EnteroMedics (ETRMD) Completes VBLOC Therapy Pre-PMA Meeting With FDA
5/17/2013
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Inx Medical Raises $700,000, Seeks FDA Approval for Device
5/9/2013
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FDA Grants Premarket Approval (PMA) for the SEDASYS® System For Healthy Patients Undergoing Sedation During Routine Colonoscopy and EGD Procedures
5/6/2013
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FDA Panel Votes in Favor of Allergan Inc. (AGN)'s Juvederm Voluma XC Facial Filler
5/3/2013
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Delcath Systems, Inc. (DCTH) Hit With Another FDA Setback
5/1/2013
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FDA Delays Approval of Titan Pharmaceuticals (TTP)'s Suboxone Implant
5/1/2013
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Cerus Corporation (CERS) Announces FDA Agreement on Modular Premarket Approval (PMA) Application Submission Process for INTERCEPT Platelets
4/24/2013
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BioFire Diagnostics, Inc Submits 510(k) Application to FDA for FilmArray® Blood Culture Identification Test
4/17/2013
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Aethlon Medical (AEMD) (AEMD) Note: New Government Contract, Resubmission of IDE to Treat Hepatitis C (HCV), Biothreat Legislation Signed into Law by President Obama
4/16/2013
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FDA Panel Recommends Approval for Bausch & Lomb's Trulign Toric Eye Implant
4/9/2013
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Seventh Sense Biosystems Inc. Announces Initiation of Registration Trial for Painless TAP™ Blood Collection Device
4/2/2013
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GE Healthcare Submits Application to European Medicines Agency for Its Own Manufacturing of Optison™ 0.19 mg/ml Dispersion for Injection (Human Albumin Microspheres Containing Perflutren)
3/29/2013
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pSivida Corp (PSDV) Takes Another Stab at FDA Approval for Iluvien
3/27/2013
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Piramal Imaging Announces the Acceptance for Review of [18F] Florbetaben by the FDA and European Medicines Agency for the Visual Detection of Beta-Amyloid in Alzheimer's Disease
3/21/2013
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FDA Staff Does Not Recommend Approval of Abbott Laboratories (ABT) Heart Device
3/19/2013
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CellAegis Devices Inc. Receives Marketing Authorization From Health Canada for the AutoRIC™ Device to Provide Non-Invasive Remote Ischemic Conditioning (RIC)
3/7/2013
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Epigenomics AG Receives Notification of Priority Review Status and Acceptance for Filing by FDA of PMA Application for Epi proColon®
2/21/2013
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EDAP TMS S.A. (EDAP) Submits U.S. FDA Pre-Market Approval Application for Ablatherm®-HIFU for Treatment of Low Risk, Localized Prostate Cancer
2/1/2013
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Second Sight's First Bionic Eye for U.S. Market Awaits Approval From FDA
1/29/2013
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Alimera Sciences (ALIM)' ILUVIEN® Receives Marketing Authorization in Spain for the Treatment of Chronic Diabetic Macular Edema
1/17/2013
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GE Healthcare Announces Acceptance of Applications for Review of Investigational Imaging Agent [18F]Flutemetamol in the United States and Europe
1/8/2013
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Epigenomics AG Submits the Fourth Module and Completes Its PMA Submission to the FDA for Epi proColon®
1/7/2013
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Aethlon Medical (AEMD) Discloses Submission of Hepatitis C Virus (HCV) IDE to FDA
1/3/2013
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Venaxis, Inc. (APPY) Files for CE Approval for APPY1 in Europe
12/21/2012
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Cerus Corporation (CERS) Announces FDA Agreement on Modular Premarket Approval Application (PMA) Submission Process for INTERCEPT Plasma
12/13/2012
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EXACT Sciences Corporation (EXAS) Submits First Module of Premarket Approval Application to FDA
12/11/2012
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FzioMed Inc. Files Citizen Petition for Reconsideration Following FDA Rejection of Its Spinal Gel PMA
12/7/2012
