Half of decade-old metal hip implants defective – Life & Style – NZ Herald News
Half of decade-old metal hip implants defective – Life & Style – NZ Herald News. Half of decade-old metal hip …
Tag Archives: Medical device
Medical device firms push to comply with new FDA rules
Source & full article: Medical device firms push to comply with new FDA rules. Medical device firms push to comply with …
How does the FDA ‘approve’ medical products? – Medical News Today
Source article for full text: How does the FDA ‘approve’ medical products? – Medical News Today. How does the FDA ‘approve’ …
Biomet reaches $56 million settlement over faulty hip replacements | Reuters
Source: Biomet reaches $56 million settlement over faulty hip replacements | Reuters. Biomet reaches $56 million settlement over faulty hip replacements …
The Myth of the Medical-Device Tax
The Myth of the Medical-Device Tax WASHINGTON — IN the last few days of negotiations in Congress, repeal of the …
Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants
Johnson & Johnson Said to Agree to $4 Billion Settlement Over Hip Implants Andrew Testa for The New York Times …
Consumer Reports Urges a Lemon Law For Joint Replacements
Consumer Reports Urges a Lemon Law For Joint Replacements by Christy Rakoczy, a J.D. Manufacturers of hip and knee replacement …
FiDA Failed Implant Device Alliance: Exposed! : Secret Medical Device Payments to Doctors
FiDA Failed Implant Device Alliance: Exposed! : Secret Medical Device Payments to Doctors. Exposed! : Secret Medical Device Payments to …
ASME DC | Journal of Medical Devices | Battery-Less Wireless Instrumented Knee Implant
ASME DC | Journal of Medical Devices | Battery-Less Wireless Instrumented Knee Implant. Battery-Less Wireless Instrumented Knee Implant J. Holmberg, L. …
FDA cracks down on all-metal hip replacements
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 …
Metal hip patients ‘need annual checks’ – Health News – Filey and Hunmanby Mercury
Metal hip patients ‘need annual checks’ – Health News – Filey and Hunmanby Mercury. Metal hip patients ‘need annual checks’ …
Smith & Nephew Failure Warning for Birmingham Hip Implant
Smith & Nephew Failure Warning for Birmingham Hip Implant. Smith & Nephew Failure Warning for Birmingham Hip Implant September 27, …
The Hip Replacement Case Shows Why Doctors Often Remain Silent – NYTimes.com
The Hip Replacement Case Shows Why Doctors Often Remain Silent – NYTimes.com. Doctors Who Don’t Speak Out By BARRY MEIER Published: …
Patients victims of untested medical devices – SFGate
Patients victims of untested medical devices – SFGate. Patients victims of untested medical devices Victoria Colliver Updated 9:21 pm, Tuesday, February …
What DePuy Orthopaedics Knew About Its All-Metal Hips – NYTimes.com
What DePuy Orthopaedics Knew About Its All-Metal Hips – NYTimes.com. EDITORIAL What a Company Knew About Its Metal Hips Published: …
A Few New Year’s Wishes and Thoughts from one of the many MOM ‘Victims’!
