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Draft Guidance for Industry and Food and Drug Administration Staff - Providing Information about Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act

February 15, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Section 302 of Title III of the Food and Drug Administration Amendments Act of 2007 (FDAAA), created Section 515A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e). Section 515A requires submitters to FDA of premarket approval..

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Meeting Announcement: March 20, 2013 Circulatory System Devices Panel of the Medical Devices Advisory Committee

February 15, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

On March 20, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for the MitraClip Delivery System sponsored by Abbott Vascular. The system consists of three major components: the delivery catheter, the steerable sleeve, and the MitraClip device.

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Medical Imaging Drugs Advisory Committee Recommends Approval of Guerbet NDA for Dotarem@ (gadoterate meglumine)

February 14, 2013 5:07 pm | by The Associated Press | News | Comments

Guerbet, the contrast agent specialist for medical imaging, today announced that the Medical Imaging Drugs Advisory Committee to US Food and Drug Administration (FDA) has voted unanimously by votes of 17 to 0 to recommend that FDA approve the New Drug Application (NDA) for Dotarem@ ...

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Bard to Present at Citi 2013 Global Healthcare Conference

February 14, 2013 4:21 pm | by The Associated Press | News | Comments

MURRAY HILL, N.J.--(BUSINESS WIRE)--Feb 14, 2013--C. R. Bard, Inc. (NYSE: BCR) today announced that it will present at the Citi 2013 Global Healthcare Conference in New York City on February 27, 2013. Timothy M. Ring, chairman and chief executive officer, will discuss the Company in a presentation...

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Medical Aesthetics: Cynosure, Syneron Gain on Swings to Black

February 14, 2013 4:03 pm | by Mass Device | News | Comments

If their 4th-quarter and full-year results are anything to go by, the slumping medical aesthetics market is on the rebound, as Syneron Medical Ltd. and Cynosure report returns to profitability. Both of the companies, which make cosmetic medical devices, posted strong double-digit sales growth for the 3 and 12 months ended Dec. 31, 2012.

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US Patent Innovations, LLC Completes Plasma Technology Research Agreement with The George Washington University

February 14, 2013 3:48 pm | by The Associated Press | News | Comments

TAKOMA PARK, Md.--(BUSINESS WIRE)--Feb 14, 2013--US Patent Innovations, LLC (USPI), a private biomedical devices company, announced today that it signed a five-year research agreement with The George Washington University of Washington, D.C. (GWU) on February 6, 2013. Under the agreement, USPI...

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More Hip Recalls for Johnson & Johnson

February 14, 2013 3:36 pm | by Mass Device | News | Comments

A German newspaper reports that healthcare giant Johnson & Johnson is recalling another of its metal-on-metal hip implants. International reports today suggest that healthcare giant Johnson & Johnson (NYSE:JNJ) recalled its Adept hip replacement system, another in its line of troubled metal-on-metal hip implants.

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Sirona Gains Despite Flat profits

February 14, 2013 3:10 pm | by Mass Device | News | Comments

Dental device company Sirona Medical Systems reports 1st-quarter sales of 5.5% and flat profit growth. Sirona Dental Systems (NSDQ:SIRO) reported flat profits for its fiscal 1st quarter, but that didn't faze investors, who sent share prices up nearly 4% this week.

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Eye Implant Can Restore Some Vision in Rare Cases

February 14, 2013 2:59 pm | by The Associated Press | News | Comments

Patients who have lost their sight due to a rare disorder may be able to regain some vision using a new implantable device that takes the place of damaged cells inside the eye. The Food and Drug Administration on Thursday approved the Argus II Retinal Prosthesis System as the first treatment for...

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NIH Chief: Cuts Put Vital Medical Research at Risk

February 14, 2013 2:24 pm | by LAURAN NEERGAARD - AP Medical Writer - Associated Press | News | Comments

Better cancer drugs that zero in on a tumor with fewer side effects. A universal flu vaccine that could fight every strain of influenza without needing a yearly shot. Research into potentially life-saving products like these will be delayed and newer discoveries shelved if Congress can't avert...

NewBridge Pharmaceuticals to Commercialize the verifi(R) Prenatal Test

February 14, 2013 1:15 pm | by The Associated Press | News | Comments

NewBridge Pharmaceuticals, a specialty therapeutics company commercializing pharmaceuticals, biologics, diagnostics and medical devices across the AfMET region (Middle East, Africa, Turkey & Caspian regions), today announced that the company has established an exclusive agreement with...

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DR Systems Announces Issuance of U.S. Patent for Systems and Methods for Matching, Naming and Displaying Medical Images

February 14, 2013 1:11 pm | by The Associated Press | News | Comments

SAN DIEGO--(BUSINESS WIRE)--Feb 14, 2013--DR Systems, the leading independent provider of enterprise-wide medical imaging and information systems, announced that the United States Patent and Trademark Office (USPTO) has issued to the company a new patent, relating to a method of matching medical...

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Stratos and Siemens Healthcare Diagnostics Will Lead a Presentation at the Frost & Sullivan Medical Devices Executive Mind Xchange

February 14, 2013 12:48 pm | by The Associated Press | News | Comments

Stratos Product Development, LLC today announced its President, Sean MacLeod, will lead a presentation for executives on innovation at the Frost & Sullivan Medical Devices Executive Mind Xchange on March 12, 2013 in San Diego, California. MacLeod will co-present with...

Second Sight Medical Products Receives FDA Approval for Argus II System

February 14, 2013 11:45 am | by The Associated Press | News | Comments

SYLMAR, Calif.--(BUSINESS WIRE)--Feb 14, 2013--After more than 20 years of research and development, Second Sight Medical Products, Inc., the leading developer of retinal prostheses for the blind, is pleased to announce that its Argus® II Retinal Prosthesis System (“Argus II”) has received U.S....

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A "New Era" for Boston Scientific?

February 14, 2013 11:18 am | by Mass Device | News | Comments

Boston Scientific (NYSE:BSX) expects positive sales growth for the company by the 2nd half of 2013, CFO Jeffrey Capello told MassDevice.com in an interview. A return to positive sales growth would end nearly 2.5 years of sliding revenues, and the medical device maker still has some rough patches to navigate, he said.

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