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Given Imaging Ltd. (GIVN) Submits PillCam® COLON 2 Application to FDA for U.S. Regulatory Clearance
11/27/2012
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Sunshine Heart Receives Unconditional FDA Approval for C-Pulse® System's U.S. Pivotal Trial
11/21/2012
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Dune Medical Devices Ltd. Receives Approvable Letter From FDA for the MarginProbe® System
11/19/2012
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VisionCare Ophthalmic Technologies Receives Health Canada License for First-Ever Telescope Prosthesis for End-Stage Macular Degeneration
11/8/2012
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Paragonix Technologies Inc. Announces Filing of a 510(k) Pre-Marketing Notification Application With the FDA for the Paragonix Sherpa™ Cardiac Transport System
11/6/2012
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Cohera Medical, Inc. Receives Approval for First Module of Its Premarket Approval Application (PMA) for TissuGlu® Surgical Adhesive
10/30/2012
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FDA Panel Votes to Expand PMA for Hologic, Inc. (HOLX)'s Mammography System
10/29/2012
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NuVasive, Inc. (NUVA) Announces PMA Approval of the PCM(R) Cervical Disc System
10/26/2012
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On-X Life Technologies, Inc. Submits for FDA/CE Approval of Reduced Anticoagulation Indication for On-X Aortic Heart Valve
10/22/2012
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Delcath Systems, Inc. (DCTH) Clears Important FDA Hurdle
10/17/2012
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Coaxia Inc. Wins FDA Panel Date for Cerebral Ischemia Device
10/12/2012
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iSonea Limited Files FDA Submission for Over-the-Counter SonoSentry™
10/3/2012
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Sunshine Heart Announces Conditional Approval of IDE From the FDA for C-Pulse® Heart Assist System
10/1/2012
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FDA Recommends Approval for Second Sight's Argus® II Retinal Prosthesis System
10/1/2012
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AEterna Zentaris (AEZS) Provides Update on NDA Filing for AEZS-130 as Diagnostic Test for Adult Growth Hormone Deficiency
9/26/2012
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Southern California Medical Device Maker Dallen Medical Files for FDA Clearance
9/25/2012
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Bal Seal Engineering, Inc.: Market Growth Spurs New Hire, MEDTEC China Presence
9/20/2012
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MolecularMD and Ariad Pharmaceuticals, Inc. (ARIA) Announce Voluntary Withdrawal of MolecularMD's Premarket Approval Application for BCR-ABL T315I Mutation Test
9/18/2012
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FDA Rejects Navidea Biopharmaceuticals (NEOP)' Tracing Agent Lymphoseek
9/12/2012
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Nomir Medical Announces 510(k) Application to FDA for the Temporary Increase of Clear Nail in Patients With Onychomycosis (Toenail Fungus) With the Noveon™ Laser
9/5/2012
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Biosign Technologies Inc. Files FDA Premarket 510(k) Notification for UFIT TEN-10 "Automated Wrist Blood Pressure Monitor"
8/13/2012
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AspenBio Pharma, Inc. Submits Pre-IDE Information Package to FDA for AppyScore™ Appendicitis Test System
8/7/2012
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Philosys Anticipates FDA Approval for New Gmate® Blood Glucose Monitoring System
8/3/2012
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MolecularMD Submits Premarketing Approval Application to the FDA for Its BCR-ABL T315I Mutation Test, a Companion Diagnostic to Ponatinib, an Investigational BCR-ABL Inhibitor
7/31/2012
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Anaxsys Files 510(k) for respiR8™ Continuous Respiratory Rate Counter
7/25/2012
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Guided Therapeutics, Inc. and FDA Agree on Plan for LuViva® Advanced Cervical Scan PMA
7/25/2012
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BioMimetic Therapeutics, Inc. (BMTI) Submits Augment®Bone Graft PMA Amendment to FDA
7/10/2012
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FDA Approves Beckman Coulter, Inc. (BEC)'s New Blood Test to Improve Prostate Cancer Detection
6/26/2012