A Few New Year’s Wishes and Thoughts from one of the many MOM ‘Victims’! Well, 2013 is finally here, the …
Howard Comments: Layoffs: Medical device companies cut 7,000 jobs in 2012 | MassDevice
As was anticipated big layoffs from the medical device manufacturers; the BLAME or FINGER being pointed at the device tax to …
Metal on Metal Expert Hip Resurfacing – Tom Joyce on device regulation | BMJ
Medical devices – Tom Joyce on device regulation | BMJ. Medical devices – Tom Joyce on device regulation The BMJ …
What Happened to the FDA Request for More Hip Implant Studies? – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts
What Happened to the FDA Request for More Hip Implant Studies? – Florida Mass Tort Attorneys, Lawyers | Searcy Mass …
Howard Says – And We Agree – Come Clean Smith & Nephew
It is time for Smith and Nephew to be realistic and honest, afterall in their code of ehtics the safety …
Faulty medical implants investigation: Patients treated ‘like guinea pigs’ – Telegraph
Faulty medical implants investigation: Patients treated ‘like guinea pigs’ – Telegraph. Faulty medical implants investigation: Patients treated ‘like guinea pigs’ …
Faulty medical implants investigation: Patients at risk from flaws in medical device rules, admit EU chiefs – Telegraph
Faulty medical implants investigation: Patients at risk from flaws in medical device rules, admit EU chiefs – Telegraph. Faulty medical …
The FDA is there to protect patients? Bullsh*t …
The FDA is there to protect patients? Bullsht | MassDevice – Medical Device Industry News. The FDA is there to …
Hundreds of NZ hip replacements are faulty – National – NZ Herald News
Hundreds of NZ hip replacements are faulty – National – NZ Herald News. Hundreds of NZ hip replacements are faulty …
Shake-up of EU medical device regulations shocks industry
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 | …
Medical Devices Vulnerable to Hacking Need Oversight – Businessweek
Medical Devices Vulnerable to Hacking Need Oversight – Businessweek. Bloomberg News Medical Devices Vulnerable to Hacking Need Oversight By Jordan …
Australia – Sky News: Hip replacements should be checked – TGA
Sky News: Hip replacements should be checked – TGA. Hip replacements should be checked – TGA Updated: 08:07, Friday September …
Plaintiffs look to depose new Johnson & Johnson CEO Gorsky in DePuy ASR lawsuit | MassDevice – Medical Device Industry News
Plaintiffs look to depose new Johnson & Johnson CEO Gorsky in DePuy ASR lawsuit | MassDevice – Medical Device Industry …
New Zealand – Medical Devices – Medsafe Guidelines for MoM hips
Medical Devices. Management of Patients with Metal on Metal Hip Implants. Medsafe and the New Zealand Orthopaedic Association (NZOA) (www.NZOA.org.nz) support …
South Africa – Sixty sue for dud hip joints – Crime & Courts | IOL News | IOL.co.za
Sixty sue for dud hip joints – Crime & Courts | IOL News | IOL.co.za. Sixty sue for dud hip …
Neurosurgeon’s Conflict With Spine Device Company Sheds More Light on FDA Approval Process
Neurosurgeon’s Conflict With Spine Device Company Sheds More Light on FDA Approval Process. Neurosurgeon’s Conflict With Spine Device Company Sheds …
Revision of hip resurfacing arthroplasty with a bone-conserving short-stem implant
Journal of Medical Case Reports | Abstract | Revision of hip resurfacing arthroplasty with a bone-conserving short-stem implant: a case …
» Medical device units recalled in Q2 represent eight-quarter high | MedCity News
» Medical device units recalled in Q2 represent eight-quarter high | MedCity News. Medical device units recalled in Q2 represent …
FDA Aims To Smooth Premarket Review process | Bloomberg BNA
FDA Aims To Smooth Premarket Review process | Bloomberg BNA. Wednesday, August 22, 2012 FDA Aims To Smooth Premarket Review …
Cry from the Heart – Where is Mr Smith & his Nephew?
Recent comment published on Earl‘sview that deserves more notice: Does Smith and Nephew not hear the cries from victims of …
Pre Market Approval – Why does the Law shelter Smith & Nephew & others like them?
Premarket Approval by the FDA – why do we lose out? Reading this recent law review article by Professor Ralph Hall, …
Smith & Nephew R3 Hip Liner Recall Lawyer – Hip Implant Lawsuit Attorney
Smith & Nephew R3 Hip Liner Recall Lawyer – Hip Implant Lawsuit Attorney. The Smith & Nephew R3 Hip Implant …
Dems urge FDA to boost medtech recall database | MassDevice.com
Dems urge FDA to boost medtech recall database | MassDevice.com On Call | MassDevice – Medical Device Industry News. Dems …
Loophole in FDA’s Approval Process for Medical Devices Prompts Letter from Congress – Forbes
Loophole in FDA’s Approval Process for Medical Devices Prompts Letter from Congress – Forbes. Loophole in FDA’s Approval Process for …
Rottenstein Law Group Reports on Research Paper Concluding FDA’s Medical Device Approval Process Needs Reform
Rottenstein Law Group Reports on Research Paper Concluding FDA’s Medical Device Approval Process Needs Reform. Rottenstein Law Group Reports on …
The US Medical Device Market is a Dinosaur – Mike comments
The medical device industry is a dinosaur. Sales people getting paid hundreds of thousands who don’t really know anything about …
Is the US Medical Device Industry Heading the Way of the Dinosaur?
