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Medical Dev. & Diag. - Pre-Market Approvals (PMA)
Guided Therapeutics, Inc. Receives May 8th Meeting Date From FDA To Discuss Luviva® Advanced Cervical Scan PMA Application 4/10/2014  More...
Myriad Genetics, Inc. (MYGN) Submits Premarket Approval To FDA For Bracanalysis® 4/8/2014  More...
Stereotaxis, Inc. (STXS) Submits 510(K) Application To FDA For Vdrive™ With V-Loop™ System 4/1/2014  More...
VertiFlex Announces Submission Of Final PMA Module To The FDA, For The Superion® Interspinous Spacer System 4/1/2014  More...
FDA Panel Backs EXACT Sciences Corporation (EXAS)'s Cologuard 3/28/2014  More...
Guided Therapeutics, Inc. Submits Request For Face To Face Meeting With FDA; Receives Notification On PMA Extension For Luviva® Advanced Cervical Scan 3/27/2014  More...
Merck & Co., Inc. (MRK), Endocyte, Inc. (ECYT) Cancer Products Get Thumbs Up From EU Committee CHMP 3/21/2014  More...
EDAP TMS S.A. (EDAP) Completes FDA Q&A Session For Its Ablatherm-HIFU Pre-Market Approval Application 3/20/2014  More...
FDA Asks For More Data On Avedro, Inc.'s Eye Therapy System 3/19/2014  More...
FDA Panel Recommends Clearance For Immucor (BLUD) Blood-Typing Chip 3/19/2014  More...
AdvanDx, Inc. Announces FDA 510(K) Submission For Meca Xpressfish™ -- A New Method For Rapid Detection Of Methicillin-Resistant Staphylococcus Aureus (MRSA) From Positive Blood Cultures 3/18/2014  More...
FDA Advisory Committee: Roche (RHHBY)'s DNA Test Can Replace Pap Smear 3/13/2014  More...
Wright Medical Group, Inc. (WMGI) Announces Agreement With FDA Office Of Device Evaluation To File PMA Amendment For Augment® Bone Graft In Lieu Of Dispute Resolution Panel 3/11/2014  More...
AngioDynamics (ANGO) Win FDA Nod For DuraMax Dialysis Catheter 3/7/2014  More...
AngioDynamics (ANGO) Updates U.S. Tip Location Strategy 3/7/2014  More...
Atossa Genetics, Inc. (ATOS) Announces FDA Response to 510(k) Submission for ForeCYTE Breast Aspirator 3/4/2014  More...
FDA Wants More Info From Atossa Genetics, Inc. (ATOS) For Forecyte Breast Aspirator 3/4/2014  More...
BioFire Diagnostics, Inc Submits 510(k) Application To FDA For FilmArray® Gastrointestinal Panel 2/19/2014  More...
National Institute for Clinical Excellence (NICE) Gives Go Ahead To Neotract's Groundbreaking UroLift® Prostate Implant That Can Preserve Sexual Function While Offering Urinary Symptom Relief For Millions Of Men Affected By Enlarged Prostates 1/30/2014  More...
eNeura Therapeutics Files 510(K) With The FDA For Springtms® Migraine Treatment 1/27/2014  More...
Greatbatch, Inc. (GB) Requests CE Mark For Spinal Cord Stim 1/21/2014  More...
Echo Therapeutics (ECTE) Submits CE Mark Technical File For Its Symphony® CGM System 1/13/2014  More...
Encision, Inc. (ECIA) Files 510(K) With FDA For AEM ® Simplification Product 1/8/2014  More...
Sapheon, Inc. Submits Second Module Of PMA Application For VenaSeal® Sapheon Closure System; Raises $10M In Bridge Note Financing 1/7/2014  More...
LabStyle Innovations Files 510(K) In The U.S. For FDA Clearance Of The Dario™ Blood Glucose Monitoring System 1/7/2014  More...
Actavis (ACT) Denies FDA' Contraceptive Patch, Seeks More Data 12/30/2013  More...
Alimera Sciences (ALIM), pSivida Corp (PSDV) Rocket On FDA Labeling Talks For Eye Drug 12/20/2013  More...