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FDA Rejects Repligen Corporation (RGEN)'s Imaging Agent, Shares Drop
6/22/2012
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Kelyniam Global Files 510k for Custom Craniofacial Implants & Closes Financings
6/20/2012
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Roche (RHHBY) Submits TnT-hs Assay for FDA Clearance on Cobas Immunoassay, Elecsys Analyzers
6/8/2012
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Chembio Diagnostics, Inc. (CEMI.OB) Files Final Module of Premarket Approval Application With FDA for DPP(R) Point-of-Care HIV 1/2 Rapid Test
6/7/2012
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Allied Healthcare Group Files for CE Mark for Heart Patch
6/6/2012
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FDA Panel Backs OraSure Technologies, Inc. (OSUR)'s First at Home HIV Test
5/16/2012
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U-Systems Receives FDA PMA Approvable Letter for Somo•v Automated Breast Ultrasound (ABUS) System
5/14/2012
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Guided Therapeutics, Inc. Submits Response to FDA for LuViva® Advanced Cervical Scan PMA
5/9/2012
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SANUWAVE, Inc. Receives Conditional Approval from the FDA on Clinical Trial Plan for dermaPACE
5/8/2012
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FDA Panel Backs Cameron Health's Heart Defibrillator
4/27/2012
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HeartWare (HTWR) Soars as FDA Panel Backs Implantable Pump
4/26/2012
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Diatron to Offer Advanced Hematology Analyzer in the U.S.
4/24/2012
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FDA Panel Scheduled to Review Edwards Lifesciences Corporation (EW) Sapien Valve for High-Risk Patients on June 13
4/9/2012
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Dune Medical Devices Ltd.'s Breast Cancer Device Gets a Date With the FDA
4/6/2012
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Cameron Health’s S-ICD® System Scheduled for FDA Panel Review on April 26, 2012
3/19/2012
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HeartWare Announces Date for FDA Advisory Committee Panel
2/14/2012
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NeurogesX, Inc. (NGSX) Sinks Some More After FDA Panel Votes Against HIV Pain Patch
2/10/2012
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ETView Medical, Ltd. Announced Filing of a 510(k) Pre-Marketing Notification Application with the US FDA for the Viva™ EB Line of Innovative Endobronchial Blockers
2/6/2012
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MindChild Medical, Inc. Files FDA Application for Fetal Heart Monitor
2/6/2012
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VuCOMP Receives Premarket Approval for Mammography Computer-Aided Detection System
2/3/2012
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Idaho Technology Inc. Seeks FDA Clearance for the Expanded FilmArray® Respiratory Panel
1/31/2012
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InSightec Submits Pre Market Application (PMA) for FDA Approval of ExAblate for Treatment of Painful Bone Metastases
1/24/2012
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Guided Therapeutics, Inc. Provides Update on PMA Application for LuViva® Advanced Cervical Scan and Timing for Filing of CE Mark
1/23/2012
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Uromedica, Inc. Fighting for FDA Approval
1/13/2012
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LipoScience, Inc. Submits FDA 510(K) for Vantera® Clinical Analyzer
1/5/2012
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BioMimetic Therapeutics, Inc. (BMTI) Receives Augment® Bone Graft PMA Response Letter from FDA
1/4/2012
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OraSure Technologies, Inc. (OSUR) Makes Final FDA Submission for Approval of Over-the-Counter Rapid HIV Test
1/3/2012
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GenMark Diagnostics (GNMK) Submits Respiratory Viral Panel Test for FDA 510(k) Clearance
12/22/2011
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SANUWAVE, Inc. Updates on FDA Review of dermaPACE Premarket Approval Application
12/22/2011
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ETView Medical, Ltd. Announced Filing of a 510(k) Pre-Marketing Notification Application with the FDA for the VIVASIGHT™ DL Line of Innovative Airway Management Devices
12/12/2011
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FDA Panel Votes Against CardioMEMS Device
12/9/2011