Plastics News – Report calls for changes in medical device sector. Report calls for changes in medical device sector By …
Henry Miller: FDA has device makers looking outside U.S. | fda, device, medical – Opinion – The Orange County Register
Henry Miller: FDA has device makers looking outside U.S. | fda, device, medical – Opinion – The Orange County Register. …
FDA – Overview of Medical Device Regulation > Information about MDUFA III
Overview of Medical Device Regulation > Information about MDUFA III. Information about MDUFA III Congress recently authorized the Medical Device …
Medical Device ID Proposal Unveiled – GovInfoSecurity
Medical Device ID Proposal Unveiled – GovInfoSecurity. Medical Device ID Proposal Unveiled FDA Would Create Database of Information By Marianne …
FDA to help medical device sales with expanded pre-market feedback program
FDA to help medical device sales with expanded pre-market feedback program. FDA to help medical device sales with expanded pre-market …
As lawsuits climb, J&J may have new hip trauma – Pinnacle metal-on-metal hip system has nearly 1,600 lawsuits pending
As lawsuits climb, J&J may have new hip trauma | Smart Business. As lawsuits climb, J&J may have new hip …
Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions
Press Announcements > FDA outlines plans to provide earlier feedback on device product submissions. FDA NEWS RELEASE For Immediate Release: …
FDA to guide device makers on marketing application – chicagotribune.com
FDA to guide device makers on marketing application – chicagotribune.com. FDA to guide device makers on marketing application Ads by …
About Metal-on-Metal Hip Implants
About Metal-on-Metal Hip Implants. About Metal-on-Metal Hip Implants If you or your loved one has endured a MoM hip implant …
FDA – User Fees for Medical Devices: Third Time Lucky?
User Fees for Medical Devices: Third Time Lucky? John R. Graham, Director, Health Care Studies Congress recently passed, almost unanimously, S.3187, …
FDA Proposes New Rule That Would Require Medical Devices Such as Surgical Mesh to Carry Unique Device Identifier
FDA Proposes New Rule That Would Require Medical Devices Such as Surgical Mesh to Carry Unique Device Identifier. FDA Proposes …
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 1
June 27 2012 Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Day 1 Click the link below …
FDA releases proposed UDI rule; reaction generally positive
FDA releases proposed UDI rule; reaction generally positive | Healthcare Finance News. July 06, 2012 | Rene Letourneau, Editor WASHINGTON …
Governmental Oversight of Potentially Dangerous Medical Devices – US Politics Today
Governmental Oversight of Potentially Dangerous Medical Devices – US Politics Today. Governmental Oversight of Potentially Dangerous Medical Devices Public and …
FDA Proposes Device ID Regulations for Medical Dev – TMD – Today’s Medical Developments
FDA Proposes Device ID Regulations for Medical Dev – TMD – Today’s Medical Developments. FDA Proposes Device ID Regulations for …
Smith & Nephew BHR – Food and Drug Administration, HHS
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 …
FDA Defense of its Decision to Grant PMA to Smith & Nephew’s BHR…
