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Welch Allyn to introduce new EHR Preparation and Selection program to ASGE members

Welch Allyn, a leading global manufacturer of frontline medical products and solutions, today announced a strategic partnership with the American Society for Gastrointestinal Endoscopy (ASGE) that will offer the more than 11,000 members of this international organization a unique service designed to ease the process of selecting and preparing for an electronic health record (EHR) system. ASGE promotes the highest standards for endoscopic training and practice, fosters endoscopic research and is the foremost resource for endoscopic education.

7 Sep 2010

FDA grants Teleflex 510(k) clearance for ArrowEVOLUTION PICC with Chlorag+ard technology

Teleflex Incorporated today announced that it has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the company's ArrowEVOLUTION™ PICC with Chlorag+ard™ technology, a peripherally inserted central catheter with a Chlorhexedine-based solution that has been chemically-bonded into the surface of the catheter both intra- and extralumenally. Teleflex will launch the product for general availability in the United States in the fourth quarter.

7 Sep 2010

Quintiles new lab in Japan achieves CAP accreditation

Quintiles today announced that its new lab in Tokyo, Japan has received accreditation from the College of American Pathologists (CAP), joining the largest network of fully harmonized, CAP-accredited central labs in the world.

7 Sep 2010

Medtronic launches CoreValve delivery system with AccuTrak Stability Layer for TAVI

Medtronic, Inc. today announced CE Mark approval and the first global use and launch of the Medtronic CoreValve® delivery system with AccuTrak™ Stability Layer for transcatheter aortic valve implantation (TAVI). AccuTrak's proprietary technology allows physicians to achieve enhanced control and accuracy in the deployment of the CoreValve device.

7 Sep 2010

VirtualScopics enters molecular imaging collaboration with ABX-CRO

VirtualScopics, Inc., a leading provider of quantitative imaging for clinical trials, today announced it has entered into a scientific collaboration, specific to molecular imaging, with ABX-CRO, a Dresden, Germany based full-service contract research organization. The collaboration joins two of the scientific pioneers in the use of advanced imaging for the clinical study of drugs and medical devices.

7 Sep 2010

AtheroMed initiates enrollment in Phoenix Atherectomy catheter trial for PAD

AtheroMed, Inc. announced today the start of enrollment in the EASE study to evaluate the safety and effectiveness of the Phoenix Atherectomy™ catheter, a minimally invasive device for the treatment of peripheral arterial disease (PAD) in the legs. EASE - Endovascular Atherectomy Safety and Effectiveness - is an FDA-approved Investigational Device Exemption (IDE) clinical trial that will enroll 90 patients at up to 20 clinical sites.

7 Sep 2010

Carolinas Healthcare System and Medicity partner to build multi-state health information exchange

Carolinas HealthCare System, one of the leading healthcare organizations in the Southeast with 32 affiliated hospitals in North and South Carolina, announced today it has selected Medicity as its partner to build a multi-state health information exchange.

7 Sep 2010

K2M granted FDA clearance for CHESAPEAKE Anterior-Lumbar Stabilization System

K2M, Inc., a spinal device company developing innovative solutions for the treatment of complex spinal pathologies, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration to market its new CHESAPEAKE™ Anterior-Lumbar Stabilization System, a unique interbody device designed for stabilization of the spine through an anterior approach. The system provides screw fixation through K2M's revolutionary tifix® Locking Technology, whereby each screw head forms an autogenic lock to the implant upon insertion.

7 Sep 2010

TSO3 engaged in regulatory discussions for refiling of new generation sterilizer's 510(k) clearance

TSO3 Inc., an innovator in sterilization technology for medical devices in healthcare settings, today announced that the Company is having productive discussions with US regulators, including a very recent face-to-face meeting. The Company is actively engaged in the changing US regulatory process intended to lead to the refilling for 510(k) clearance on its new generation sterilizer.

7 Sep 2010

Nassau University Medical Center to include Streamline Health Solutions' HIM Suite of workflows

Streamline Health Solutions, Inc. a leading provider of document workflow solutions for hospitals, today announced that Nassau University Medical Center in East Meadow, New York, will expand its software licensing arrangement to include Streamline Health's Enterprise Health Information Management Suite of workflows.

7 Sep 2010

AuthenTec, UPEK combine to expand fingerprint sensors and identity management software

AuthenTec, a leading provider of security, identity management and touch control solutions, and privately-held UPEK, a leading supplier of fingerprint solutions for consumer, business and government applications, announced that the companies have combined, creating the world's largest provider of fingerprint sensors and identity management software, as well as biometric and embedded security solutions.

7 Sep 2010

Bruker launches Icon desktop MRI systems at 2010 World Molecular Imaging Congress

At the 2010 World Molecular Imaging Congress in Kyoto, Bruker Corporation today announces the introduction of the Icon™, a new easy-to-use 1 Tesla desktop MRI scanner that combines simplicity with compact dimensions, in order to bring preclinical magnetic resonance imaging (MRI) within reach for a broader range of molecular imaging laboratories.