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Steris Corporation (STE) Still Awaiting FDA Clearance of Key Accessory to System 1E Device
11/15/2011
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Great Basin Corporation Submits 510(K) Application to FDA for C. Difficile Molecular Diagnostic Test
11/14/2011
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U-Systems' Automated Breast Ultrasound Premarket Approval Application for Breast Cancer Screening Accepted for FDA Review
11/10/2011
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Guided Therapeutics, Inc. Reports Update on FDA Review of LuViva(TM) Advanced Cervical Scan PMA Application
11/2/2011
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Guided Therapeutics, Inc. Reports Update on FDA Review of LuViva™ Advanced Cervical Scan PMA Application
11/2/2011
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Boston Biomedical Associates Helps AtriCure, Inc. (ATRC) 's Synergy Ablation System Win a Recommendation from FDA Expert Advisors
10/28/2011
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FDA Advisers Reject Medtronic, Inc. (MDT) Heart Device
10/28/2011
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FDA Advisors: AtriCure, Inc. (ATRC) Device Effective for afib; Stock Rises +1.82 (18.20%) @ 11:21AM EDT
10/27/2011
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Contura's Aquamid Wrinkle Filler Hits Regulatory Bump
10/21/2011
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Neoprobe Corporation (NEOP) Receives FDA Acceptance of Lymphoseek(R) (tilmanocept) New Drug Application
10/20/2011
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Chembio Diagnostics, Inc. (CEMI.OB) Files PMA Module II With FDA for DPP(R) HIV Test
10/3/2011
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Mela Sciences (MELA) Receives Approvable Letter From FDA for MelaFind(R)
9/26/2011
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ALR Technologies Inc. Filed Response to Most Recent FDA Questions on 510(k) for the ALRT Health-e-Connect (HeC) System
9/26/2011
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Cook Medical Gets Panel Date for Zilver
9/13/2011
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ZYTO Corp. Announces Approval of Its 510(k) Filing With the ZYTO Corp.
9/8/2011
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Repligen Corporation (RGEN) Seeks Approval for Imaging Product While Pursuing Rare-Disease Drugs and Manufacturing Platform
9/2/2011
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Kalypto Medical Seeks 510(k) Ban for Smith & Nephew Inc.'s Wound Device
8/22/2011
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Nephros Inc. (NEP) Files 510(k) Application for Hemodiafiltration System
8/12/2011
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Ortho-Tag Seeks FDA Approval for System that IDs Surgical Implants
8/1/2011
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Roche (RHHBY) Submits Acute Hepatitis B Test to FDA for Premarket Approval
7/26/2011
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Bio-Rad Laboratories, Inc. (BIO) Receives FDA Premarket Application Approval for Its Fourth-Generation HIV Assay
7/25/2011
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SANUWAVE Health Submits Final Module of PMA Application for FDA Approval of dermaPACE to Treat Diabetic Foot Ulcers
7/6/2011
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Chembio Diagnostics, Inc. (CEMI.OB) Initiates Pre-IDE Studies for Home Use of Sure Check(R) Rapid HIV Test
6/27/2011
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D. Medical Industries Ltd. (DMED) Submits CE Mark Approval Application for "Spring Zone" Durable Insulin Pump
6/24/2011
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FDA Advisory Panel to Review Edwards Lifesciences Corporation (EW) SAPIEN Valve on July 20
6/7/2011
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FDA Approves Review of Dune Medical Devices Ltd.'s Medical Breast Cancer Device
5/19/2011
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FDA Formally Accepts Dune Medical Devices Ltd.'s MarginProbe(TM) System Pre-Market Approval (PMA) Application and Grants Expedited Review Status
5/16/2011
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Hansen Medical Submits 510(k) Application With U.S. FDA for Vascular Robotic System and Catheter
4/11/2011
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Oceana Therapeutics Gets FDA Approvable Letter for Solesta(R), a Significant Treatment Option for Fecal (Bowel) Incontinence; the Only Minimally Invasive Therapy for More Severe Bowel Control Problems