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 …
Wright Medical’s Response to Smith & Nephew’s Response to WMT request to Deny BHR PMA
Wright Medical’s Response to Smith & Nephew‘s Response to WMT request to Deny BHR PMA http://www.fda.gov/ohrms/dockets/dockets/05p0440/05p-0440-rc00001-01-vol3.pdf. Click the above link …
Premarket Approval (PMA) Database – BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
MDRWeb Medical Device Register On-line from Canon Communications, LLC. Premarket Approval (PMA) Database Premarket Approval (PMA) Database Trade Name: BIRMINGHAM …
P040033: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM by SMITH&NEPHEW ORTHOPAEDICS – FDAzilla Devices
P040033: BIRMINGHAM HIP RESURFACING (BHR) SYSTEM by SMITH&NEPHEW ORTHOPAEDICS – FDAzilla Devices. PMA Application: P040033 S017 (Most recently approved supplement) Attribute …
Post-Approval Studies for Smith & Nephew BHR – NOT USEFUL
Post-Approval Studies for Smith & Nephew BHR – NOT USEFUL Post-Approval Studies. Post-Approval Studies FDA Home Medical Devices Databases – …
New FDA guidance on considerations used in device approval
New FDA guidance on considerations used in device approval. New FDA Guidance used in Device Approval THURSDAY, MARCH 29. 2012; FDA …
The US Drug Watchdog Now Urges Plaintiffs Law Firms Worldwide To Contact Them About A Possible International Effort To Help Victims Of Defective Drugs Or Medical Devices – SFGate
The US Drug Watchdog Now Urges Plaintiffs Law Firms Worldwide To Contact Them About A Possible International Effort To Help …
Medical Device « The Senate Passes Unparalleled Medical Device User Fee Act
Medical Device « DePuy Recall Blog. The Senate Passes Unparalleled Medical Device User Fee Act When the Senate passed the resolution …
Press release: MHRA tells surgeons to stop using R3 metal cup liner and extends patient monitoring advice : MHRA
MHRA tells surgeons to stop using R3 metal cup liner and extends patient monitoring advice Contact: Press Office 020 3080 …
FDA PMA – how this hides the guilty and stops The Damaged and Suffering from getting Justice – Smith & Nephew
Smith & Nephew BHR – How can a device manufacturer be denied by the FDA on a 3/2 vote in …
Comment Example: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee
I thought it might be helpful to show what I sent in electronically in advance of the above referenced meeting, …
Thanks from Howard
Thank you Earl and your blog again and thank you folks that have contacted me re: attorneys. I will let …
FDA rule clears medical devices without human testing | devices, – News – The Orange County Register
FDA rule clears medical devices without human testing | devices, – News – The Orange County Register. Published: May 18, …
Zimmer Durom Cup Hip Implant – Waters & Kraus
Zimmer Durom Cup Hip Implant – Waters & Kraus. Zimmer Durom Cup Hip Implant We protect the interests of those …
Are Metal-on-Metal Hip Implants Tied to Increased Cancer Risk? Part Three: Specific Cancer Risks Post Metal-on-Metal Hip Implant
Are Metal-on-Metal Hip Implants Tied to Increased Cancer Risk? Part Three: Specific Cancer Risks Post Metal-on-Metal Hip Implant. Are Metal-on-Metal …
Howard poses some important questions….
