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This page shows you the most recent publications within this specialty of the MedWorm directory. This is page number 20.

Neusoft Positron Medical Systems Receives ISO Certification And CE Mark For Their Attrius PET System
Positron Corporation (OTCBB:POSC), a leading molecular imaging healthcare company, is pleased to announce that Neusoft Positron Medical Systems Co., Ltd., has received ISO certification (9001:2008 & 13485:2003) and CE Mark approval for their Attrius® PET Systems
Source: Medical Design Online News - August 20, 2012 Category: Medical Equipment Source Type: news

Abbott Announces CE Mark And European Launch Of Next-Generation XIENCE Xpedition™ Drug Eluting Stent
Abbott (NYSE: ABT) today announced that the XIENCE Xpedition™ Everolimus Eluting Coronary Stent System received CE Mark in Europe for the treatment of coronary artery disease
Source: Medical Design Online News - August 20, 2012 Category: Medical Equipment Source Type: news

Ulthera Receives Clearance To Market Ultrasound Platform Device In Brazil
Ulthera, Inc. -- a global, high-growth medical device company pioneering aesthetic and medical applications using its therapeutic ultrasound platform technology -- today announced that it is now registered in Brazil to market and distribute its patented medical device, the Ulthera System
Source: Medical Design Online News - August 20, 2012 Category: Medical Equipment Source Type: news

ZOLL And Inovise Medical Enter Technology Partnership
ZOLL Medical Corporation, a manufacturer of medical devices and related software solutions, announced today it has entered into an agreement to license Inovise Medical, Inc.’s ambulatory AUDICOR technology as part of the advanced patient diagnostics in the LifeVest Wearable Defibrillator
Source: Medical Design Online News - August 20, 2012 Category: Medical Equipment Source Type: news

Roche Diagnostics to Invest a Whopping $300 Million in Indianapolis to Support Expansion of its Clinical Lab Testing Business
Roche is refocusing its resources as it works to rebalance its businesses in pharmaceuticals and clinical laboratory testing Roche Diagnostics is pumping $300 million into its North American headquarters in Indianapolis. At the same time, the Roche research and development campus in Nutley, New Jersey will be closed. Collectively both actions are a sign of [...]
Source: Dark Daily - August 20, 2012 Category: Laboratory Medicine Authors: jude Tags: Laboratory Hiring & Human Resources Laboratory News Laboratory Pathology Bloustein School of Planning and Public Policy clinical laboratory Dark Daily Fierce Medical Devices genetic testing Illumina in vitro diagnostics Indystar.com Source Type: news

Smiths Medical And Nexus Medical Sign Distribution Agreement For Nexus TKO Anti-Reflux Needle-Free Technology
Smiths Medical, a leading global medical device manufacturer, announced today that they have signed an agreement with Nexus Medical, LLC to distribute the company’s family of Nexus TKO anti-reflux needle free valves and extension sets in the U.S. and Canada
Source: Medical Design Online News - August 20, 2012 Category: Medical Equipment Source Type: news

Identifying Commonly Counterfeited Analgesic Using Simple New Test
In a thrust against the major problem of counterfeit medicines sold in developing countries, which causes thousands of illnesses and deaths annually, scientists thave described development of a simple, paper-strip test that people could use to identify counterfeit versions of one of the most-frequently faked medicines in the world. Their report on an inexpensive test to identify fake tablets of Panadol was presented at the 244th National Meeting & Exposition of the American Chemical Society, the world's largest scientific society...
Source: Health News from Medical News Today - August 20, 2012 Category: Consumer Health News Tags: Medical Devices / Diagnostics Source Type: news

FDA caught running 'paranoid, retaliatory' institutionalized spying ring
The U.S. Food and Drug Administration (FDA), which has been explicitly tasked under the law with overseeing the safety of food, drugs, and medical devices for the purpose of protecting the American people, has officially been exposed for engaging in a massive, agency...
Source: NaturalNews.com - August 20, 2012 Category: Consumer Health Advice Source Type: news

FDA SpyGate -- New Revelations Challenge The New York Times Investigation of Agency "Enemies List," Raise More Questions About the 'Government's Most Dysfunctional Agency'
According to Jon Entine, after a series of stumbles and scandals, the Food and Drug Administration’s ability to oversee the most cutting edge sectors of the medical industry, medical device and genetic screening tests, is under more scrutiny.
Source: Forbes.com Healthcare News - August 20, 2012 Category: Pharmaceuticals Authors: Jon Entine Source Type: news

