Medical Device Industry News » medical-devices

Medical Device Animation – Short Demo

admin — Wed, 01 Feb 2012 17:13:40 +0000

Medical device samples from our animation studio including – Gamma Knife, Vascular Stent, CyberKnife, Stomach Stapling, Diabetes Pump, Bone Implant, Alpha Stim and ArmPort. See more at www.schoncreative.com

http://www.youtube.com/v/qArjzUwN0Qc?version=3&f=videos&app=youtube_gdata

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Medical Device Animation – Short Demo

Medical Device Summit – Supplier Controls & Quality Management Conference Panel Discussion Part I

admin — Mon, 30 Jan 2012 01:02:24 +0000

This 10 minute video is part I of a series of videos from a panel discussion from Medical Device Summit’s Supplier Controls & Quality Management Conference. Steve Niedleman, Moderator and Lead Quality System & Compliance Consultant leads a discussion on “Challenges in Change Control Requirements”. Rita Guzzetta of Medtronic address the importance of documentation even at what is perceived to be “low level changes. Mike Buffington of GE talks about what you must declare as a change and that you must also provide the vehicle enabling change communication. Joel Roth of Edwards Lifescience references how a Chinese sister company of one of their suppliers made a design change without notifying Edwards Lifescience and the consequence of that change. Finally a question from the audience focused on a centralized process system to assure that change notification works across suppliers with various divisions

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Medical Device Summit – Supplier Controls & Quality Management Conference Panel Discussion Part I

Kim Trautman at Medical Device Summit’s Suppler Controls & Quality Management Conference

admin — Fri, 27 Jan 2012 16:22:32 +0000

In this 5-minute video, Kim Trautman, FDA’s Medical Device International Quality Systems Expert, speaks with Sangita Viswanathan, Editor-in-Chief, Medical Device Summit, on managing internal suppliers; benchmarking; and tackling global supply chain challenges. Trautman, who has been recently named FDA’s Acting Associate Director-International Affairs asks the device sector to: 1. Pay attention to internal suppliers; “a supplier is a supplier even if they are part of the same corporate structure, and you still need soundproof terms of agreement under QSR;” 2. Look at some best practices followed by automotive, telecommunications and aerospace sectors for risk management and supplier controls, and adapt these for consistent, better quality results; and 3. Work with FDA which has number of initiatives for managing global supply chain integrity and quality, and have the assurances in place to understand your supplier, manage risk and ensure a good quality product.

http://www.youtube.com/v/-Hqe-assx28?version=3&f=videos&app=youtube_gdata

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Kim Trautman at Medical Device Summit’s Suppler Controls & Quality Management Conference

Tornier Announces 2011 Fourth Quarter and Full Year Conference Call

Fri, 27 Jan 2012 13:00:00 +0000

AMSTERDAM–(BUSINESS WIRE)–Tornier, N.V. (NASDAQ: TRNX), a global medical device company focused on providing surgical solutions to orthopaedic extremity specialists, announced today that it will report financial results for the three months and full year ended December 31, 2011, after the market close on Thursday, February 23, 2012. The Company also announced that Doug Kohrs, President and Chief Executive Officer, and Carmen Diersen, Chief Financial Officer, will host an investor conference ca

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Tornier Announces 2011 Fourth Quarter and Full Year Conference Call

The Ins And Outs Of The Aesthetics Market: An Interview With Steven H. Dayan, MD

admin — Wed, 25 Jan 2012 19:02:11 +0000

The effectiveness of a product is only one aspect of how well a device will succeed in the aesthetics market. In the following interview, Steven H. Dayan, MD, a noted Chicago plastic surgeon, tells Medtech Insight that manufacturers seeking to enter this space need to spend time on market research and fully understand where their products will be used and who will use them.

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The Ins And Outs Of The Aesthetics Market: An Interview With Steven H. Dayan, MD

Buyer Appetite Might Appeal To GI Device Investors

admin — Wed, 25 Jan 2012 18:46:57 +0000

A long-time darling of venture capital, the gastrointestinal sector has yet to meet expectation of VCs who wagered on technologies to treat gastroesophageal reflux disease, Barrett’s esophagus and even obesity. But some notable acquisitions, including Covidien’s purchase of privately held Barrx, may present a ray of hope for investors in GI companies.

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Buyer Appetite Might Appeal To GI Device Investors

DFINE Seeks Meaning Outside Of Spine

admin — Wed, 25 Jan 2012 18:36:26 +0000

Privately held DFINE Inc., a supplier of tools for treating vertebral compression fractures in the spine, is trying to reposition itself from being a spine company to an “interventionalist company” that provides tools necessary to interventional radiologists, neuroradiologists, and oncologists.

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DFINE Seeks Meaning Outside Of Spine

ZELTIQ® Initiates Patent Infringement Lawsuit Against Clinipro

Wed, 25 Jan 2012 12:00:00 +0000

PLEASANTON, Calif.–(BUSINESS WIRE)–ZELTIQ Aesthetics, Inc. (Nasdaq: ZLTQ), a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology platform, and the charitable trust of Massachusetts General Hospital (MGH) initiated a patient infringement lawsuit in France against Clinipro and its French representative on December 23, 2011. ZELTIQ is a global medical device company that has developed an innovative, non-invasive, cl

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ZELTIQ® Initiates Patent Infringement Lawsuit Against Clinipro

510(k) Guidance Footnote May Signal Greater FDA Oversight Of Preclinical Testing

admin — Tue, 24 Jan 2012 16:48:20 +0000

Device industry experts say a seemingly minor footnote to the recent 510(k) program draft guidance could create a new requirement for nonclinical studies.

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510(k) Guidance Footnote May Signal Greater FDA Oversight Of Preclinical Testing

Research and Markets: US Medical Imaging Market Outlook and Opportunities Report Provides Forecasts up to 2016

Fri, 20 Jan 2012 17:54:00 +0000

DUBLIN–(BUSINESS WIRE)–Research and Markets(http://www.researchandmarkets.com/research/224e83/us_medical_imaging) has announced the addition of the “US Medical Imaging Market Outlook and Opportunities” report to their offering. The Market Intelligence report provides critical market data for US medical imaging devices market and its product categories. The data includes market size in terms of value and volume; average selling price for each product type, growth trends and market shares of com

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Research and Markets: US Medical Imaging Market Outlook and Opportunities Report Provides Forecasts up to 2016