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Earl's View

Tag Archives: Medical device

ASME DC | Journal of Medical Devices | Battery-Less Wireless Instrumented Knee Implant

April 7, 2013

ASME DC | Journal of Medical Devices | Battery-Less Wireless Instrumented Knee Implant. Battery-Less Wireless Instrumented Knee Implant J. Holmberg, L. …

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FDA cracks down on all-metal hip replacements

March 4, 2013

http://news.consumerreports.org/health/2013/01/fda-cracks-down-on-all-metal-hip-replacements.html FDA cracks down on all-metal hip replacements Manufacturers who want to keep selling all-metal hips will have to prove …

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Metal hip patients ‘need annual checks’ – Health News – Filey and Hunmanby Mercury

February 25, 2013

Metal hip patients ‘need annual checks’ – Health News – Filey and Hunmanby Mercury. Metal hip patients ‘need annual checks’ …

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Smith & Nephew Failure Warning for Birmingham Hip Implant

February 25, 2013

Smith & Nephew Failure Warning for Birmingham Hip Implant. Smith & Nephew Failure Warning for Birmingham Hip Implant September 27, …

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The Hip Replacement Case Shows Why Doctors Often Remain Silent – NYTimes.com

February 17, 2013

The Hip Replacement Case Shows Why Doctors Often Remain Silent – NYTimes.com. Doctors Who Don’t Speak Out By BARRY MEIER Published: …

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Patients victims of untested medical devices – SFGate

February 16, 2013

Patients victims of untested medical devices – SFGate. Patients victims of untested medical devices Victoria Colliver Updated 9:21 pm, Tuesday, February …

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What DePuy Orthopaedics Knew About Its All-Metal Hips – NYTimes.com

February 12, 2013

What DePuy Orthopaedics Knew About Its All-Metal Hips – NYTimes.com. EDITORIAL What a Company Knew About Its Metal Hips Published: …

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A Few New Year’s Wishes and Thoughts from one of the many MOM ‘Victims’!

January 8, 2013

A Few New Year’s Wishes and Thoughts from one of the many MOM ‘Victims’! Well, 2013 is finally here, the …

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Howard Comments: Layoffs: Medical device companies cut 7,000 jobs in 2012 | MassDevice

December 25, 2012

As was anticipated big layoffs from the medical device manufacturers; the BLAME or FINGER being pointed at the device tax to …

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Metal on Metal Expert Hip Resurfacing – Tom Joyce on device regulation | BMJ

December 9, 2012

Medical devices – Tom Joyce on device regulation | BMJ. Medical devices – Tom Joyce on device regulation The BMJ …

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What Happened to the FDA Request for More Hip Implant Studies? – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts

November 11, 2012

What Happened to the FDA Request for More Hip Implant Studies? – Florida Mass Tort Attorneys, Lawyers | Searcy Mass …

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Howard Says – And We Agree – Come Clean Smith & Nephew

November 1, 2012

It is time for Smith and Nephew to be realistic and honest, afterall in their code of ehtics the safety …

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Faulty medical implants investigation: Patients treated ‘like guinea pigs’ – Telegraph

October 26, 2012

Faulty medical implants investigation: Patients treated ‘like guinea pigs’ – Telegraph. Faulty medical implants investigation: Patients treated ‘like guinea pigs’ …

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Faulty medical implants investigation: Patients at risk from flaws in medical device rules, admit EU chiefs – Telegraph

October 26, 2012

Faulty medical implants investigation: Patients at risk from flaws in medical device rules, admit EU chiefs – Telegraph. Faulty medical …

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The FDA is there to protect patients? Bullsh*t …

October 11, 2012

The FDA is there to protect patients? Bullsht | MassDevice – Medical Device Industry News. The FDA is there to …

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Hundreds of NZ hip replacements are faulty – National – NZ Herald News

October 4, 2012

Hundreds of NZ hip replacements are faulty – National – NZ Herald News. Hundreds of NZ hip replacements are faulty …

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Shake-up of EU medical device regulations shocks industry