Federal Register: Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 029
The FDA is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards).
Source: Food and Drug Adminstration (FDA): CDRHNew - August 20, 2012 Category: Medical Equipment Source Type: news

Federal Register: ASTM International-Food and Drug Administration Workshop on Absorbable Medical Devices: Lessons Learned From Correlations of Bench Testing and Clinical Performance
FDA is co-sponsoring the workshop together with ASTM International, an organization responsible for the development and delivery of international voluntary consensus standards for engineered products, including medical devices. The purpose of this...
Source: Food and Drug Adminstration (FDA): CDRHNew - August 20, 2012 Category: Medical Equipment Source Type: news

Asante Installs 15 Toshiba Ultrasound Units
To upgrade its ultrasound systems across three facilities, Asante in Medford, Ore., purchased 15 of Toshiba’s newest ultrasound systems for its Asante Three Rivers Medical Center, Asante Rogue Regional Medical Center and the Asante Imaging facility
Source: Medical Design Online News - August 19, 2012 Category: Medical Equipment Source Type: news

Gore Receives CE Mark For GORE Hybrid Vascular Graft
W. L. Gore & Associates (Gore) has received CE Mark for the GORE Hybrid Vascular Graft. The graft is designed to expand treatment options for optimal outflow by maximizing the number of access sites available
Source: Medical Design Online News - August 19, 2012 Category: Medical Equipment Source Type: news

Coming Next: Doctors Prescribing Apps to Patients
Apps that can assess data like blood glucose levels, diet and drug regimen — and can be reimbursed by insurance — will soon be prescribed by doctors to help treat patients.
Source: NYT Health - August 19, 2012 Category: Consumer Health News Authors: By JOSHUA BRUSTEIN Tags: Doctors Medical Devices Health Insurance and Managed Care Greater New York Hospital Assn Mobile Applications Source Type: news

Loophole in FDA's Approval Process for Medical Devices Prompts Letter from Congress
A proposal to keep potentially flawed medical devices from entering the market made its way to the Food and Drug Administration this week, with two congressmen asking the agency to reform its approval process for new devices that are modeled after existing, but later recalled, products.
Source: Forbes.com Healthcare News - August 17, 2012 Category: Pharmaceuticals Authors: Gergana Koleva Source Type: news

Past-President Discusses Importance of Supply Chain Integrity
The U.S. Pharmacopeial Convention (USP), of which the Society of Critical Care Medicine (SCCM) is a member, has drafted a document recommending best practices to ensure supply chain integrity for drug components and products. Good Distribution Practices -- Supply Chain Integrity highlights strategies to combat counterfeit drugs and medical devices and avoid theft and diversion. Supply chain integrity has been a major issue as the pharmaceutical industry globalizes, procuring materials from distant sources through complex distribution paths with multiple handoffs. Counterfeit heparin was identified in the United States and ...
Source: SCCM RSS News - August 17, 2012 Category: Intensive Care Source Type: news

Fluorescent Molecules That Can Be Turned On And Off In Aqueous Environments To Visualize Activity Within Cells
University of Miami scientists have developed a way to switch fluorescent molecules on and off within aqueous environments, by strategically trapping the molecules inside water-soluble particles and controlling them with ultraviolet light. The new system can be used to develop better fluorescent probes for biomedical research. Previous studies have used water-soluble particles to bring organic molecules into water. What is novel about this system is the use of a photoswitching mechanism in combination with these particles...
Source: Health News from Medical News Today - August 17, 2012 Category: Consumer Health News Tags: Medical Devices / Diagnostics Source Type: news

New Research Indicates Up To 60 Million Americans Suffer From Hammertoe Foot Deformities
Nextremity Solutions, Inc. announced preliminarily results of a new market research analysis indicating that forefoot deformities, such as hammertoes, are an endemic problem in the United States affecting as many as 20% of Americans. According to Andrew Park, Senior Manager, Orthopedics at iDATA Research, a global medical device and pharmaceutical market intelligence firm, commented, "People who suffer from forefoot deformities remain one of the largest untreated orthopedic patient populations our firm has ever measured...
Source: Health News from Medical News Today - August 17, 2012 Category: Consumer Health News Tags: Bones / Orthopedics Source Type: news