I am looking for a real answer to a real question- if the Catholic Church was held accountable for their …
Recalls of Medical Devices and Consumer Products Rise to Kick-Off the New Year | ExpertRECALL | Recall Management, Product Retrieval, Recall Logistics
Recalls of Medical Devices and Consumer Products Rise to Kick-Off the New Year Mike Rozembajgier 05-14-2012 By Mike RozembajgierMedical device …
Corporate Whistle Blower Center Launches New Initiative to Go After a Very Corrupt US Medical Device Industry and Urges Insiders to Step Forward for Possible Huge Rewards
Corporate Whistle Blower Center Launches New Initiative to Go After a Very Corrupt US Medical Device Industry and Urges Insiders …
German engineers develop a non-metal hip implant for long-term use | MassDevice.com On Call | MassDevice – Medical Device Industry News
German engineers develop a non-metal hip implant for long-term use | MassDevice.com On Call | MassDevice – Medical Device Industry …
Hip Replacement Crisis in Europe Causes Demand for Medical Device Registry
Hip Replacement Crisis in Europe Causes Demand for Medical Device Registry. The global medical crises of dangerous metal-on-metal hip implants …
Metal-on-Metal Hip Implants – Advisories, Warnings & Recalls for the public
Metal-on-Metal Hip Implants – Advisories, Warnings & Recalls for the public. Public Communication – Health Canada Issued Important Safety Information …
Medical Implant Recalls Raises Questions about 510K Review Process. | U.S. PIRG
Medical Implant Recalls Raises Questions about 510K Review Process. | U.S. PIRG. Medical Implant Recalls Raises Questions about 510K Review …
MoM Hip Victim Stories to the Orthopedic and Rehab Devices Panel of Med. Devices Advisory Commitee
I just want to emphasize how important it is for as many of us as possible to send in our …
June 27-28, 2012: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0293] Orthopaedic and Rehabilitation Devices Panel of the …
Howard shares more views
Medical News: has 2 articles, reiteration, (daily.headlines@medpagetoday.com). People must learn about this or nothing will happen other than the medical …
What is the Status of Biomet Metal on Metal Hip Replacements | PA Law Blogs
What is the Status of Biomet Metal on Metal Hip Replacements | PA Law Blogs. What is the Status of …
Senators Introduce Safe Medical Devices Act
Senators Introduce Safe Medical Devices Act. Senators Introduce ‘Safe Medical Devices Act’ A bipartisan group of U.S. senators is pushing …
FDA Workers Say Outsiders Influence Medical Device Decisions | Patrick Malone & Associates P.C. | DC Injury Lawyers – JDSupra
FDA Workers Say Outsiders Influence Medical Device Decisions | Patrick Malone & Associates P.C. | DC Injury Lawyers – JDSupra. …
Consumer Reports Poll: Consumers Support More Medical Device Oversight
Consumer Reports Poll: Consumers Support More Medical Device Oversight Posted: 20 Mar 2012 07:38 AM PDT CONSUMERS UNION NEWS RELEASE …
House of Representatives to take away Patients rights to Sue
March 16, 2012 Next week, the U.S. House of Representatives will be voting on H.R. No. 5, which has been …
US Drug Watchdog Warns There Could 100,000s of Failed Metal on Metal Hip Implants Involving US Hip Implant Recipients and the DePuy ASR was Just the Starting Point – Yahoo! News
US Drug Watchdog Warns There Could 100,000s of Failed Metal on Metal Hip Implants Involving US Hip Implant Recipients and …
Press release: MHRA updates advice for metal-on-metal hip replacements : MHRA
Press release: MHRA updates advice for metal-on-metal hip replacements : MHRA. Press release: MHRA updates advice for metal-on-metal hip replacements …
Mark’s Story – another Smith & Nephew BHR disaster – 18 Months
Yesterday I was told the total hip resurfacing Smith and Nephew I received 9/2010 must be removed. They are doing …
The Power of the Birmingham Hip Resurfacing – NOT
Howard Sadwin – robbed of life Many of you will have read Howard Sadwin’s story and comments over the last …
FDA warns J&J’s DePuy unit over joint replacements – AlertNet
FDA warns J&J’s DePuy unit over joint replacements – AlertNet. FDA warns J&J’s DePuy unit over joint replacements 18 Jan …
More Hocus Pocus around the Smith & Nephew BHR Metallosis Problems
Correspondence from an “in pain and damaged BHR recipient” To: [deleted doctors name] Biosciences & Implants Unit Medical Devices Division …
Mesh Medical Device Newsdesk
Mesh Medical Device Newsdesk » latest news, information and perspective from the regulatory, industry and patient point of view, something …
