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Medical Edge January 10, 2012

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Medical Edge

News & Innovations for the Medical Device Community

January 10, 2012
Battelle report and MedicalDesign.com poll show more R&D spending in 2012
FDA-ABIA partnership targets safer, better-performing materials
iPhone glucose meter gains FDA approval
MRI-compatible ICDs
Legislation prompts positive responses from AdvaMed
Videoconferencing leak-detection consultations
Microcontroller for higher precision in portable medical applications
Compounds for catheters


Battelle report and MedicalDesign.com poll show more R&D spending in 2012

By Joe Jancsurak, Editor

R&D spending in the US is projected to rise 2.1% to $436 billion this year, according to data released by Battelle and reported on at www.WSJ.com. European R&D is forecast to grow by about 3.5% to $338.1 billion, while Asia's should increase 8.6% to $514.4 billion, according to the report.

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Articles


FDA-ABIA partnership targets safer, better-performing materials


FDA and Austen BioInnovation Institute in Akron (ABIA) have entered into a groundbreaking collaboration to support and develop regulatory science for the safe and effective use of biomaterials in medical devices.

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Stainless Steel Retaining Rings From Stock
Smalley has over 6,000 Spirolox® Retaining Rings in 302 and 316 stainless steel from stock in 1/4" to 16" diameters. Specials can manufactured from .200" to 120". Smalley's manufacturing process allows for the economical production of stainless steel retaining rings. Spiral type retaining rings are interchangeable with standard snap ring grooves and have No Ears To Interfere® with the assembly. Free samples are available of stock parts to test in your application. www.smalleymedical.com

iPhone glucose meter gains FDA approval


The iBGStar blood glucometer uses the Apple iPhone and iPod as a visualization tool to keep track of glucose readings, carbohydrate and insulin intake, and exercise. The device also can be used independently to take readings, and data are transformed to the iPhone once the two are connected again. Test results are color-coded so that high- and low-blood glucose results can be more easily identified. This application can be downloaded for free from the Apple Store.

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MRI-compatible ICDs


Lumax 740 implantable cardiac defibrillators by Biotronik are the first ICDs eligible for use with magnetic resonance imaging (MRI). The devices include an MR conditional feature and extended longevities up to 11 years.

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Legislation prompts positive responses from AdvaMed


New legislation introduced by Sen. Scott Brown (R-Mass.) to improve the de novo classification process for medical technology received kudos from AdvaMed as did the “Medical Device Patient Safety Act” by Sens. Grassley (R-Iowa), Kohl (D-Wis.), and Blumenthal (D-Conn.).

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New Products


Videoconferencing leak-detection consultations


Medical device and biotechnology product manufacturers seeking best match leak test solutions can now opt for no-cost videoconferencing consultations by link to Uson.

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Microcontroller for higher precision in portable medical applications


The F563x and F663x microcontrollers by Texas Instruments Inc (TI) are for portable measurement applications, including blood glucose meters, pulse oximeters, blood pressure monitors, electrocardiograms (ECG), activity monitors, and sensor hubs.

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Compounds for catheters


MEVOPUR masterbatches and compounds by Clariant provide catheter manufacturers with options for improving the functionality, visualization, and performance of their devices while meeting US and EU regulations. The compounds are available as single or as combination of additives using polymer specific carriers in a range of medically approved plastics.

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Featured Links


Minnetronix®...Thinking Medical Systems™
Minnetronix provides award-winning product design, development, manufacturing, and remote medical device monitoring services to the medical device and life science marketplaces. Minnetronix successfully incorporates custom electronic, mechanical and software engineering into finished Class II & III devices and systems such as cardiovascular and monitoring systems, therapeutic and implantable devices, and diagnostic instruments. ISO 13485 and FDA registered. www.minnetronix.com

Lowell: Experts in Close Tolerance Part Manufacturing to .00001
Lowell machines and tests our finished components and assemblies down to the submicron level. Our Leitz PMM and Brown & Sharpe CMM are tended robotically in a climate-controlled environment. ISO 9001:2000 and 13485:2003.
www.lowellinc.com/medical.php

Document translation: How to maximize accuracy and lower costs
International Language Services meets your standards for accuracy and expertise. Download our new white paper: “How to leverage translations to save time and cost.”

Boker's 2012 Washers Catalog
Boker's complimentary 2012 Washer Catalog offers more than 26,000 non-standard flat washer sizes available. The numerous outside/inside diameters, various thicknesses and over 2,000 materials provide endless possibilities. ISO 9001:2008 Registered
www.bokers.com/mee

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