Corgenix Medical Corporation (CONX) Announces Filing Of 510(k) Premarket Notification For FDA Clearance Of TxBCardio™ Assay 12/16/2013  More...
Boston Scientific Corporation (BSX)'s Anti-Stroke Device Wins FDA Panel's Blessing 12/12/2013  More...
Boston Scientific Corporation (BSX) May Face A Tough FDA Panel 12/11/2013  More...
Cerus Corporation (CERS) Submits Final Module In The Premarket Approval (PMA) Application Process For INTERCEPT Plasma 12/4/2013  More...
Epigenomics AG Announces FDA Advisory Committee Meeting To Review Epi proColon® 11/27/2013  More...
C.R. Bard Submits Final PMA Module To The FDA For The Lutonix Drug-Coated Balloon 11/26/2013  More...
Cohera Medical, Inc. Completes Fourth And Final Module In The Premarket Approval (PMA) Application For TissuGlu® Surgical Adhesive 11/19/2013  More...
Paragonix Technologies Inc. Announces Filing Of A Second 510(k) Pre-Marketing Notification Application With The US Food And Drug Administration For The Paragonix Sherpa™ Cardiac Transport System 11/18/2013  More...
Corgenix Medical Corporation (CONX) Files Concurrent de novo 510(k) Pre-Market Notification For FDA Clearance Of Its Hyaluronic Acid (HA) Test Kit 11/12/2013  More...
Boston Scientific Corporation (BSX)'s Anti-Stroke Watchman Heart Implant Lands A Date With The FDA 11/12/2013  More...
FzioMed Inc. Wins Independent Review of Oxiplex Gel 11/5/2013  More...
Advanced Medical Isotopes Corporation Files 510(k) Pre-Market Notification for FDA Clearance of Yttrium-90 RadioGel™ Brachytherapy Product 11/4/2013  More...
MiMedx Lands a Date With the FDA 10/18/2013  More...
FDA Advisory Panel Recommends Expanded Indication for Medtronic, Inc. (MDT) CRT Devices in Patients With AV Block and Reduced Heart Function 10/9/2013  More...
Cerus Corporation (CERS) Submits the First of Three Modules in the Premarket Approval (PMA) Application Process for INTERCEPT Platelets 10/1/2013  More...
Sapheon, Inc. Submits First Module of PMA Application for VenaSeal® Sapheon Closure System 9/20/2013  More...
FDA Ophthalmic Devices Panel Favorably Votes for the Ocular Therapeutix, Inc.'s Resure® Sealant 9/20/2013  More...
FDA Has More Questions About Guided Therapeutics, Inc.'s LuViva 9/10/2013  More...
Titan Pharmaceuticals (TTP) Announces Submission of FDA Meeting Request Regarding Probuphine 9/4/2013  More...
PFM Medical Receives FDA Premarket Approval (PMA) for Nit-Occlud® PDA, Transcatheter Patent Ductus Arteriosus (PDA) Occlusion Device 8/22/2013  More...
HeartWare (HTWR)'s Still Chasing PMA, More Study Results on the Way 8/21/2013  More...
FDA Rejects Wright Medical Group, Inc. (WGMI)'s Bone Graft Application 8/9/2013  More...
Ocular Therapeutix, Inc. Announces FDA Panel Meeting for the ReSure® Sealant 8/6/2013  More...
Ocular Therapeutix, Inc. Wins FDA Panel Date for ReSure Sealant 8/5/2013  More...
Cardium Therapeutics, Inc. (CXM) Announces New Excellagen FDA 510(k) Submission Based on Expanded Structural and Functional Properties 8/5/2013  More...
GE Healthcare Submits the Final Module of Its Premarket Approval Application (PMA) for GE Breast Tomosynthesis Option 7/30/2013  More...
EnteroMedics (ETRMD) Announces PMA Application for VBLOC Therapy in Obesity Accepted for Review and Filing by FDA 7/26/2013  More...
CryoLife, Inc. (CRY) Receives FDA Premarket Approval (PMA) for New Sologrip Minimally Invasive TMR Laser Fiber-Optic Delivery System 7/10/2013  More...
Roche (RHHBY) Submits Filing to FDA for Cervical Cancer Primary Screening Indication for Cobas® HPV Test 7/8/2013  More...
