Jeffrey Shuren

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Type: Person
Name: Jeffrey Shuren
First reported Jun 18 2013 - Updated Jun 18 2013 - 1 reports

Firmer Breast Implant Gets FDA Nod

The FDA gave the go ahead to a new firmer silicon gel implant for breast augmentation or reconstruction but will require long-term safety reassurance.The MemoryShape Breast Implant has more cross-linking of silicon chains to boost the firmness of the ... [Published Surgical Products - Jun 18 2013]
First reported Jun 14 2013 - Updated Jun 14 2013 - 1 reports
Allergan Inc
Allergan Inc

FDA Approves New Silicone-Gel Breast Implant

New Silicone-Gel Breast Implant Approved by FDAMedscape Medical NewsMore from WebMDFeb. 21, 2013 -- The FDA has approved a new silicone-gel breast implant from Allergan called Natrelle 410. It will be used to increase breast size in women 22 and older, ... [Published LEX18 - Jun 14 2013]
First reported Jun 05 2013 - Updated Jun 05 2013 - 1 reports

Innovative Medical Design and Virtual Prototyping Tool May Reduce Clinical Trial Burden

Clinical trials - oh, how to describe them.Patient advocates would say they are absolutely mandatory to ensure safety of devices. Device industry would likely argue that they are necessary mainly for many complex devices.But no matter what vested interest ... [Published Medical Device & Diagnostic Industry - Jun 05 2013]
First reported Jun 04 2013 - Updated Jun 04 2013 - 1 reports

ATA Federal Telemedicine Policy Summit

Jun. 27 - 28, 2013 Hyatt Regency Capitol Hill0 printJoin the conversation and hear the latest, inside information about the swift changes underway in healthcare delivery, public policy and the opportunities these provide for those involved in tel ... [Published MHIMSS - Jun 04 2013]
First reported May 28 2013 - Updated May 28 2013 - 1 reports

EU's CE Mark System Draws Criticism for Endangering Patients

The United States and Europe have some of the best healthcare systems in the world. While both the the FDA and CE Mark regulatory systems give patients access to top-of-the-line medical technologies, both systems have been alleged to suffer from significant ... [Published QMED - May 28 2013]

More Content

All (21) | News (16) | Reports (0) | Blogs (5) | Audio/Video (0) | Fact Sheets (0) | Press Releases (0)
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Firmer Breast Implant Gets FDA Nod [Published Surgical Products - Jun 18 2013]
FDA approves a new silicone gel-filled breast i... [Published EMax Health - Jun 16 2013]
Firmer Silicon Gel Implant Gets FDA Go Ahead [Published MediLexicon - Jun 15 2013]
MemoryShape Breast Implants receive FDA approval [Published News-Medical.Net - Jun 15 2013]
FDA approves Mentor's new silicone gel breast i... [Published NBCNews.com - Jun 15 2013]
6/14/13 - FDA approves a new silicone gel-fille... [Published Pharmacy Choice - Jun 14 2013]
FDA approves a new silicone gel-filled breast i... [Published Noodls - Jun 14 2013]
FDA Approves New Silicone-Gel Breast Implant [Published LEX18 - Jun 14 2013]
The FDA Nine: 10 People Who Changed the Medtech... [Published Medical Device & Diagnostic Industry - Jun 13 2013]
Innovative Medical Design and Virtual Prototypi... [Published Medical Device & Diagnostic Industry - Jun 05 2013]
ATA Federal Telemedicine Policy Summit [Published MHIMSS - Jun 04 2013]
Marin General Hospital's Nurses are Afraid a De... [Published Health Care Renewal - May 30 2013]
EU's CE Mark System Draws Criticism for Endange... [Published QMED - May 28 2013]
“DC Butt Doctor” Dr. Widder Says Gummy Bear Imp... [Published PRWeb - May 01 2013]
FDA Approves Silicone Gel Breast Implant Withou... [Published Our Bodies Our Blog - Mar 11 2013]
Peering Underneath the Iceberg's Water Level: A... [Published Health Care Renewal - Feb 28 2013]
Allergan's silicone gel-filled breast implant, ... [Published PharmaBiz - Feb 22 2013]
FDA Approves First Retinal Implant for Adults W... [Published Science Daily - Feb 19 2013]
Kaiser Health News/Philadelphia Inquirer on Med... [Published Health Care Renewal - Feb 18 2013]
ECRI Institute PSO Uncovers Health Information ... [Published Health Care Renewal - Feb 09 2013]
US FDA creates PPP to develop regulatory scienc... [Published PharmaBiz - Dec 05 2012]
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In Focus
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Mary Wakefield, Diana Zuckerman, Barbara Ryan, [more]
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Allergan Inc, Poly Implant Prothèse SA, Hyatt Regency SA, [more]
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FDA Food & Drug Administration, Center for Devices and Radiological Health, Federal Communications Commission, [more]
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breast implant, Implants, Medical Devices, [more]
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CE-mark, Botox
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Santa Barbara (United States), Plymouth Meeting (United States), Philadelphia (Pennsylvania, United States), [more]
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United States, Slovakia, Australia
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Diseases, Research & Development, Health Care, [more]
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IT, Health, Pharma & Biotech
Health Care Renewal, MHIMSS, Medical Device & Diagnostic Industry, [more]
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Blogs

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Marin General Hospital's Nurses are Afraid a De... [Published Health Care Renewal - May 30 2013]
The following appeared in the Marin County Independent Journal about an EHR system so bad the nurses at Marin General Hospital were publicly complaining, putting their careers at risk (see my May 17, 2013 post " Marin General Hospital nurses warn that ...
FDA Approves Silicone Gel Breast Implant Withou... [Published Our Bodies Our Blog - Mar 11 2013]
In late February, the FDA approved the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant  for breast augmentation in women age 22 and older and breast reconstruction in women of any age. It surprises us that the FDA ...
Peering Underneath the Iceberg's Water Level: A... [Published Health Care Renewal - Feb 28 2013]
FDA's Center for Devices and Radiological Health director Jeffrey Shuren MD JD voiced the opinion a few years ago that what FDA knows about health IT risks is the "tip of the iceberg" due to systematic impediments to knowledge gathering and diffusion.   ...
Kaiser Health News/Philadelphia Inquirer on Med... [Published Health Care Renewal - Feb 18 2013]
At my Dec. 2012 post " How an interview for Kaiser Health News rekindled memories of health IT dysfunction in the 90's that persist in the 10's " I mentioned an interview by a reporter from the Kaiser Health Foundation interviewed me regarding health ...
ECRI Institute PSO Uncovers Health Information ... [Published Health Care Renewal - Feb 09 2013]
As I wrote here , I was a reviewer of the PA-based, ECRI Institute-conducted study report " The Role of the Electronic Health Record in Patient Safety Events " of the PA database for HIT-related errors.   The ECRI Institute is an independent organization ...
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