Reforming the 510(k) Process: Where We Are, How We Got Here, and What’s to Come | MDDI Medical Device and Diagnostic Industry News Products and Suppliers
Reforming the 510(k) Process: Where We Are, How We Got Here, and What’s to Come | MDDI Medical Device and …
Howards View on the FDA and Medical Device Failures
Recent Information from the FDA on Failures This information came from FDA news. The FDA says approximately 44% of device …
More Smith & Nephew BHR Problems
More Smith & Nephew BHR – MoM Problems Emerging each day Comment received overnight: I too have a Smith and …
Howard View – on a few things
Great to see the activity pick up re: metal on metal hip devices, and yes they can be hazardous to …
FDA – Priorities, staffing impede inspections of drug, device makers – JSOnline
Priorities, staffing impede inspections of drug, device makers – JSOnline. Priorities, staffing impede inspections of drug, device makers Some not …
Zimmer knee replacement manufacturer sued for metal on metal design | Louisiana Record
Zimmer knee replacement manufacturer sued for metal on metal design | Louisiana Record. Zimmer knee replacement manufacturer sued for metal …
Howard’s View – Get Your Health Right is Number One Priority
More and more people are sharing their stories of suffering because of this hip debacle. This is great, let’s others …
The regulatory standards for the approval of medical devices in Australia – Senate Inquiry
The regulatory standards for the approval of medical devices in Australia – Senate Inquiry On 16 June 2011 the Senate …
FDA seeks to include more women in medical device trials
FDA seeks to include more women in medical device trials. FDA seeks to include more women in medical device trials …
Howard Sdwin: What isn’t being published is the truth regarding the medical device world
What isn’t being published is the truth regarding the medical device world. by Howard Sadwin Howard’s Opinion: If we obtained …
San Francisco Personal Injury Attorney Analyzes Depuy Lawsuits And Preemption
San Francisco Personal Injury Attorney Analyzes DePuy Lawsuits And Preemption. DePuy Hip Implant Claims & Federal Preemption November 23, 2011 …
Howard Gets A New Hip – But Still Wants Justice
For those of you who have been following this blog for some time, you will recall the story of Howard …
MAKO aims to get hip-replacement patients back on feet faster
MAKO aims to get hip-replacement patients back on feet faster October 10, 2011 — 7:57am ET | By Liz Jones …
Howard Sadwin’s Story – a lesson in perserverance…
Howard’s Story (as written by Howard): My intentions are to tell my story, and for others to listen to my …
The rate at which FDA issues 483s and warning letters is going up, up, up.
The rate at which FDA issues 483s and warning letters is going up, up, up. Source: FDA email circular advertising …
Complaints Surge About Crumbling Artificial Hips
Complaints Surge About Crumbling Artificial Hips on August 23, 2011 Source: fairwarning.org As researchers scramble to assess the health dangers of …
FDA Proposes Guidelines That Clarify Benefit-Risk Determinations For Medical Devices
FDA Proposes Guidelines That Clarify Benefit-Risk Determinations For Medical Devices August 19, 2011 Source: Medical Design Online For the first …
IOM chair discusses 510(k) report: origins, findings, response
IOM chair discusses 510(k) report: origins, findings, response Written by Brian Dunham August 15, 2011 Source: Cardiovascular Business David …
FDA Loosens Premarket Notification Requirements for 30 Medical Device Types
FDA Loosens Premarket Notification Requirements for 30 Medical Device Types Written by: mdcieditor Wednesday, August 10th, 2011 | FDA Medical …
Sadwin gets to the heart of the Issues with FDA 510(k)
Sadwin gets to the heart of the Issues with FDA 510(k) I spend a good part of my day keeping …
FDA Enforcement Reports documented 233 medical device recalls involving nearly 16 million units
Recall Index – Second Quarter 2011 – Medical Devices Source:expertrecall.com During the second quarter of 2011, FDA Enforcement Reports documented …
Medical Devices — Balancing Regulation and Innovation
Medical Devices — Balancing Regulation and Innovation NEJM | August 10, 2011 | Topics: Drugs, Devices, and the FDA Gregory D. …
IOM Gives FDA The wrong prescription on medical devices & 510(k)
Editorial: The wrong prescription on medical devices Article by: EDITORIAL , Star Tribune Updated: August 6, 2011 – 6:19 …
How Safe Are Medical Devices?
