
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