Investigational Device Exemption

Type: Keyphrase
Name: Investigational Device Exemption
First reported Apr 17 2014 - Updated Apr 17 2014 - 1 reports

Research and Markets Adds Report: 'United States Regulatory and Reimbursement Scenario for Medical Devices 2013-2018'

Research and Markets has announced the addition of the "United States Regulatory and Reimbursement Scenario for Medical Devices 2013-2018" report to its offerings.In a release, Research and Markets noted that report highlights include:Changing Regulatory ... [Published Individual.com - Apr 17 2014]
First reported Apr 17 2014 - Updated Apr 17 2014 - 1 reports

Aethlon Medical : AEMD Note: U.S. Clinical Progression

By a News Reporter-Staff News Editor at Biotech Week -- Aethlon Medical, Inc. (OTCQB: AEMD), released the following note authored by its Chairman and CEO, Jim Joyce (see also Aethlon Medical, Inc. ).http://photos.prnewswire.com/prnvar/20090325/LA8876 ... [Published 4 Traders - Apr 17 2014]
First reported Apr 16 2014 - Updated Apr 16 2014 - 1 reports

United States : CERAPEDICS closes $9 million venture debt financing from GE Capital

A $9 million venture debt financing has been closed by Cerapedics from GE Capital , Healthcare Financial Services .The $9 million loan would back up general business operations for Cerapedics, comprising the advancement of the company's United States ... [Published HispanicBusiness.com - Apr 16 2014]
First reported Apr 16 2014 - Updated Apr 16 2014 - 1 reports

Avita Medical Limited Reports Investigational Device Exemption for ReCell

(Close-Up Media via COMTEX News Network) -- Avita Medical Limited announced that it has been granted Investigational Device Exemption for the compassionate use of ReCell 'Spray-on Skin' by the United States Food and Drug Administration to evaluate clinical ... [Published PredictWallStreet - Apr 16 2014]
First reported Apr 16 2014 - Updated Apr 16 2014 - 1 reports

Rox Completes Enrollment in Blood Pressure Device Trial

Rox Medical has completed enrollment in a Phase III trial of its Rox Coupler blood pressure reduction device. Final results from the study are expected by fall.The multicenter, prospective, randomized, controlled and double-endpoint blinded trial will ... [Published FDA News - Apr 16 2014]
First reported Apr 15 2014 - Updated Apr 15 2014 - 1 reports

Another FDA win for Reverse Medical with IDE nod for Barrel vascular device

Reverse Medical wins FDA approval to launch U.S. clinical trials of its Barrel vascular reconstruction device for use in treating aneurysms.California-based Reverse Medical landed key FDA approval to launch U.S. clinical trials of its Barrel vascular ... [Published MassDevice - Apr 15 2014]
First reported Apr 14 2014 - Updated Apr 14 2014 - 1 reports

Cerapedics Announces Closing of Venture Debt Loan from GE Capital

/PRNewswire/ -- Cerapedics, an orthobiologics company focused on developing and commercializing its proprietary synthetic small peptide (P-15) technology platform, today announced closing of a $9 million venture debt financing from GE Capital, Healthcare ... [Published TickerTech.com - Apr 14 2014]
First reported Apr 10 2014 - Updated Apr 11 2014 - 4 reports

United States Food and Drug Administration Grants an Investigational Device Exemption for Compassionate Use of ReCell

United States Food and Drug Administration Grants an Investigational Device Exemption for Compassionate Use of ReCell ... [Published Noodls - Apr 11 2014]
First reported Apr 11 2014 - Updated Apr 11 2014 - 2 reports

Research and Markets: United States Regulatory and Reimbursement Scenario for Medical Devices 2013-2018

DUBLIN--(BUSINESS WIRE)--Apr. 11, 2014-- Research and Markets (http://www.researchandmarkets.com/research/jhtxz3/changing) has announced the addition of the report to their offering.Changing Regulatory and Reimbursement Scenario for Medical Devices in ... [Published BusinessWeek - Apr 11 2014]
First reported Apr 10 2014 - Updated Apr 10 2014 - 2 reports

United States Food and Drug Administration Grants an investigational device exemption for Avita Medical Ltd compassionate use of ReCell

United States Food and Drug Administration Grants an investigational device exemption for Avita Medical Ltd compassionate use of ReCell 5:00am BSTAvita Medical Ltd:Says it has been granted Investigational Device Exemption for the compassionate use of ... [Published Reuters UK - Apr 10 2014]
First reported Apr 02 2014 - Updated Apr 03 2014 - 6 reports

CryoLife Receives FDA Approval to Begin Clinical Trials for PerClot in the United States

/PRNewswire/ -- CryoLife, Inc. (NYSE: CRY), a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today that it has received approval of its Investigational Device Exemption (IDE) for PerClot from the ... [Published Vascular Disease Management - Apr 02 2014]
First reported Mar 20 2014 - Updated Mar 21 2014 - 2 reports

Abiomed completes patient enrollment in RECOVER RIGHT Impella study

Abiomed has announced that the patient enrollment in the RECOVER RIGHT Impella study has been completed with the 30th patient enrolled in the study.The Investigational Device Exemption (IDE) study of Impella (right peripheral) has been designed to enroll ... [Published Medical Devices Business Review - Mar 21 2014]

Quotes

"With the recent presentation of our preliminary outcomes data for i-FACTOR™ Peptide Enhanced Bone Graft, we are pleased to announce closing of this loan agreement with GE Capital, which will position us to continue our progress toward US regulatory approval and commercialization in the months ahead" said Jeffrey G Marx, Ph D , president and chief operating officer at Cerapedics
"It is a true intravascular agent," he said. "So there is a little difference from CT and MR, where there's extravasation of contrast in the later phases."
...have received this approval, which will allow us to begin our US clinical trial for PerClot," stated Steven G Anderson, CryoLife president and CEO. "Based on the anticipated enrollment and follow up timeline, we could potentially receive pre-market approval for PerClot by the end of 2"
...support from our investor consortium as we continue to build Sequent into a leading neurovascular franchise," Wilder said in prepared remarks . "We will use the funds to continue our introduction of the Web aneurysm embolization system, including execution of our planned US IDE clinical study, and to broaden our product portfolio."