How Safe Are Medical Devices? Published: August 4, 2011 New York Times A prestigious medical group is concerned that most …
Did IOM Put the Final Nail in the Coffin of Metal-on-Metal Hip Implants?
Did IOM Put the Final Nail in the Coffin of Metal-on-Metal Hip Implants? Published: August 3, 2011—Shana Leonard Source: MPMN …
FDA Seeks Public Views on Proposed 510(k) Plans
FDA Seeks Public Views on Proposed 510(k) Plans August 01, 2011 By a GenomeWeb staff reporter NEW YORK (GenomeWeb News) …
Australian TGA – Reforms in the medical devices regulatory framework: Overview of submissions
Reforms in the medical devices regulatory framework: Overview of submissions 11 February 2011 Background On 2 November 2010, the TGA released a …
Australian TGA – Reforms in the medical devices regulatory framework
Australian TGA – Reforms in the medical devices regulatory framework Consultation Source: TGA – Click here 2 November 2010 Relevant …
Australian TGA Response to Recall of DePuy ASR Hip Replacement
Recall of DePuy Orthopaedics ASR hip replacement device 16 May 2011 Source Therapeutic Goods Administration Recall of DePuy Orthopaedics ASR …
British Woman files product liability lawsuit against Wright Medical Technology
Wright Hip Replacement Lawsuit Filed by Woman from Great Britain Source: AboutlawSuites.com Published: July 29th, 2011 An U.K. woman has …
US Congress Women Rosa L. DeLauro Takes FDA To Task Over Comments re IOM Report
For Immediate Release Friday, July 29, 2011 Contact: Kaelan Richards 202-225-3661 DELAURO TO FDA: 510(k) MEDICAL DEVICE APPROVAL PROCESS UNSAFE, …
Report: FDA’s Medical Device Approval Process Is Flawed
Report: FDA’s Medical Device Approval Process Is Flawed Source: Click here MINNEAPOLIS (WCCO) – More than 100 medical devices have been …
510(k) approval process is too big to fail no matter how flawed it may be
7.29.11 | Arundhati Parmar Source: MedCityNews 510(k) approval process is too big to fail no matter how flawed it may …
U.S. advisers call for new medical device regime
U.S. advisers call for new medical device regime Andrew Seaman Reuters Full Edition July 30, 2011 WASHINGTON (Reuters) – An …
Barry Meier – Approval process for devices blasted
Approval process for devices blasted Barry Meier The Boston Globe July 30, 2011 The government’s system for regulating many medical …
Expert group calls for new way to clear medical devices
Expert group calls for new way to clear medical devices Christine Mai-Duc | Tribune Washington Bureau Source: ongo The Tennessean …
Sadwin Comments on Washington Post Article – Letter to Authors
Refer to: Advisory panel calls for revamping FDA approval process for medical devices Good morning: I just read your article …
Advisory panel calls for revamping FDA approval process for medical devices
Advisory panel calls for revamping FDA approval process for medical devices David Brown and N.C. Aizenman The Washington Post Ongo.com …
FDA Backs Quicker Reviews for Hip Implants in Reply to Panel’s Report
FDA Backs Quicker Reviews for Hip Implants in Reply to Panel’s Report By Anna Edney – Jul 30, 2011 2:27 …
Institute of Medicine – Public Health Effectiveness of the FDA 510(k) Clearance Process
Institute of Medicine – Public Health Effectiveness of the FDA 510(k) Clearance Process The report has been released Friday 29 …
Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs
Regulatory Reform Series #5 – FDA Medical Device Regulation: Impact on American Patients, Innovation and Jobs Source: FDA Website Statement …
Report could sway FDA device review process
Report could sway FDA device review process Source: Reuters By Andrew Seaman WASHINGTON | Tue Jul 26, 2011 1:40pm EDT (Reuters) – …
FDA 510K Process – Another Issue – Risky pelvic mesh highlights worries about FDA process