4/7/2011
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DNA Genotek Submits Filing for 510(k) Clearance
3/15/2011
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Mela Sciences Release: Company Files MelaFind(R) PMA Amendment With U.S. FDA
3/2/2011
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Dynatronics Corporation (DYNT) Named Contract Supplier to Amerinet, Inc.'s 50,000 Members
1/27/2011
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Celera Corporation (CRA) Files U.S. Regulatory Application for KIF6 Genotyping Assay
1/3/2011
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HeartWare Files PMA Application for FDA Approval of the HeartWare(R) Ventricular Assist System for a Bridge-to-Transplant Indication
12/28/2010
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SANUWAVE, Inc. Health Submits to FDA First Module of PMA Application for dermaPACE for the Treatment of Diabetic Foot Ulcers
12/10/2010
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Neoprobe Corporation (NEOP) Granted Pre-IND Meeting with FDA to Review RIGS Technology
12/9/2010
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FDA Accepts Guided Therapeutics, Inc.' Non-Invasive Cervical Cancer Scanner PMA Application for Review
12/2/2010
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Imaging Diagnostic Systems (IMDS) Announces Filing of 510(k) Submission to FDA
11/23/2010
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Tenaxis Medical, Inc. Announces 'Fileable' Status of PMA
10/26/2010
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Neoprobe Corporation (NEOP) Lymphoseek Pre-NDA Meeting
10/7/2010
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Guided Therapeutics, Inc. Files Premarket Approval Application for Non-Invasive Cervical Cancer Scanner with FDA
9/27/2010
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Cook Medical Files Pre-Market Approval Application for FDA Approval of A Balloon Expandable Stent for Renal Artery Disease
9/24/2010
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Gen-Probe Incorporated (GPRO) Files US Regulatory Application for PROGENSA(R) PCA3 Assay, New Molecular Test to Help Determine Need for Repeat Prostate Biopsies
9/22/2010
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BioMimetic Therapeutics, Inc. (BMTI) PMA Remains on Track
9/8/2010
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Arrayit Corporation Announces Premarket Approval (PMA) Submission Strategy for OvaDx(R)
8/23/2010
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INVO Bioscience Commences Registration Process for INVOCell Fertility Device in China
8/10/2010
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Bio-Rad Laboratories, Inc. (BIO) Submits Premarket Approval Application to the FDA for Its Fourth-Generation HIV Assay
7/26/2010
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Candela (CLZR) Achieves Approval to Market Its Vbeam(R) Lasers in Japan
7/19/2010
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NeuroPace, Inc. Submits PMA Application for FDA Approval of Novel Investigational Device for Epilepsy
7/8/2010
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IRIS International, Inc. (IRIS) Submits 510(k) Application to FDA for iChem(R)VELOCITY(TM) Automated Urine Chemistry Analyzer and iRICELL(R) Urinalysis Workstation
7/1/2010
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BioMimetic Therapeutics, Inc. (BMTI) Receives Filing Letter from FDA for Augment(TM) Bone Graft PMA
6/29/2010
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BioMimetic Therapeutics, Inc. (BMTI) Receives Filing Letter from FDA for Augment(TM) Bone Graft PMA
6/28/2010
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University of Arkansas for Medical Sciences Study: Device Uses Fingerprints To Track Children's Data
6/25/2010
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Cephalon, Inc. (CEPH) Partners with American Chronic Pain Association and the American Pharmacists Association to Expand National Initiative On the Safe and Appropriate Use of Prescription Medicines
6/23/2010
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BSD Medical (BSDM) Exhibits MicroThermX(R) Microwave Ablation System at World Conference on Interventional Oncology
6/23/2010
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Cook Medical Files PMA Submission for FDA Approval of Zilver(R) PTX(R) Drug-Eluting Stent Platform
6/15/2010
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Cook Medical Files Pre-Market Approval Application for FDA Approval of Zilver(R) PTX(R) Drug-Eluting Stent Platform
6/11/2010
