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Latest Investigational Device Exemption Stories

2014-06-10 08:29:19

SAN JOSE, Calif., June 10, 2014 /PRNewswire/ -- Pulsar Vascular, the innovator and developer of the PulseRider®, a minimally invasive, aneurysm neck reconstruction device, announced today the United States Food and Drug Administration (FDA)'s approval of an Investigational Device Exemption (IDE) for the PulseRider. The IDE allows Pulsar Vascular to begin a multicenter clinical trial in support of a Humanitarian Device Exemption (HDE) to evaluate the PulseRider for US approval for...

2014-05-05 08:28:39

SINGAPORE, May 5, 2014 /PRNewswire/ -- Biosensors International Group, Ltd. ("Biosensors" or the "Company", Bloomberg: BIG SP; Reuters: BIOS.SI; SGX: B20), a developer, manufacturer and marketer of innovative medical devices, announced today that the U.S. Food and Drug Administration (FDA) recently granted conditional Investigational Device Exemption (IDE) approval for a U.S.-based clinical trial of the BioFreedom(TM) polymer-free drug-coated stent (DCS) system. The BioFreedom U.S....

2014-04-10 08:29:04

DUBLIN, April 10, 2014 /PRNewswire/ -- Research and Markets ( http://www.researchandmarkets.com/research/t45c8d/fda_approval) has announced the addition of the "FDA Approval Process for Medical Devices - Updated Programme Includes all the Current FDA Guidelines (Seminar, London)" [http://www.researchandmarkets.com/research/t45c8d/fda_approval ]conference to their offering. (Photo: http://photos.prnewswire.com/prnh/20130307/600769 ) The FDA Approval Process...

2014-03-11 16:26:18

Results provide significant support to advance i-FACTOR(TM) Peptide Enhanced Bone Graft for FDA regulatory review. WESTMINSTER, Colo., March 11, 2014 /PRNewswire/ -- Cerapedics, Inc., an orthobiologics company focused on developing and commercializing novel peptide enhanced bone graft products based on its proprietary synthetic small peptide (P-15) technology platform, today presented preliminary outcomes data from a FDA Investigational Device Exemption (IDE) clinical trial for...

FDA Regulatory Process Variable
2014-01-22 09:31:53

Rebekah Eliason for redOrbit.com – Your Universe Online According to a recent study, the approval of drugs by the Food and Drug Administration (FDA) is based on widely varying clinical trials between 2005 and 2012. The background from the article states that “FDA review of new drug applications is guided by the Federal Food, Drug, and Cosmetic Act, which requires 'adequate and well controlled investigations' to determine efficacy. Many patients and physicians assume that the safety...

2013-05-04 23:01:24

“Changing Regulatory and Reimbursement Scenario for Medical Devices in the US Market” is the new market research report added to ReportsnReports.com store. Dallas, Texas (PRWEB) May 04, 2013 Changing Regulatory and Reimbursement Scenario for Medical Devices in the US Market looks at the regulatory landscape and reimbursement scenario in the US for four medical device markets: cardiovascular devices, neurostimulation devices, diagnostic imaging devices and endoscopy devices. The...

2013-05-04 23:01:20

Researchmoz.us includes new market research report "Changing Regulatory and Reimbursement Scenario for Medical Devices in the US Market" to its huge collection of research reports. Albany, NY (PRWEB) May 04, 2013 Researchmoz presents this most up-to-date research on Changing Regulatory and Reimbursement Scenario for Medical Devices in the US Market. The report focuses primarily on quantitative market metrics in order to characterize the growth and evolution of the Reimbursement Scenario for...


Word of the Day
callithump
  • A somewhat riotous parade, accompanied with the blowing of tin horns, and other discordant noises; also, a burlesque serenade; a charivari.
'Callithump' is a back-formation of 'callithumpian,' a 'fanciful formation' according to the Oxford English Dictionary. However, the English Dialect Dictionary, says 'Gallithumpians' is a Dorset and Devon word from the 1790s that refers to 'a society of radical social reformers' or 'noisy disturbers of elections and meetings.'
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