7 Sep 2010

Bend Research expands hot-melt extrusion pharmaceutical manufacturing capabilities

Bend Research Inc., a leading independent drug-formulation development and manufacturing company, announced today that it is expanding its pharmaceutical manufacturing capabilities for hot-melt extrusion.

7 Sep 2010

University of Maryland School of Medicine orders AVANCE III 950 US2 NMR spectrometer from Bruker

Bruker Corporation announces a major order from the University of Maryland School of Medicine for its ultra-high field AVANCE III 950 US2 NMR spectrometer. The 950 MHz Nuclear Magnetic Resonance magnet and spectrometer will help University of Maryland researchers to unravel the mysteries of molecules and develop new agents to treat cancer, AIDS and other diseases.

7 Sep 2010

miacom diagnostics presents rapid detection method for pneumonia causing pathogens

miacom diagnostics specializes on the development and production of medical tests for the detection of acute infectious diseases. In addition to its existing sepsis kits miacom, diagnostics is now presenting a further CE-marked product based on the same proprietary technology. It is targeted at the rapid detection of clinically most relevant pneumonia causing pathogens.

7 Sep 2010

Bruker announces NIST order for AVANCE III 900 NMR spectrometer

Bruker Corporation, the leader in analytical magnetic resonance instrumentation, today announces a major order from the National Institute of Standards and Technology (NIST) for its ultra-high field AVANCE™ III 900 US2 NMR spectrometer.

7 Sep 2010

Water Pik launches first line of sinus wash products

Today, Water Pik, Inc., a global leader in personal healthcare products, announced the launch of its first line of sinus wash products, Waterpik SinuSense. A brand new category for Water Pik, the SinuSense™ name introduces four products to the brand's portfolio, including the Squeeze Bottle, Neti Pot, Neti Bottle and the Water Pulsator - the first and only products of their kind in this category.

7 Sep 2010

Popularity of e cigarettes increase despite FDA's stance

Electronic cigarette sales and popularity continues to increase on a daily basis despite the US Food and Drug Administration's attempts to label the products as unsafe and untested for their intended purpose. Thousands of electronic cigarette reviews online dispute the stance of the FDA, many of them stating that the products have not only been tested, but by and large have been found to be less harmful than traditional cigarettes.

7 Sep 2010

RevMed secures contract with Medical Investment to produce fixed needle safety syringe

RevMed has secured a binding 5 Year contract to produce 5M syringes/month of its 3mL fixed needle safety syringe with Medical Investment Group, LLC (MIG). MIG, a Massachusetts Limited Liability Company, will fulfill this obligation through its relationship with an internationally certified global medical device manufacturer.

7 Sep 2010

FDA grants IRIS clearance for analysis of synovial fluid with iQ200, iRICELL automated microscopy analyzers

IRIS International, Inc., a leading manufacturer of automated in-vitro diagnostic systems and consumables for use in hospitals and commercial laboratories worldwide and provider of high value personalized diagnostics testing services through its CLIA certified molecular diagnostics laboratory, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the analysis of synovial fluid as a new product application in its Body Fluids Module utilizing its iQ®200 and iRICELL® automated microscopy analyzers.

7 Sep 2010

Device / Technology News

Welch Allyn to introduce new EHR Preparation and Selection program to ASGE members

FDA grants Teleflex 510(k) clearance for ArrowEVOLUTION PICC with Chlorag+ard technology

Quintiles new lab in Japan achieves CAP accreditation

Medtronic launches CoreValve delivery system with AccuTrak Stability Layer for TAVI

VirtualScopics enters molecular imaging collaboration with ABX-CRO

AtheroMed initiates enrollment in Phoenix Atherectomy catheter trial for PAD

Carolinas Healthcare System and Medicity partner to build multi-state health information exchange

K2M granted FDA clearance for CHESAPEAKE Anterior-Lumbar Stabilization System

TSO3 engaged in regulatory discussions for refiling of new generation sterilizer's 510(k) clearance

Nassau University Medical Center to include Streamline Health Solutions' HIM Suite of workflows

AuthenTec, UPEK combine to expand fingerprint sensors and identity management software

Bruker launches Icon desktop MRI systems at 2010 World Molecular Imaging Congress

Bend Research expands hot-melt extrusion pharmaceutical manufacturing capabilities

University of Maryland School of Medicine orders AVANCE III 950 US2 NMR spectrometer from Bruker

miacom diagnostics presents rapid detection method for pneumonia causing pathogens

Bruker announces NIST order for AVANCE III 900 NMR spectrometer

Water Pik launches first line of sinus wash products

Popularity of e cigarettes increase despite FDA's stance

RevMed secures contract with Medical Investment to produce fixed needle safety syringe

FDA grants IRIS clearance for analysis of synovial fluid with iQ200, iRICELL automated microscopy analyzers

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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