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Congressional Democrats Seek to Fix Flaws in Med Device Approval Process
02/03/2012 -- WASHINGTON, D.C. - Thousands of patients have suffered grave health effects from faulty medical devices cleared by the Food and Drug Administration (FDA) solely because they were considered similar to other devices - even if the original device was recalled for major safety problems. To protect patients from defective devices, Reps. Edward J. Markey (D-Mass.), Henry A. Waxman (D-Calif.), Jan Schakowsky (D-Ill.), and Rosa DeLauro (D-Conn.), introduced H.R. 3847, the Safety Of Untested and New Devices Act of 2012 (SOUND Devices Act).
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Boston Sci Launches Percutaneous Lead for Spinal Cord Stimulator System in Europe
PARIS and MIAMI BEACH, Florida, February 3, 2012 /PRNewswire/ -- Boston Scientific Corporation announces CE Mark approval of the Infinion(TM) 16 Percutaneous Lead for its Precision Plus(TM) Spinal Cord Stimulator (SCS) System, the first rechargeable SCS device for chronic pain management. The first patient implant in Europe using the Infinion(TM) 16 Lead was performed by Kliment Gatzinsky, M.D., Ph.D., and David Revesz, M.D., of the Neurosurgery Department atthe Sahlgrenska University Hospital in Guldheden, Sweden.
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DexCom, Tandem Diabetes Care Announce Glucose Monitor Agreement
2/3/2012 -- SAN DIEGO--(BUSINESS WIRE)-- DexCom, Inc. (NASDAQ:DXCM), a leader in continuous glucose monitoring systems, announced that it has entered into a Development and Commercialization Agreement with Tandem Diabetes Care, Inc. to integrate a future generation of DexCom's continuous glucose monitoring (CGM) technology with Tandem's t:slim(TM) Insulin Delivery System, the first ever touch-screen insulin pump.
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Colibri Heart Valve Is Issued Patent for Method of Making Replacement Heart Valves
BROOMFIELD, CO, Feb. 2, 2012 (GLOBE NEWSWIRE) -- Colibri Heart Valve, LLC, a privately held medical device company, received an Issue Notification from the U.S. Patent and Trademark Office regarding the forthcoming granting of its U.S. Patent No. 8,109,995 titled, "Percutaneously Implantable Replacement Heart Valve Device And Method Of Making Same." The patent will issue on February 7, 2012 and is directed to a method of making a percutaneously implantable replacement transcatheter aortic heart valve using a folding technique covering both bovine and porcine pericardium.
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Regulatory Harmonization Institute, Korea Health Industry Development Institute to Globalize Korean Healthcare Industry
2/3/2012 -- ELMWOOD PARK, N.J.--(BUSINESS WIRE)-- The Regulatory Harmonization Institute, Inc. (RHI) an international, not-for-profit association dedicated to global harmonization of drug and medical device regulatory requirements, and the Korea Health Industry Development Institute (KHIDI), the Korean government organization, announced to partner in support of the 2012 Columbus Project, a Korean government program to boost globalization of Korea's healthcare industry.
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ETView Medical Ltd., State of the Art Medical Products Execute Distribution Agreement
2/3/2012 -- TEL AVIV, Israel--(BUSINESS WIRE)-- ETView Medical Ltd. (TASE: ETVW) announced that it has entered into a distribution agreement with State of the Art (SOTA) Medical Products, Inc. The agreement enables SOTA to market ETView's VivaSight(TM) platform (previously known as TVT(TM)), combining an airway ventilation tube with integrated continuous high resolution airway imaging for patient airway control and lung isolation capability in New York, New Jersey, Pennsylvania and Delaware for a period of 3 years. Other terms were not announced.
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BodyMedia Files Patent Infringement Suit Against Basis Science
PITTSBURGH, Feb. 2, 2012 /PRNewswire/ -- BodyMedia, Inc., the leader in wearable body monitors, announced that it has filed a patent infringement suit against BASIS Science, Inc. in the U.S. Federal District Court in Delaware for willfully infringing BodyMedia's breakthrough patented wearable body monitoring devices and sensor fusion technology. The Company asserts that BASIS Science has been marketing a new product that uses BodyMedia's inventions as the foundation for its technology.
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VentriPoint Launches Updated Heart Analysis System in Europe and Canada
SEATTLE, WASHINGTON--(Marketwire - Feb. 2, 2012) - VentriPoint Diagnostics Ltd. (TSX VENTURE:VPT) (PINKSHEETS:VPTDF) has released its latest version of the VMS(TM) heart analysis system. Over the last year of installing systems, customers have provided invaluable feedback on the operation and use of VMS(TM), and their suggestions have now been incorporated into version 1.1 of VMS(TM).
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Boston Scientific Announces Fourth Quarter and 2011 Results
NATICK, Mass., Feb. 2, 2012 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announces financial results for the fourth quarter and full year ended December 31, 2011, as well as sales and earnings per share (EPS) guidance for the first quarter and full year 2012. Fourth quarter highlights: Generated sales of $1.848 billion and achieved GAAP earnings of $0.07 per share and adjusted EPS of $0.13, both within the Company's EPS guidance range
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Merit Medical Announces Purchase of Ostial Solutions Assets
SOUTH JORDAN, Utah, Feb. 1, 2012 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc.
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