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 By Joe Jancsurak, Editor
FDA's Medical Device Innovation Initiative, a priority review program for breakthrough medical devices, is the subject of a recent eight-page AdvaMed document. Signed by Janet Trunzo, executive vice president of technology and regulatory affairs, it includes praises and a detailed critique of the FDA effort.
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The proposed American Research and Competitiveness Act of 2011 has the support of AdvaMed. The bill modernizes research and development tax policies by reducing the maximum income tax rate on corporations to 25% of corporate taxable income exceeding $50,000. It also provides a special rule for any taxable year in 2011 by establishing a maximum 30% rate for corporate taxable income exceeding $75,000.
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There’s a bonding solution for just about every substrate combination, but some solutions may lead to expensive tradeoffs. Olefinic materials, for example, can be adhesively bonded but only if a primer or surface treatment figures into the equation, adding time and cost to the assembly process.
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The very thing that many blame for slowing down the whole time-to-market process—regulatory approval—could actually be a good thing, writes Claire McKenna in the April issue of Medical Design.
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The Type-90 Miniature Precision Air Pressure Regulator by ControlAir Inc, Amherst, NH, is designed to provide the highest level of regulation accuracy and repeatability available to valves and other automatic control equipment in a lightweight, compact housing.
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Sharpshooter vision sensors by Balluff, Florence, KY, include an ID version designed to read a large range of linear bar codes and 2D data matrix codes, as well as optical character verification (OCV). The Sharpshooter ID vision sensor can read more than 10 types of linear bar codes, including PDF417 and 2D data matrix codes.
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Empower PLM (Product Lifecycle Management) solution, version 5.0, by Omnify Software, Tewksbury, MA, features the following enhancements . . .
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Eliminate Tubing Misconnections
The SRC connector from Colder Products Company provides medical personnel with a tubing connector that is designed to eliminate potential misconnections that can occur with luer fittings.
www.colder.com/smallbore
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
Bishop-Wisecarver Corporation A manual brake is now available for compact UtiliTrak® linear guides -- a simple two-component assembly solution ideal for confined spaces in medical applications.
www.bwc.com
Phillips Plastics Corporation®
Medical OEM projects often require more that a custom part or a vendor with limited services. Learn more about the engineering services, materials support, clean rooms, quality control, packaging, sterilization, manufacturing technologies available from Phillips Plastics.
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