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Tag: Medical Devices

22
Sep, 2016
medical device tracking

Medical Device Tracking IDs Could Save Lives If Hospitals Could Use Them

  • By
  • Andrew Steinberg
  • |
  • FDA News & Recalls
  • |
  • 1 Comments

Nine years ago, Congress passed an important piece of legislation requiring unique medical device identifying numbers on all medical devices. The law requires manufacturers to label each medical device,...

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12
Aug, 2016
fda standards

FDA Trying To Balance Between Premarket Data and Postmarket Requirements

  • By
  • Andrew Steinberg
  • |
  • FDA News & Recalls
  • |
  • 0 Comments

The FDA’s Center for Devices and Radiological Health (CDRH) has been incredibly busy lately. Earlier this week, the CDRH announced the completion of a project to analyze past medical...

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11
Aug, 2016
FDA

When Should Medical Devices Be Re-Approved?

  • By
  • Andrew Steinberg
  • |
  • FDA News & Recalls
  • |
  • 0 Comments

What does a device manufacturer do when it wants to make changes to its products? Before now, that was unclear; but, the FDA issued a draft guidance that aims...

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02
Aug, 2016
Medical Device Applications

FDA Reduces Fees For New Medical Device Applications

  • By
  • Andrew Steinberg
  • |
  • FDA News & Recalls
  • |
  • 0 Comments

The U.S. Food and Drug Administration (FDA) recently announced a reduction in fees for new medical device applications. The FDA hopes reducing the cost of applications will help encourage...

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26
Jul, 2016
3D printed medical devices

DePuy and J&J Eager To Jump Into 3D Printed Medical Devices

  • By
  • Andrew Steinberg
  • |
  • Drug & Device Manufacturers
  • |
  • 0 Comments

One of the quickly emerging fields in medical innovation is 3D printing, and DePuy Orthopedics (a subsidiary of Johnson & Johnson) recently announced a partnership with 3D printing giant...

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06
Jul, 2016
brexit

Brexit Will Cause Uncertainty In The Medical Device Industry

  • By
  • Andrew Steinberg
  • |
  • Drug & Device Manufacturers
  • |
  • 0 Comments

The UK’s exit from the European Union has left many questions regarding how the country will conduct business with other European countries. For the medical device industry, this question...

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28
Jun, 2016
FDA

FDA Issues Draft Guidance on Medical Device Availability

  • By
  • Andrew Steinberg
  • |
  • FDA News & Recalls
  • |
  • 0 Comments

The Food and Drug Administration (FDA) has released a draft guidance on medical device availability, compliance, and enforcement. The draft guidance will help device manufacturers understand the process the...

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21
Jun, 2016
stomach pump

FDA Approves Stomach Pump for Obesity

  • By
  • Andrew Steinberg
  • |
  • Defective Medical Devices
  • |
  • 0 Comments

The Food and Drug Administration (FDA) has approved an unusual device that is designed to remove food directly from the stomach and deposit it into the toilet. While the...

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07
Jun, 2016
essure

Canada Warns of Essure Device

  • By
  • Andrew Steinberg
  • |
  • FDA News & Recalls
  • |
  • 0 Comments

Health Canada released a statement warning physicians and patients of the dangerous complications associated with Essure, a permanent birth control implant. The device, manufactured by Bayer A.G., has led...

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24
May, 2016
medical devices

Should Women Be More Wary of Medical Devices Than Men?

  • By
  • Andrew Steinberg
  • |
  • Defective Medical Devices
  • |
  • 0 Comments

While the FDA has set strict guidelines for the approval of medical devices, a recent study from researchers at Northwestern University’s Feinberg School of Medicine found that several high-risk...

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