October 3, 2012

Shake-up of EU medical device regulations shocks industry. Source: http://www.buildingbetterhealthcare.co.uk/news/article_page/Shakeup_of_EU_medical_device_regulations_shocks_industry/81250  Shake-up of EU medical device regulations shocks industry Medical Devices | Market Information | Regulatory | …

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Medical Devices Vulnerable to Hacking Need Oversight – Businessweek

September 29, 2012

Medical Devices Vulnerable to Hacking Need Oversight – Businessweek. Bloomberg News Medical Devices Vulnerable to Hacking Need Oversight By Jordan …

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Australia – Sky News: Hip replacements should be checked – TGA

September 22, 2012

Sky News: Hip replacements should be checked – TGA. Hip replacements should be checked – TGA Updated: 08:07, Friday September …

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Plaintiffs look to depose new Johnson & Johnson CEO Gorsky in DePuy ASR lawsuit | MassDevice – Medical Device Industry News

September 15, 2012

Plaintiffs look to depose new Johnson & Johnson CEO Gorsky in DePuy ASR lawsuit | MassDevice – Medical Device Industry …

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New Zealand – Medical Devices – Medsafe Guidelines for MoM hips

September 14, 2012

Medical Devices. Management of Patients with Metal on Metal Hip Implants. Medsafe and the New Zealand Orthopaedic Association (NZOA) (www.NZOA.org.nz) support …

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South Africa – Sixty sue for dud hip joints – Crime & Courts | IOL News | IOL.co.za

September 14, 2012

Sixty sue for dud hip joints – Crime & Courts | IOL News | IOL.co.za. Sixty sue for dud hip …

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Neurosurgeon’s Conflict With Spine Device Company Sheds More Light on FDA Approval Process

September 7, 2012

Neurosurgeon’s Conflict With Spine Device Company Sheds More Light on FDA Approval Process. Neurosurgeon’s Conflict With Spine Device Company Sheds …

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Revision of hip resurfacing arthroplasty with a bone-conserving short-stem implant

August 30, 2012

Journal of Medical Case Reports | Abstract | Revision of hip resurfacing arthroplasty with a bone-conserving short-stem implant: a case …

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» Medical device units recalled in Q2 represent eight-quarter high | MedCity News

August 30, 2012

» Medical device units recalled in Q2 represent eight-quarter high | MedCity News. Medical device units recalled in Q2 represent …

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FDA Aims To Smooth Premarket Review process | Bloomberg BNA

August 24, 2012

FDA Aims To Smooth Premarket Review process | Bloomberg BNA. Wednesday, August 22, 2012 FDA Aims To Smooth Premarket Review …

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Cry from the Heart – Where is Mr Smith & his Nephew?

August 20, 2012

Recent comment published on Earl‘sview that deserves more notice: Does Smith and Nephew not hear the cries from victims of …

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Pre Market Approval – Why does the Law shelter Smith & Nephew & others like them?

August 20, 2012

Premarket Approval by the FDA – why do we lose out? Reading this recent law review article by Professor Ralph Hall, …

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Smith & Nephew R3 Hip Liner Recall Lawyer – Hip Implant Lawsuit Attorney

August 19, 2012

Smith & Nephew R3 Hip Liner Recall Lawyer – Hip Implant Lawsuit Attorney. The Smith & Nephew R3 Hip Implant …

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Dems urge FDA to boost medtech recall database | MassDevice.com

August 19, 2012

Dems urge FDA to boost medtech recall database | MassDevice.com On Call | MassDevice – Medical Device Industry News. Dems …

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Loophole in FDA’s Approval Process for Medical Devices Prompts Letter from Congress – Forbes

August 18, 2012

Loophole in FDA’s Approval Process for Medical Devices Prompts Letter from Congress – Forbes. Loophole in FDA’s Approval Process for …

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Rottenstein Law Group Reports on Research Paper Concluding FDA’s Medical Device Approval Process Needs Reform

August 18, 2012

Rottenstein Law Group Reports on Research Paper Concluding FDA’s Medical Device Approval Process Needs Reform. Rottenstein Law Group Reports on …

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The US Medical Device Market is a Dinosaur – Mike comments

August 14, 2012

The medical device industry is a dinosaur. Sales people getting paid hundreds of thousands who don’t really know anything about …

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Is the US Medical Device Industry Heading the Way of the Dinosaur?