Important Information On The Medical Device User Fee Rates for FY 2013
This letter provides the medical device user fee information, including fee rates and payment procedures, for Fiscal Year (FY) 2013 that runs from Oct. 1, 2012, through Sept. 30, 2013.
Source: Food and Drug Adminstration (FDA): CDRHNew - August 17, 2012 Category: Medical Equipment Source Type: news

Evaluation of Automatic Class III Designation (De Novo) Summaries (K093579 added)
Source: Food and Drug Adminstration (FDA): CDRHNew - August 17, 2012 Category: Medical Equipment Source Type: news

F.D.A. Asks St. Jude for More Studies on Flawed Heart Device
The decision was made by the Food and Drug Administration after a wire that connects a defibrillator to a patient’s heart caused unintended shocks. St. Jude Medical stopped selling the wire in 2010.
Source: NYT Health - August 16, 2012 Category: Consumer Health News Authors: By KATIE THOMAS Tags: Defective Products St Jude Medical Inc STJ NYSE Food and Drug Administration Medical Devices Source Type: news

Report: Med-device integration with EMR driving market growth
More than half of U.S. hospitals, 54 percent, plan to purchase products designed to help integrate medical devices with EMRs over the next two years.
Source: CMIO.net: The News Weekly for Health IT Executives - August 16, 2012 Category: Information Technology Tags: Latest News Source Type: news

Legislators ask FDA to improve database for device safety
Congressional lawmakers expressed concern with a flaw in an FDA regulatory process that expedites approval of medical devices similar to previously approved devices. A law requires the FDA to clear a device substantially similar to a predicate, even if the the updated model contains the same design flaws that caused the earlier model to be recalled.
Source: CMIO.net: The News Weekly for Health IT Executives - August 16, 2012 Category: Information Technology Tags: Latest News Source Type: news

IRIS International Selects ThingWorx For Next-Generation Remote Service And Support Of Medical Devices
IRIS International, Inc. is using the ThingWorx connected application platform to build its next-generation remote service management platform. The platform will enhance IRIS’ innovative iCARE™ (IRIS’ Customer Appreciation and Relationship Experience) program with high-value remote service, monitoring, and automation.
Source: Pharmaceutical Online News - August 16, 2012 Category: Pharmaceuticals Source Type: news

Samaritan Health Services selects iSirona for medical device integration
iSirona®, a provider of simplified solutions for medical device integration, today announced that Samaritan Health Services has signed an agreement to implement iSirona's device connectivity software. Located in Oregon's mid-Willamette Valley and central coast, Samaritan Health Services will leverage iSirona's flexible software-based technology to deliver quality patient data into its Epic EMR. read more
Source: Healthcare IT News Press Releases - August 16, 2012 Category: Information Technology Authors: Industry News Release Tags: Industry News iSirona Oregon PANAMA CITY Samaritan Health Services simplified solutions Source Type: news

Excelsior Medical Announces Issuance Of Second U.S. Patent On SwabFlush
Excelsior Medical Corporation announced that the United States Patent and Trademark Office (USPTO) has issued new US Patent No. 8,231,602 to the company
Source: Medical Design Online News - August 16, 2012 Category: Medical Equipment Source Type: news

First Cardiac Surgery With Domain Surgical FMwand Completed At Beaumont Hospital
Domain Surgical, a medical device company developing advanced thermal surgical technology for soft tissue cutting and coagulation, today announced that its FMwand Ferromagnetic Surgical System was used for the first time in cardiac surgery
Source: Medical Design Online News - August 16, 2012 Category: Medical Equipment Source Type: news

Renal Denervation Device Market To Grow Dramatically, But Physicians Will Still Consider Cost-Effective Tradeoffs When Making Purchase Decisions
According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, renal denervation, a promising new treatment for drug-resistant uncontrolled hypertension, has the potential to be a blockbuster medical device
Source: Medical Design Online News - August 16, 2012 Category: Medical Equipment Source Type: news

Groundbreaking Technology Looks Deep Inside The Body
Tiny space age probes - those that can see inside single living cells - are increasingly being used to diagnose illness in hard-to-reach areas of the body. NewYork-Presbyterian Hospital/Weill Cornell Medical Center's Dr. Michel Kahaleh often threads a tiny microscope into the narrow bile ducts that connect the liver to the small intestine to hunt for cancer. He also uses the device to minutely explore the pancreatic duct as one of a few doctors in the country to use such technology in this way. But because these devices are comparatively new, Dr...
Source: Health News from Medical News Today - August 16, 2012 Category: Consumer Health News Tags: Medical Devices / Diagnostics Source Type: news