Risky pelvic mesh highlights worries about FDA process Untested medical devices found to erode patients’ insides Source: MSNBC.com By Rita Rubin; …
Barry Meier – Study Faults Approval Process for Medical Devices
Study Faults Approval Process for Medical Devices BY BARRY MEIER PUBLISHED: JULY 29, 2011 NEW YORK TIMES The government’s system for regulating …
510(k) reforms: FDA downplays the impact of the IOM study on the eve of its release
510(k) reforms: FDA downplays the impact of the IOM study on the eve of its release July 28, 2011 by MassDevice staff …
Sadwin has a few other Pithy Points for the Orthopaedic “Big Guys”…
[Earl’s View] Comment: “Bruce Greenfield may be the last New Zealander implanted with a faulty hip joint “ Market share …
Barry Meier – Study of Medical Device Rules Is Attacked, Unseen
Study of Medical Device Rules Is Attacked, Unseen By BARRY MEIER New York Times – Click here Published: July 27, 2011 Allies of …
Can’t shoot the Messenger [Sales Rep] …
Remand Denials in Hip Implant MDL Source: click here We’ve just found out about multiple remand denials from the Depuy hip …
Why Are Pharmaceutical Companies Paying The FDA?
Why Are Pharmaceutical Companies Paying The FDA? Posted by Amber Racine J uly 27, 2011 10:31 AM Source: Click here The FDA …
Report: IOM review of the FDA 510(k) process due Friday
Report: IOM review of the FDA 510(k) process due Friday July 27, 2011 by Brendon Nafziger, DOTmed News Associate Editor; Source …
FDA medical device review times to be subject of House hearing
FDA medical device review times to be subject of House hearing The House Energy & Commerce Committee’s oversight subcommittee is …
Scientists push biocompatible materials for use in orthopaedic implants
Materials Research Gets Under the Skin Scientists push biocompatible materials to interact with their surroundings in intelligent ways By: Stephanie …
Is Medical Device Design Going to the Dogs?
Is Medical Device Design Going to the Dogs? Published: May 23, 2011 The Massachusetts-based Worcester Business Journal featured an interesting …
Roundtable: Evolution, Not Revolution, Drives Biomaterials Development
Published: Tue, Nov 30, 2010 – 11:25 am Roundtable: Evolution, Not Revolution, Drives Biomaterials Development MPMN 25th Anniversary Coverage Marcus …
DePuy ASR Hip Implant was Untested
DePuy ASR Hip Implant was Untested Date Published: Monday, April 4th, 2011 Could the controversial recalled DePuy hip replacement devices …
Senate Hearing on FDA Medical Device Approvals
DePuy Hip Implant Recall to be Featured at Senate Hearing on FDA Medical Device Approvals Date Published: Wednesday, April 13th, …
FDA 510K Process for Medical Devices Let Unsafe Devices Through
FDA Again Criticized for Medical Device Oversight Date Published: Wednesday, April 13th, 2011 Thousands of medical devices are approved annually …
Swimmer Files Suit over DePuy ASR
Former Swimmer Files Suit over DePuy ASR Hip Resurfacing System Date Published: Tuesday, June 28th, 2011 A former competitive swimmer …
Zimmer NexGen MIS Tibial Component Recall
Zimmer NexGen Component Recall The Zimmer NexGen MIS tibial component recall affected 68,384 knee components, which were distributed in 13 …
Corin Cormet FDA Approval – At Least the FDA Panel included Metal Ion Serum Levels
Orthopaedic and Rehabilitation Devices Panel – February 22, 2007 The Orthopaedic and Rehabilitation Devices Panel (the Panel) met on Thursday, …
Corin 510K Approval Details
Corin FDA Approvals Source: click here Corin 510K Biolox FDA Approval K103120.pdf Corin Minhip K083312.pdf Corin BIOLOX delta Modular Femoral …
Sadwin Gives them a Sterling Suggestion or Two
Just in from Howard’s Desk (wheel chair) … I just sent a feedback message to med page. How ridiculous it …
