FDA
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Hospitals
Bill to protect FDA user fees introduced in the U.S. House of Representatives
February 25, 2015 by Val Kennedy Industry trade association AdvaMed applauds a bill introduced into the U.S. House of Representatives…
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Hospitals
Smart Ways to Manage Health Need Smart Regulation
By: Bakul Patel, M.S., M.B.A. and Jeffrey Shuren, M.D., J.D. Engaged patients! Quantified self! Lifelogging! These buzzwords describe an exciting…
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Hospitals
U.S. FDA Commissioner Margaret Hamburg to step down
BY TONI CLARKE (Reuters) – Dr. Margaret Hamburg, who as commissioner of the U.S. Food and Drug Administration (FDA) for…
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K2M receives FDA 510(k) clearance for the next generation of its innovative complex spine MESA(R) technology
K2M Group Holdings, Inc., a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine…
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Biologics
Use of Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients under Age 18 – FDA Safety Communication
Date Issued: January 21, 2015 Audiences: Healthcare providers Patients under age 18 with bone grown defects Parents/Guardians of patients under…
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Hospitals
A CDRH Priority: Clinical Trials in the U.S.
By: Owen Faris, Ph.D., and Jeffrey Shuren, M.D., J.D. At the Center for Devices and Radiological Health (CDRH), clinical trials…
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Extremities
An FDA perspective on the use of 3D printing in medical applications
By Norbert Sparrow Published: January 5th, 2015 A dedicated follower of 3D printing in the medical space, Steven K. Pollack,…
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Hospitals
MiMedx pleased with FDA Draft Guidance on Minimal Manipulation of HCT/Ps
MiMedx Group, Inc. (NASDAQ: MDXG), the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and…
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Hospitals
CDRH Customer Satisfaction Rating (Do you feel the same way?)
This page provides real time results for CDRH’s customer satisfaction survey. The March 14, 2014 date on this page reflects…
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Hospitals
FDA Cancels Study of How it Can Use Drones to Conduct Inspections
Posted 19 December 2014 By Alexander Gaffney, RAC The US Food and Drug Administration (FDA) is no longer considering the…
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Financial
FDA PANEL EXPERT LINKS TO INDUSTRY A MYSTERY
Walter Eisner • Thu, December 18th, 2014 A December 8, 2014 Wall Street Journal article says the FDA is not…
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Financial
FDA Often Fails to Disclose Advisers’ Corporate Ties
By ED SILVERMAN Many of the physicians and other experts who sit on FDA advisory panels to review medical devices have…
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Spine
FDA approves J&J spinal device for rare pediatric syndrome
December 8, 2014 by Val Kennedy Johnson & Johnson’s DePuy Synthes Spine unit wins an FDA nod for a titanium…
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Hospitals
As recalls increase, hospitals should embrace medical device tracking
by Dan Verel As hospitals across the country look for ways to become more efficient with the use of technology,…
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Spine
FDA Approves Injectable Device for Back, Leg Pain
By Susan Jeffrey Medscape Medical News Dec. 4, 2014 — The FDA has approved an injectable microchip nerve-stimulation device…
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