New Photoacoustic Technique Detects Multiple Nerve Agents Simultaneously
To warn of chemical attacks and help save lives, it's vital to quickly determine if even trace levels of potentially deadly chemicals - such as the nerve gas sarin and other odorless, colorless agents - are present. U.S. Army researchers have developed a new chemical sensor that can simultaneously identify a potentially limitless numbers of agents, in real time. A paper describing the system has been published in the Optical Society's (OSA) journal, Optics Letters...
Source: Health News from Medical News Today - August 16, 2012 Category: Consumer Health News Tags: Medical Devices / Diagnostics Source Type: news

Federal Register: Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice; Public Workshop
The public workshop is designed to aid the clinical research professional's understanding of the mission, responsibilities, and authority of the FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships...
Source: Food and Drug Adminstration (FDA): CDRHNew - August 16, 2012 Category: Medical Equipment Source Type: news

FDA Safety Communication: Premature Insulation Failure in Recalled Riata Implantable Cardioverter Defibrillator (ICD) Leads Manufactured by St. Jude Medical, Inc.
Riata and Riata ST leads connect an implantable cardioverter defibrillator (ICD) to the heart in order to monitor heart rhythms. ICD's can detect life-threatening heart rhythms and deliver an electrical shock from the ICD through the lead to the heart...
Source: Food and Drug Adminstration (FDA): CDRHNew - August 16, 2012 Category: Medical Equipment Source Type: news

Internal Microscopic Diagnostic Devices - Clinicians Need More Training
To diagnose illness in areas of the body that are hard-to-reach, clinicians increasingly use tiny space age probes, which can see inside single living cells. A new study published in the journal Digestive Diseases and Sciences reveals that specialists who are beginning to use these devices may be interpreting what they see in different ways. Dr...
Source: Health News from Medical News Today - August 15, 2012 Category: Consumer Health News Tags: Medical Devices / Diagnostics Source Type: news

PwC: Medical device industry sees waning venture capital
Venture capitalists are finding the medical device industry less and less lucrative, according to a recent MoneyTree Report, published by PricewaterhouseCoopers LLP (PwC) in conjunction with the National Venture Capital Association (NVCA). Report findings show venture capital (VC) for the Life Sciences sector, which includes biotechnolgy and the medical device industry, dipped 30 percent in VC funding dollars and 22 percent in deals for Q2 compared to the same quarter last year. read more
Source: Healthcare IT News - August 15, 2012 Category: Information Technology Authors: Erin McCann Tags: Online Only biotechnology Erin McCann New York NVCA PricewaterhouseCoopers LLP Tracy T. Lefteroff venture capital Financial/Revenue Cycle Management Policy and Legislation Source Type: news

Government seeks views on cosmetic surgery
A “major cosmetic surgery review” has been launched, The Daily Telegraph has reported. It added that the industry faces “tough new regulations over fears that patients are being misled over the safety of procedures”. The news – picked up in most of the print, broadcast and online media – is based on a government announcement of a “call for evidence” as part of an ongoing review of cosmetic surgery and other cosmetic procedures. Professor Sir Bruce Keogh, NHS medical director, is leading the review. The government announcement was accompanied by an opinion poll of 1,762 people which found that only half too...
Source: NHS News Feed - August 15, 2012 Category: Consumer Health News Tags: QA articles Medical practice Source Type: news

Class I Medical Device Recall: Certain Covidien Shiley Adult Tracheostomy Tubes
Reason for Recall: Covidien is recalling certain cuffed Shiley tracheostomy tubes due to consumer complaints related to reports of volume leakage and/or disconnection between the inner and outer cannulae, which were observed during mechanical...
Source: Food and Drug Adminstration (FDA): CDRHNew - August 15, 2012 Category: Medical Equipment Source Type: news

PwC to U.S. med-device industry: Be prepared
Manufacturers of medical devices “must prepare to respond to the FDA’s new unique device identification (UDI) provisions, which could require serialization not only of finished products but also constituent components. This may require manufacturers to rethink sourcing and supplier monitoring processes.”
Source: CMIO.net: The News Weekly for Health IT Executives - August 14, 2012 Category: Information Technology Tags: Latest News Source Type: news