July 21, 2012

Plastics News – Report calls for changes in medical device sector. Report calls for changes in medical device sector By …

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Henry Miller: FDA has device makers looking outside U.S. | fda, device, medical – Opinion – The Orange County Register

July 21, 2012

Henry Miller: FDA has device makers looking outside U.S. | fda, device, medical – Opinion – The Orange County Register. …

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FDA – Overview of Medical Device Regulation > Information about MDUFA III

July 15, 2012

Overview of Medical Device Regulation > Information about MDUFA III. Information about MDUFA III Congress recently authorized the Medical Device …

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Medical Device ID Proposal Unveiled – GovInfoSecurity

July 15, 2012

Medical Device ID Proposal Unveiled – GovInfoSecurity. Medical Device ID Proposal Unveiled FDA Would Create Database of Information By Marianne …

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FDA to help medical device sales with expanded pre-market feedback program

July 15, 2012

FDA to help medical device sales with expanded pre-market feedback program. FDA to help medical device sales with expanded pre-market …

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As lawsuits climb, J&J may have new hip trauma – Pinnacle metal-on-metal hip system has nearly 1,600 lawsuits pending

July 14, 2012

As lawsuits climb, J&J may have new hip trauma | Smart Business. As lawsuits climb, J&J may have new hip …

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Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions

July 14, 2012

Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions. FDA NEWS RELEASE For Immediate Release: …

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FDA to guide device makers on marketing application – chicagotribune.com

July 14, 2012

FDA to guide device makers on marketing application – chicagotribune.com. FDA to guide device makers on marketing application Ads by …

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About Metal-on-Metal Hip Implants

July 14, 2012

About Metal-on-Metal Hip Implants. About Metal-on-Metal Hip Implants If you or your loved one has endured a MoM hip implant …

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FDA – User Fees for Medical Devices: Third Time Lucky?

July 8, 2012

User Fees for Medical Devices: Third Time Lucky? John R. Graham, Director, Health Care Studies Congress recently passed, almost unanimously, S.3187, …

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FDA Proposes New Rule That Would Require Medical Devices Such as Surgical Mesh to Carry Unique Device Identifier

July 8, 2012

FDA Proposes New Rule That Would Require Medical Devices Such as Surgical Mesh to Carry Unique Device Identifier. FDA Proposes …

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Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 1

July 8, 2012

June 27 2012 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 1 Click the link below …

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FDA releases proposed UDI rule; reaction generally positive

July 8, 2012

FDA releases proposed UDI rule; reaction generally positive | Healthcare Finance News. July 06, 2012 | Rene Letourneau, Editor WASHINGTON …

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Governmental Oversight of Potentially Dangerous Medical Devices – US Politics Today

July 8, 2012

Governmental Oversight of Potentially Dangerous Medical Devices – US Politics Today. Governmental Oversight of Potentially Dangerous Medical Devices Public and …

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FDA Proposes Device ID Regulations for Medical Dev – TMD – Today’s Medical Developments

July 8, 2012

FDA Proposes Device ID Regulations for Medical Dev – TMD – Today’s Medical Developments. FDA Proposes Device ID Regulations for …

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Smith & Nephew BHR – Food and Drug Administration, HHS

July 8, 2012

http://www.gpo.gov/fdsys/pkg/CFR-2011-title21-vol8/pdf/CFR-2011-title21-vol8-sec888-5.pdf. PDF File: Food and Drug Administration, HHS CFR-2011-title21-vol8-sec888-5 Food and Drug Administration, HHS 513(f) of the act) into class III …

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FDA Defense of its Decision to Grant PMA to Smith & Nephew’s BHR…

July 7, 2012

FDA Defense of its Decision to Grant PMA to Smith & Nephew’s BHR… http://www.fda.gov/ohrms/dockets/dockets/05p0440/05p-0440-pdn0001-vol2.pdf. Dear Mr.  Roberts: Food and Drug …

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