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- Clinical Trial
- a statistical study of human subjects to determine the effectiveness of a medical treatment
- Clinical Trial definition on BNET »
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- FDA Approves 'IDE' Clinical Trial of Paradigm Spine's Coflex(TM) Functionally Dynamic Interspinous Implant.
- NEW YORK, May 9 /PRNewswire/ -- NEW YORK, May 9 /PRNewswire/ --
- Research articles 2006-05-09
- FDA Grants IDE Approval to TransMedics for the Pilot Phase of the PROCEED Clinical Trial for Its Organ Care System™ - the First System to Support Beating Heart Transplant
- ANDOVER, Mass. -- TransMedics, Inc., an emerging medical technology company developing advanced solutions for better, more organ transplant technologies, announced today it has received IDE approval to initiate the pilot phase of the PROCEED multi-center clinical trial in the U.S. for its Organ Care System[TM]. The PROCEED trial will evaluate...
- Research articles 2007-04-19
- Interpore International to initiate pilot clinical trials for expanded use of Pro Osteon; FDA Approves IDE for Iliac Crest Studies
- IRVINE, Calif.--BUSINESS WIRE--May 21, 1996--Having received approval from the Food and Drug Administration, Interpore International (NASDAQ/NM:BONZ), the leading manufacturer of synthetic bone graft materials, announced it will initiate limited human clinical trials for use of its Pro Osteonr Implant 500 as an autograft donor site backfill material.
- Research articles 1996-05-21
- Thoratec Files IDE for Vascular Access Graft; Data Allows FDA to Determine Whether Clinical Trials Can Commence
- PLEASANTON, Calif.--BW HealthWire--Dec. 4, 1997--Thoratec Laboratories Corporation (NASDAQ:THOR), a medical device company, today announced that it has filed an investigational device exemption IDE for its vascular access graft VAG.
- Research articles 1997-12-04
- American BioMed files IDE with FDA to conduct OmniCath AV fistula graft clinical trials
- THE WOODLANDS, Texas--BW HealthWire--Feb. 11, 1997--American BioMed Inc. (NASDAQ/EBB:ABMI) Tuesday announced that it has filed an IDE with the Food and Drug Administration for its OmniCathr atherectomy catheter for hemodialysis AV fistula restenosis clinical trials.
- Research articles 1997-02-11
Additional Resources
- FDA Approves Clinical Trial For Medtronic's DIAM Spinal Stabilization System
- MEMPHIS, Tenn. -- Medtronic, Inc. (NYSE:MDT) announced today that the U.S. Food and Drug Administration has granted an investigational device exemption IDE to the DIAM[TM] Spinal Stabilization System for use in a second U.S. clinical study. This prospective, randomized, controlled pivotal IDE clinical trial will attempt to prove the DIAM...
- Research articles 2006-09-27
- Clinical Trial Shows Device Optimizes Cardiac Resynchronization Therapy in Less Than Two Minutes; St. Jude Medical Announces QuickOpt Optimization Clinical Trial Results and European Regulatory Approvals at Cardiostim 2006
- ST. PAUL, Minn. -- St. Jude Medical, Inc. (NYSE:STJ) today announced the clinical trial results, receipt of European CE Mark approval and European market launch of its QuickOptTM Timing Cycle Optimization. The trial results were presented by James G. Porterfield, M.D., principal investigator in the trial conducted under a U.S....
- Research articles 2006-06-16
- Harvest Technologies Announces FDA Approval to Begin the First Randomized, Placebo-Controlled Clinical Trial in the United States Using Autologous Adult Stem Cells to Treat Patients With End-Stage Critical Limb Ischemia
- Harvest Technologies Corp. ( www.harvesttech.com ) announced today that the Food and Drug Administration FDA has granted Investigational Device Exemption IDE approval to commence a 48-patient 'feasibility' clinical trial using the company's BMAC System to treat patients with Critical Limb Ischemia CLI. The BMAC System is a point-of-care device...
- Research articles 2007-05-29
- New Low Profile Optional Vena Cava Filter Receives Conditional FDA Approval to Begin U.S. Clinical Trial
- CONSHOHOCKEN, Pa. -- Rex Medical, L.P., today announced that it has received an Investigational Device Exemption IDE from the U.S. Food and Drug Administration to begin a U.S. clinical trial for the Option[TM] Retrievable Vena Cava Filter in the prevention of recurrent Pulmonary Embolism PE.
- Research articles 2006-11-06
- Novoste Receives FDA Approval to Initiate Arterial-Venous Dialysis Graft Stenosis Clinical Trial
- Health/Medical Writers NORCROSS, Ga.--BW HealthWire--June 21, 2002 Novoste Corporation (Nasdaq: NOVT) today announced that it has received Investigational Device Exemption IDE approval from the U.S. Food and Drug Administration to begin its BRAVO (Beta Radiation for treatment of Arterial-Venous graft Outflow) clinical trial. Over 200,000 people in...