Lanx(R) Announces U.S. Patent Granted for ASPEN(TM) MIS Fusion System
BROOMFIELD, Colo., Aug. 14, 2012 (GLOBE NEWSWIRE) -- Lanx(r), Inc., a privately held medical device company focused on developing and commercializing innovative devices for spinal surgery, announces that the U.S. Patent and Trademark Office today granted patent #8241330 for the ASPEN(tm) MIS Fusion System technology, designed to support spinal fusion.
Source: Medical News (via PRIMEZONE) - August 14, 2012 Category: Pharmaceuticals Source Type: news

Managed Markets Agency Element Marketing Group Inc. Appoints New Head...
Element Marketing Group Inc. (EMG), a leader in reimbursement marketing and strategy for pharmaceutical, biotech and medical device companies, recently announced the appointment of Michelle Whitlock...(PRWeb August 14, 2012)Read the full story at http://www.prweb.com/releases/2012/8/prweb9787394.htm
Source: PRWeb: Medical Pharmaceuticals - August 14, 2012 Category: Pharmaceuticals Source Type: news

New Materials Prevent Infection By Stopping Biofilm Formation
Using state-of-the-art technology scientists at The University of Nottingham have discovered a new class of polymers that are resistant to bacterial attachment. These new materials could lead to a significant reduction in hospital infections and medical device failures. Medical device associated infections can lead to systemic infections or device failure, costing the NHS £1bn a year. Affecting many commonly used devices including urinary and venous catheters - bacteria form communities known as biofilms...
Source: Health News from Medical News Today - August 14, 2012 Category: Consumer Health News Tags: Infectious Diseases / Bacteria / Viruses Source Type: news

Summary Information for: LINX? Reflux Management System
Labeling, Approval Order, and Summary of Safety and Effectiveness for LINX? Reflux Management System (P100049).
Source: Food and Drug Adminstration (FDA): CDRHNew - August 14, 2012 Category: Medical Equipment Source Type: news

Dental Cone-beam Computed Tomography
Cone-beam computed tomography systems (CBCT) are a variation of traditional computed tomography (CT)1 systems. The CBCT systems used by dental professionals rotate around the patient, capturing data using a cone-shaped X-ray beam. These data are used...
Source: Food and Drug Adminstration (FDA): CDRHNew - August 14, 2012 Category: Medical Equipment Source Type: news

Codman Receives FDA PMA Approval For MEDSTREAM™ Programmable Infusion System
Codman & Shurtleff, Inc. (Codman), the global neurological device company, has received U.S. Food and Drug Administration (FDA) approval through a PMA supplement for its MEDSTREAM™ Programmable Infusion System, an implantable infusion pump and catheter system used in the treatment of spasticity, a movement disorder often caused by stroke, cerebral palsy, multiple sclerosis or spinal cord injury
Source: Medical Design Online News - August 13, 2012 Category: Medical Equipment Source Type: news

Unprecedented Study Shows Berlin Heart Device Provides Life-Saving "Bridge" For Young Children And Babies
A tiny heart pump that maintains blood flow in babies and small children with serious heart failure proved effective and life-saving in a pioneering study involving 17 institutions led by Texas Children's Hospital and Baylor College of Medicine (BCM). A report on this study appears today in the New England Journal of Medicine
Source: Medical Design Online News - August 13, 2012 Category: Medical Equipment Source Type: news

Stryker Announces FDA Clearance Of Trevo® Pro Retrieval System
Stryker Neurovascular announced today that its Trevo® Pro Retriever has been granted 510(k) market clearance by the U.S. Food and Drug Administration
Source: Medical Design Online News - August 13, 2012 Category: Medical Equipment Source Type: news

New Medical Devices Get Smart
Adjustable prostheses and other high-tech devices may benefit patients who have a tendency to ignore or delay care, but they also raise concerns that they could give patients a false sense of security.
Source: WSJ.com: Health - August 13, 2012 Category: Pharmaceuticals Tags: PAID Source Type: news

Benchmark Products-Sterile and Non-Sterile Cleanroom Products
Benchmark Products is a designer and distributor of a broad range of cleanroom products primarily for the pharmaceutical, medical device and life science critical manufacturing environments.
Source: Pharmaceutical Technology - August 13, 2012 Category: Pharmaceuticals Source Type: news

Manhattan Scientifics Achieves Significant Milestones In Pursuit Of Its Early Cancer Detection And Treatment Technology
Manhattan Scientifics announced today that it has achieved several critical milestones in the development of its proprietary technology for the early detection and treatment of cancer
Source: Medical Design Online News - August 13, 2012 Category: Medical Equipment Source Type: news