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Roche Diagnostics Corporation (ROG.VX) Receives FDA Approval for Qualitative Anti-HCV Immunoassay Test on Three Analyzer Platforms
5/28/2010
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Mela Sciences Announces FDA Panel to Review MelaFind(R) PMA Application on August 26, 2010
5/26/2010
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ev3 Inc. (EVVV) Files PMA Application for FDA Approval of Pipeline Embolization Device
5/18/2010
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PolyTouch Medical Ltd. Announces the Submission of a Premarket Application for PatchAssist
5/3/2010
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Contura Submits Registration Application for Aquamid(R) to the FDA
4/15/2010
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FDA Accepts Filing of Ondine Biopharma Corporation's Pre-Market Approval (PMA) Application for Periowave(TM) Photodisinfection System
3/17/2010
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Vertos Medical Inc.'s Prospective Outcomes Study Demonstrates Efficacy, Validates Safety Profile of mild(R)
3/12/2010
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BioMimetic Therapeutics, Inc. (BMTI) Completes Submission of PMA Application for FDA Approval of Augment(TM) Bone Graft
2/18/2010
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BioElectronics Corporation Files Application with FDA for Reclassification – Company to File PMA Application
1/19/2010
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OraSure Technologies, Inc. (OSUR) Files Additional Data With FDA in Support of PMA Application for OraQuick Rapid HCV Test
1/7/2010
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Ondine Biopharma Corporation Files PMA Submission for Periowave(TM) Photodisinfection System
1/7/2010
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AMICAS, Inc. (AMCS) Agrees To $217 Million Buyout By Private-Equity Firm Thoma Bravo
12/28/2009
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Organogenesis Inc. Files PMA for CelTx(TM) for Oral Soft Tissue
12/21/2009
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SpinalMotion Submits Lumbar Disc PMA
11/12/2009
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BioElectronics Corporation Files With FDA for OTC Pre-Marketing Clearance
9/22/2009
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BioElectronics Corporation Files With FDA for OTC Pre-Marketing Clearance
9/22/2009
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Merz Pharmaceuticals, LLC's Belotero(R) Balance PMA Filing Formally Accepted for Review by the FDA
9/11/2009
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Q-Med AB And Smith & Nephew plc (SNN) Takes Durolane(TM) PMA In USA To Next Stage
8/20/2009
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FDA Accepts Electro-Optical Sciences, Inc.'s MelaFind(R) Pre-Market Approval (PMA) Application for Review
8/4/2009
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Medtronic, Inc. (MDT) Files Pre-Market Approval Application for FDA Approval of Deep Brain Stimulation for Treatment-Resistant Epilepsy
7/16/2009
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BioMimetic Therapeutics, Inc. (BMTI) Submits First Two PMA Modules to FDA
6/18/2009
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DxNA Submits its Rapid Detection Platform Test for H1N1 to FDA
6/9/2009
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Electro-Optical Sciences, Inc. Submits MelaFind(R) Pre-Market Approval Application to FDA
6/4/2009
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Genomic Health, Inc.'s Oncotype DX(R) Colon Cancer Test Predicts Individualized Recurrence Risk for Stage II Colon Cancer Patients
5/15/2009
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NMT Medical, Inc (NMTI) Receives PMA Approval for STARFlex as a Ventricular Septal Defect Repair Implant
4/9/2009
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Innocoll, Inc. Files 510 (k) Application for CollaRx Lidocaine Sponge
3/31/2009
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FDA Advisory Panel Recommends Approval of VisionCare Ophthalmic Technologies' Implantable Telescope for End-Stage Macular Degeneration
3/31/2009
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Small Bone Innovations, Inc.’s S.T.A.R. Total Ankle Replacement System Receives FDA Approvable Letter
3/4/2009
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Steris Corporation (STE) Submits New Sterilization System To FDA and Announces Developments on SYSTEM 1 Warning Letter
1/20/2009