More Content

All (128) | News (121) | Reports (0) | Blogs (3) | Audio/Video (0) | Fact Sheets (0) | Press Releases (4)
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Research and Markets Adds Report: 'United State... [Published Individual.com - Apr 17 2014]
Aethlon Medical : AEMD Note: U.S. Clinical Prog... [Published 4 Traders - Apr 17 2014]
United States : CERAPEDICS closes $9 million ve... [Published HispanicBusiness.com - Apr 16 2014]
Cerapedics closes on $9 million venture debt lo... [Published Orthopedics Today - Apr 16 2014]
Avita Medical Limited Reports Investigational D... [Published PredictWallStreet - Apr 16 2014]
Rox Completes Enrollment in Blood Pressure Devi... [Published FDA News - Apr 16 2014]
Another FDA win for Reverse Medical with IDE no... [Published MassDevice - Apr 15 2014]
Cerapedics Announces Closing of Venture Debt Lo... [Published TickerTech.com - Apr 14 2014]
Georgetown Researchers Study Nonsurgical, Minim... [Published The ASCO Post - Apr 11 2014]
United States Food and Drug Administration Gran... [Published Noodls - Apr 11 2014]
FzioMed Announces Date for Medical Device Dispu... [Published CNBC - Apr 11 2014]
Research and Markets: United States Regulatory ... [Published BusinessWeek - Apr 11 2014]
United States Regulatory and Reimbursement Scen... [Published Individual.com - Apr 11 2014]
OncoSil Medical Progresses CE Mark Submission F... [Published Seeking Alpha - Apr 11 2014]
OncoSil Medical progresses CE Mark submission f... [Published Proactive Investors Australia - Apr 11 2014]
United States Food and Drug Administration Gran... [Published PR inside - Apr 10 2014]
Avita Medical : US FDA Grants ReCell Investigat... [Published Investegate - Apr 10 2014]
United States Food and Drug Administration Gran... [Published Marketwire - Breaking News Releases - Apr 10 2014]
United States Food and Drug Administration Gran... [Published Reuters UK - Apr 10 2014]
United States Food and Drug Administration Gran... [Published Reuters - Apr 10 2014]
First Patient In U.S. To Receive MRI Scan In St... [Published KHTS AM-1220 - Apr 09 2014]
Sequent Medical secures $20 million in Series D... [Published Individual.com - Apr 09 2014]
Off-label use unlocks contrast ultrasound for r... [Published Aunt Minnie - Apr 09 2014]
CryoLife's IDE to initiate hemostasis trial rec... [Published Individual.com - Apr 09 2014]
Sequent Medical raises $20M Series D for brain ... [Published MassDevice - Apr 08 2014]
Abiomed wins CE Mark for Impella RP heart pump [Published MassDevice - Apr 08 2014]
MELA SCIENCES : Determination of Regulatory Rev... [Published 4 Traders - Apr 07 2014]
FDA approves first upgradeable neurostimulation... [Published Medical Device Daily - Apr 05 2014]
World's First and Only Upgradeable Spinal Cord ... [Published Nasdaq - Apr 04 2014]
CryoLife gets US FDA nod to start clinical tria... [Published PharmaBiz - Apr 04 2014]
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United States Food and Drug Administration Gran... [Published Marketwire - Breaking News Releases - Apr 10 2014]
NORTHRIDGE, CA and CAMBRIDGE, UNITED KINGDOM--(Marketwired - Apr 10, 2014) - Avita Medical Limited (ASX: AVH), (OTCQX: AVMXY) ...
CryoLife Receives FDA Approval to Begin Clinica... [Published PR Newswire: Health - Apr 02 2014]
ATLANTA, April 2, 2014 /PRNewswire/ -- CryoLife, Inc. (NYSE: CRY), a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today that it has received approval of its Investigational Device Exemption (IDE) ...
OncoSil Medical appoints Natalie Ruffles as its... [Published Proactiveinvestors United Kingdom website - Feb 13 2014]
OncoSil Medical ( ASX: OSL ) has appointed Natalie Ruggles as its vice president of clinical research with the responsibility for managing all clinical studies being conductedThis includes managing all operational and logistical tasks relating to clinical ...
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Cesca Therapeutics Submits pre-IDE Information ... [Published GlobeNewswire: Advertising News - Mar 26 2014]
New Record of 161 SynCardia Total Artificial He... [Published PR Newswire - Jan 07 2014]
Brainsway Receives FDA Approval of IDE for Obse... [Published GlobeNewswire: Acquisitions News - Dec 19 2013]
Respicardia maakt eerste commerciële implantaat... [Published PR Newswire - Aug 28 2013]
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