- Research articles 2002-06-21
- Lenstec Receives FDA Clearance to Begin Clinical Trial of Softec HD IOL
- AAO Annual Meeting -- Lenstec, Inc. -- a provider of technologically advanced lens implants and devices used in cataract and refractive surgery -- today announced that the U.S. Food and Drug Administration has granted the company an Investigational Device Exemption IDE to begin a clinical trial of the Softec HD...
- Research articles 2006-11-13
- ViaCell Receives IDE Supplement Approval to Advance ViaCyte Pivotal Trial
- CAMBRIDGE, Mass. -- ViaCell, Inc. (Nasdaq: VIAC) announced today that it has received FDA approval of its investigational device exemption IDE supplement for its ViaCyteSM pivotal clinical trial. The pivotal study will evaluate ViaCyte, an investigational product being studied for the cryopreservation and thawing of human oocytes for use during...
- Research articles 2007-07-09
- CVRx®, Inc., Receives IDE Approval for Rheos™ Baroreflex Hypertension Therapy™ System Pivotal Trial
- MINNEAPOLIS -- CVRx([R]), Inc., a private medical device company that has developed an implantable medical device to treat high blood pressure, has received a conditional investigational device exemption IDE approval from the U.S. Food and Drug Administration FDA to begin a U.S. pivotal clinical trial that will evaluate the safety...
- Research articles 2006-10-16
- Lipid Sciences, Inc. Receives Conditional Approval From the FDA of Investigational Device Exemption (IDE) Application
- Lipid Sciences, Inc. (NASDAQ: LIPD) today reported that it had received conditional approval for the Company's Investigational Device Exemption IDE application from the Center for Devices and Radiological Health of the Food and Drug Administration FDA to begin a human clinical trial of the Company's Plasma Delipidation System-2 (PDS-2). The...
- Research articles 2006-01-31
- bioLytical Receives FDA Clearance to Initiate Clinical Trial for 60-Second HIV Test.
- VANCOUVER, BRITISH COLUMBIA, Jul 10, 2007 CCNMatthews via COMTEX -- bioLytical Laboratories bioLytical announced today the U.S. Food and Drug Administration FDA has accepted the Investigational Device Exemption IDE application for INSTITM, VANCOUVER, BRITISH COLUMBIA, Jul 10, 2007 CCNMatthews via COMTEX -- bioLytical Laboratories...
- Research articles 2007-07-10
- Medtronic Receives FDA Approval to Study INFUSE Bone Graft in the Cervical Spine
- MEMPHIS, Tenn. -- Medtronic, Inc. (NYSE:MDT) announced today that the U.S. Food and Drug Administration FDA has granted an investigational device exemption IDE to conduct a clinical trial to study INFUSEr Bone Graft in a cervical spinal fusion. The investigational device will consist of INFUSE Bone Graft inside a polyetheretherketone...
- Research articles 2006-10-09
- Lipid Sciences, Inc. Files Investigational Device Exemption (IDE) Application With the FDA
- Lipid Sciences, Inc. (NASDAQ: LIPD) today reported that it has filed an Investigational Device Exemption IDE application with the Center for Devices and Radiological Health of the Food and Drug Administration FDA. The FDA will be evaluating the completeness of this submission to determine if and when Lipid Sciences...
- Research articles 2005-12-29
- ViaCell Expands Study Sites in ViaCyte Pivotal Trial
- CAMBRIDGE, Mass. -- ViaCell, Inc. (Nasdaq: VIAC) today announced it expects to expand the number of U.S. clinical sites participating in its ViaCyteSMpivotal trial from three to eight. ViaCyte is an investigational product intended to broaden reproductive options for women through the freezing and thawing of human oocytes eggs. The...
- Research articles 2007-08-22
- BIOTRONIK receives IDE approval to start the Phylax 06 clinical study
- LAKE OSWEGO, Ore.--BUSINESS WIRE--Dec. 18, 1996--BIOTRONIK Inc. announced today the initiation of the Phylax 06 implantable cardioverter defibrillator ICD clinical trial following rapid approval of their IDE submission by the FDA. The submission includes the Phylax 06 ICD as well as the SL-ICD single-pass lead system. ...
- Research articles 1996-12-18
- FDA Approves Clinical Trial for Medtronic's DIAM™ Spinal Stabilization System
- MEMPHIS, Tenn. -- Medtronic, Inc. (NYSE:MDT) announced today that the U.S. Food and Drug Administration FDA has granted an investigational device exemption IDE to the DIAMTM Spinal Stabilization System for use in a clinical study. This approval will allow Medtronic to begin the first of three planned clinical trials in...
- Research articles 2006-07-10
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