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Medicsight (MSHT.OB) Receives Additional Information Request for FDA 510(k) Clearance
1/20/2009
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Asthmatx, Inc. Seeks FDA Approval of New Device-Based Procedure for Severe Asthma
1/12/2009
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Myriad Genetics, Inc. (MYGN) Launches Sixth Personalized Medicine Product, Prezeon -- to Reveal PTEN Status
12/22/2008
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Guided Therapeutics, Inc. Submits First Module of Premarket Approval Application for Painless Cervical Cancer Detection to FDA
12/10/2008
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FDA Advisory Panel Discusses Application of Collagen Scaffold for Meniscal Injuries
11/20/2008
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Hologic, Inc. (HOLX) Cervista(TM) HPV Clinical Trial Met Or Exceeded All Of The Target End Points
11/14/2008
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OccuLogix Inc. (OCCX) Submits 510(k) Premarket Notification for the Tearlab(TM) Osmolarity System
10/29/2008
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Revolutions Medical Corporation Files Pre Market 510K Application with the FDA for 3cc Rev Vac Safety Syringe
10/28/2008
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Medtronic, Inc. (MDT) Submitted Pre-Market Approval Application For FDA Approval of InterStim(R) Therapy for Fecal Incontinence
10/22/2008
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Medicis (MRX) Announces FDA Approval of PMA Supplement for RESTYLANE
10/10/2008
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CDRH Update: PMA Final Decisions Rendered for July 2008
8/25/2008
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Atritech, Inc. Files Pre-Market Approval Application for Its WATCHMAN(R) LAA Closure Technology Enrolls first patient in Continued Access Registry
8/18/2008
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Emergency Filtration Products Inc. (EMFP.OB) Receives FDA Pre-market Notification for NanoMask(TM)
8/15/2008
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Oxford Immunotec Limited T-Spot(R). TB Gains FDA Premarket Approval
8/1/2008
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FzioMed Inc. Disagrees with Advisory Panel’s Recommendation to FDA Regarding Oxiplex® Gel
7/18/2008
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FDA Orthopaedic and Rehabilitation Devices Panel Rejects PMA Application for Spine Anti-Adhesion Gel by 5-2 Vote
7/17/2008
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FDA (JOBS) OK's Invitrogen Corporation (IVGN) (JOBS) Genetic Test for Breast Cancer
7/8/2008
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Emphasys Medical to Present VENT Clinical Trial Data at ATS 2008
5/13/2008
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Third Wave Technologies, Inc. (TWTI) Completes FDA Submissions for Its Two HPV Products
4/28/2008
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Ethicon Endo-Surgery, Inc. Submits Application to FDA for Approval of the SEDASYS(TM) System
3/27/2008
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Synbiotics (SBIO) Announces Human Submission for FluDetect(R)
3/13/2008
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Laborie Medical Technologies Receives FDA Pre-Market Clearance for TETRA(TM)
3/10/2008
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The Female Health Company Announces FDA Acceptance for Review of Its FC2 Premarket Approval Application
2/6/2008
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TyRx Pharma Inc. Announces FDA 510(k) Clearance of the AIGIS(Rx)(TM) Cardiac Rhythm Medical Device (CRMD) Anti-Bacterial Envelope, an Innovative Mesh Envelope Designed to Immobilize and Reduce Bacterial Infection of a Pacemaker or Implantable Cardioverter Defibrillator (ICD) When Implanted in the Body
1/17/2008
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BSD Medical (BSDM) Receives Letter from FDA on BSD-2000 Submission
1/7/2008
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Medtronic, Inc. (MDT) (Jobs) Files PMA Application for FDA Approval of Talent(TM) Abdominal Stent Graft System
12/3/2007
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Imaging Diagnostic Systems (IMDS) Updates PMA Filing Status for the New CT Laser Breast Imaging System Secures 10th U.S. Clinical Site
11/28/2007
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Ortec International Inc. (ORTN.OB) Files PMA for OrCel(R) for VLU Indication
10/23/2007
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