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By Sherrie Conroy, Director of Content
A new study on the 510(k) process missed the mark and drew the ire of industry groups AdvaMed and the Medical Imaging & Technology Alliance (MITA). A colleague says the study “compares apples to kumquats,” meaning, of course, that the data used in the study should not even have been compared to one another in the first place. AdvaMed and MITA both say the study contains factual errors, faulty data analysis, and recommendations that would harm patient access to medical technology with no corresponding safety benefit.
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While the benefits of the new healthcare bill continue to be debated in Washington and around the dinner table, there’s one irrefutable fact: The healthcare landscape as we know it continues to dramatically change, and technologies enabling in-home medical care are significantly contributing to this transformation.
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AdvaMedDx, a division of the Advanced Medical Technology Association (AdvaMed) that is focused solely on opportunities and challenges facing companies that discover, develop, and manufacture diagnostic technologies, announced veteran policy analyst Tharini Sathiamoorthy will join the group as its new associate vice president.
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Free Webinar: Improve Plastic Adhesion with Atmospheric Plasma
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 Unlock the secrets of using atmospheric plasma and flame surface treating to improve adhesion and functionalize surfaces. Learn how these in-line technologies can reduce costs and improve productivity. Applications for printing, coating, decorating and bonding surfaces without chemicals or liquid primers will be reviewed. The webinar will feature live video of plasma technology in operation. Presented by renown plasma expert and author Rory Wolf of Enercon Industries.
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Nile Therapeutics Inc announced plans to collaborate with Medtronic Inc on the clinical development of Nile’s proprietary natriuretic peptide, cenderitide (formerly CD-NP), for heart failure and renal disease applications. Nile focuses on the development of novel therapeutics for heart failure patients. Financial terms were not disclosed.
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Materials are designed to serve as a lead alternative for radiation and EMI/RFI shielding in medical devices used in home, outpatient, and long-term care environments. Specialty thermoplastic compounds provider Sabic Innovative Plastics, Pittsfield, MA, offers two compounds created to meet pending changes to the lead replacement exemption for Category 8 products under the EU’s RoHS directive, as well as cost-effectiveness and flexibility requirements.
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Literature on New HYDAK® HydroSleek Coatings
for Medical Devices
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 Based on a high molecular weight hyaluronic acid (HA), new HYDAK HydroSleek Coatings confer lubricity as well as durability without the property trade-offs often experienced with other coatings. The proprietary two layer coating system consists of a hyaluronic acid top coat covalently bound to a polyacrylate base coat which can easily be applied to a wide range of different polymeric and metallic substrates, as well as lumens.
Heat curing allows for uniform and consistent coating properties through the entire cross section. Click here for literature.
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Designed to help reduce and prevent device-related infection, an acrylic-based multipolymer compound is suitable for use in medical devices that incorporate antimicrobial agents. Cyrolite Protect from Evonik Cyro, Essen, Germany, is a green-tinted transparent antimicrobial compound for Class I and II devices.
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Medical-grade polymer colorants are suitable for use in such applications as medical device housings and medical packaging made using blow molding, injection molding, or extrusion processes. The OnColor HC Plus line of colorants from Avon Lake, OH-based PolyOne Corp, a provider of specialized polymer materials, is precertified to meet or exceed ISO 10993 requirements.
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MICROMO
Worlds first micro-processor controlled prosthetic leg use lightweight dc motors. Providing clear benefits for users of both safety and comfort. www.micromomedical.com
Boker's 2011 Washer Catalog
Boker's 2011 Washer Catalog features over 25,000 non-standard flat washer sizes, available with no tooling charges, outside diameters of 0.080" to 5.140" and over 2,000 material options for endless possibilities.
www.bokers.com/mee
Design Cube from Protomold
Our Design Cube illustrates important considerations when designing plastic injection molded parts. It showcases a range of available surface finishes and examples of bosses, gussets, and ribs. It also demonstrates the impact on part quality of overly thick or thin sections, as well as ways to incorporate holes and their potential effect on resin flow. Register today and get yours free
Medical Molding
Precision plastic components for Medical OEM projects require more than tight tolerances and consistent quality. They often require manufacturing in a clean environment and a solid understanding of the application or related standards. Learn More
Translate technical documents accurately and cost-effectively
International Language Services seamlessly manages your multi-language translation projects: IFUs, labels, user manuals and more. Download our white paper, "How to write for translation."
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