Search Results for 'safety'

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• Surgical | Testing
  

  Medical Robots: Assessing Safety and Performance in a Growing Field

  Be aware of potential hazards robots may present and testing options to address them.

  Online Exclusives Bill Stearns, Associate Senior Engineer, Intertek 04.17.20
  

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  FDA Offers Coronavirus Update Regarding Product Safety

  The agency outlines the steps it will take to ensure the quality of foreign products.

  U.S. Food and Drug Administration 02.25.20
  

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  Mike on Medtech: Safety and Performance Based 510(k)

  Mike Drues and Sean Fenske discuss an “abbreviated” 510(k) option for specific, well-understood devices that doesn’t use a predicate.

  Sean Fenske, Editor-in-Chief 12.05.19
  

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• R&D & Design | Software & IT | Testing
  

  Transformative Testing: Addressing Patient Safety and Cybersecurity

  With changing regulatory landscapes and requirements, testing providers are being asked to do more in terms of ensuring the safety of medical devices.

  Mark Crawford, Contributing Writer 03.07.19
  

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• Surgical
  

  Bayer & FDA Expand Essure Postmarket Safety Study by Two Years

  Women in the study will be followed for five years, rather than the three years that was initially required.

  Scott Gottlieb, M.D., Commissioner, U.S. Food and Drug Administration 01.02.19
  

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• Surgical
  

  FDA Updates Medical Device Safety Action Plan to Enhance Post-Market Safety

  The agency aims to enhance medical device safety net and focus on several women's health devices.

  Scott Gottlieb M.D., Commissioner; Jeff Shuren M.D., Director of the Center for Devices and Radiological Health, U.S. Food and Drug Administration 11.21.18
  

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  Ten-Year Clinical Study Data Highlight Safety of MENTOR MemoryShape Gel Breast Implants

  Latest data show product safety and effectiveness in primary and revision augmentation and reconstruction patients.

  Johnson & Johnson 03.12.18
  

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• Cardiovascular | Diagnostics | Digital Health | Neurological | Patient Monitoring | Surgical | Testing
  

  In Pursuit of Device Safety or a Call for Whistleblowers?

  Late last year, Jeffrey Shuren, M.D., J.D., the U.S. Food and Drug Administration’s (FDA) director of the Center for Devices and Radiological Health, penned a blog for the FDA Voice (http://bit.ly/mpo031750) regarding the coordination between t…

  Sean Fenske, Editor 03.07.17
  

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• Smiths Medical Launches EDGE Safety Device on Arterial Blood Sampling Syringes in Europe

  One-handed safety activation device helps protect against potential needle stick injuries.

  12.29.14
  

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• R&D & Design

  Covidien Launches Improved Magellan Safety Hypodermic Needle

  New design gives clinicians more control

  Editor 12.03.08
  

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