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23 Resources for

fda and ide

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Spinal Restoration, Inc. Receives FDA IDE Approval: AUSTIN, Texas -- Spinal Restoration, Inc. announced today that the U.S. Food and Drug Administration has approved an Investigational Device Exemption IDE pilot study of the Biostat([R])Disc Augmentation System. Enrollment in the 15 patient pilot study is expected to begin at three clinical sites in July.; Tags: FDA, IDE; Research articles 2008-05-13
Imaging3 Receives FDA Approval to Distribute the Dominion Vi Scanner Under FDA (IDE) Regulations: Imaging3TM, Inc. (OTCBB: IMGG), developer of a breakthrough medical imaging device that produces 3D medical diagnostic images of virtually any part of the human body in real-time, today provided insight into the Company's progress with the FDA. "This is a very important step in the FDA 510k approval process...; Tags: FDA, IDE; Research articles 2008-04-02
FDA Approves Abiomed's IDE for IMPELLA 5.0 Minimally Invasive Cardiac Support Systems; Advanced Medical Technology Indicated for Use with Low Cardiac Output after Cardiac Surgery: DANVERS, Mass. -- Abiomed, Inc. (NASDAQ: ABMD) today announced conditional approval by the U.S. Food and Drug Administration FDA of its Investigational Device Exemption IDE for the IMPELLA 5.0 unique, catheter-based Circulatory Support Systems. Clinical trials in the U.S. are to begin immediately. The IMPELLAR RECOVER 5.0 devices are already...; Tags: FDA, IDE; Research articles 2006-06-27
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...; Tags: FDA, IDE; Research articles 2006-10-16
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...; Tags: FDA, IDE; Research articles 2007-07-09

Influence announces Investigational Device Exemption - IDE - and grant of expedited review for the In-Flow incontinence product by FDA: SAN FRANCISCO--BW HealthWire--May 21, 1997--Influence Inc. announced that the U.S. Food and Drug Administration FDA has granted Investigational Device Exemption IDE for the company's In-FlowTM remote-controlled intraurethral valve-pump catheter.; Tags: FDA, IDE; Research articles 1997-05-21
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/ --; Tags: clinical trial, FDA, IDE; Research articles 2006-05-09
Cook Incorporated Files IDE Application for Zenith Branch Vessel Graft with U.S. FDA: BLOOMINGTON, Ind. -- Cook Incorporated, the world leader in endovascular repair of aortic disease, has filed an Investigational Device Exemption IDE for a new type of endograft designed to treat patients with aortoiliac or iliac aneurysms that have been difficult to treat endovascularly with currently available designs.; Tags: FDA, IDE; Research articles 2008-01-24
FDA Approves Further Changes To CORTOSS® IDE Pivotal Study Protocol: MALVERN, Pa. -- Orthovita, Inc.; Tags: FDA, IDE, Pivotal Corp.; Research articles 2006-04-17
Cardima, Inc. Receives FDA Approval of IDE for Initial Phase of Atrial Fibrillation Study: FREMONT, Calif.--BW HealthWire--July 9, 1997--Cardima, Inc., (NASDAQ:CRDM) announced today that the FDA had approved the Company's investigational device exemption IDE submission to begin its initial atrial fibrillation AF study in the United States for the Cardima Pathfinder microcatheter system.; Tags: FDA, IDE; Research articles 1997-07-09
Sofamor Danek Receives Conditional Approval From Fda For Threaded Interbody Fusion Device Ide: MEMPHIS, Tenn.--BUSINESS WIRE--March 24, 1995--Sofamor Danek Group, Inc. (NYSE:SDG) today announced that it has received conditional approval from the Food and Drug Administration FDA to begin an investigational device exemption IDE multicenter study on the Threaded Interbody Fusion Device TIBFD. The conditional approval is limited to investigational use of...; Tags: Company, FDA, IDE; Research articles 1995-03-24
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.; Tags: clinical trial, FDA, IDE; Research articles 1996-05-21
EP MedSystems Files Alert System IDE With FDA: BUDD LAKE, N.J.--BUSINESS WIRE--Aug. 21, 1997--; Tags: FDA, IDE; Research articles 1997-08-21
Angiotech Pharmaceuticals: Boston Scientific Submits IDE to FDA for U.S. Clinical Trial of its Paclitaxel-Eluting Coronary Stent System: Business Editors; Tags: Boston Scientific Corp., FDA, IDE; Research articles 2001-10-25
Angiotech Pharmaceuticals: Boston Scientific Submits Amended IDE to FDA for U.S. Clinical Trial of Its Paclitaxel-Eluting Coronary Stent System: Business Editors & Health/Medical Writers; Tags: Boston Scientific Corp., FDA, IDE; Research articles 2002-02-20
EndoSonics Submits IDE Application to the FDA for Directional Brachytherapy Device; Cleveland Clinic Foundation is Development Partner: Business Editors and Medical/Health Writers; Tags: FDA, IDE; Research articles 2000-03-28
Angiotech Pharmaceuticals: Boston Scientific Submits Amended IDE to FDA for U.S. Clinical Trial of its Paclitaxel-Eluting Coronary Stent System.: VANCOUVER, BRITISH COLUMBIA, FEBRUARY 20, 2002 VANCOUVER, BRITISH COLUMBIA, FEBRUARY 20, 2002; Tags: Boston Scientific Corp., FDA, IDE; Research articles 2002-02-20
Outpatient Procedure for Asthma; Asthmatx Announces the Start of its FDA Approved IDE Study that may Change the Course of Asthma Care: MOUNTAIN VIEW, Calif. -- Asthmatx, Inc. today announced the start of its Asthma Intervention Research 2 (AIR2) Trial of its catheter-based investigational procedure that may change the standard of care for millions of asthma sufferers.; Tags: asthma, FDA, IDE; Research articles 2006-01-09
Angiotech Pharmaceuticals: Boston Scientific Submits IDE to FDA for U.S. Clinical Trial of its Paclitaxel-Eluting Coronary Stent System; Trial is Company's Fourth.: NATICK, MASSACHUSETTS, OCTOBER 25, 2001 NATICK, MASSACHUSETTS, OCTOBER 25, 2001; Tags: Boston Scientific Corp., FDA, IDE; Research articles 2001-10-25
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.; Tags: clinical trial, FDA, IDE; Research articles 1997-02-11