Guided Therapeutics, Inc. Continues to Await Update From FDA on Its PMA Application for LuViva® Advanced Cervical Scan 7/3/2013  More...
EnteroMedics (ETRMD) Submits PMA App Obesity-Device Despite Mixed Trial Results 6/25/2013  More...
AngioScore, Inc. Announces PMA Supplement Approval Allowing a Summary of the AGILITY Coronary Bifurcation Trial Results in the AngioSculpt® IFU 6/12/2013  More...
EXACT Sciences Corporation (EXAS) Applies to FDA to Sell Colon Cancer Test to Public 6/10/2013  More...
China's Curative Medical to Seek CFDA Approval for ALung Technologies' Respiratory Device 5/23/2013  More...
EnteroMedics (ETRMD) Completes VBLOC Therapy Pre-PMA Meeting With FDA 5/17/2013  More...
Inx Medical Raises $700,000, Seeks FDA Approval for Device 5/9/2013  More...
FDA Grants Premarket Approval (PMA) for the SEDASYS® System For Healthy Patients Undergoing Sedation During Routine Colonoscopy and EGD Procedures 5/6/2013  More...
FDA Panel Votes in Favor of Allergan Inc. (AGN)'s Juvederm Voluma XC Facial Filler 5/3/2013  More...
Delcath Systems, Inc. (DCTH) Hit With Another FDA Setback 5/1/2013  More...
FDA Delays Approval of Titan Pharmaceuticals (TTP)'s Suboxone Implant 5/1/2013  More...
Cerus Corporation (CERS) Announces FDA Agreement on Modular Premarket Approval (PMA) Application Submission Process for INTERCEPT Platelets 4/24/2013  More...
BioFire Diagnostics, Inc Submits 510(k) Application to FDA for FilmArray® Blood Culture Identification Test 4/17/2013  More...
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  More...
FDA Panel Recommends Approval for Bausch & Lomb's Trulign Toric Eye Implant 4/9/2013  More...
Seventh Sense Biosystems Inc. Announces Initiation of Registration Trial for Painless TAP™ Blood Collection Device 4/2/2013  More...
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  More...
pSivida Corp (PSDV) Takes Another Stab at FDA Approval for Iluvien 3/27/2013  More...
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  More...
FDA Staff Does Not Recommend Approval of Abbott Laboratories (ABT) Heart Device 3/19/2013  More...
CellAegis Devices Inc. Receives Marketing Authorization From Health Canada for the AutoRIC™ Device to Provide Non-Invasive Remote Ischemic Conditioning (RIC) 3/7/2013  More...
Epigenomics AG Receives Notification of Priority Review Status and Acceptance for Filing by FDA of PMA Application for Epi proColon® 2/21/2013  More...
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  More...
Second Sight's First Bionic Eye for U.S. Market Awaits Approval From FDA 1/29/2013  More...
Alimera Sciences (ALIM)' ILUVIEN® Receives Marketing Authorization in Spain for the Treatment of Chronic Diabetic Macular Edema 1/17/2013  More...
GE Healthcare Announces Acceptance of Applications for Review of Investigational Imaging Agent [18F]Flutemetamol in the United States and Europe 1/8/2013  More...
Epigenomics AG Submits the Fourth Module and Completes Its PMA Submission to the FDA for Epi proColon® 1/7/2013  More...
Aethlon Medical (AEMD) Discloses Submission of Hepatitis C Virus (HCV) IDE to FDA 1/3/2013  More...
Venaxis, Inc. (APPY) Files for CE Approval for APPY1 in Europe 12/21/2012  More...
Cerus Corporation (CERS) Announces FDA Agreement on Modular Premarket Approval Application (PMA) Submission Process for INTERCEPT Plasma 12/13/2012  More...
EXACT Sciences Corporation (EXAS) Submits First Module of Premarket Approval Application to FDA 12/11/2012  More...
FzioMed Inc. Files Citizen Petition for Reconsideration Following FDA Rejection of Its Spinal Gel PMA 12/7/2012  More...
Given Imaging Ltd. (GIVN) Submits PillCam® COLON 2 Application to FDA for U.S. Regulatory Clearance 11/27/2012  More...
Sunshine Heart Receives Unconditional FDA Approval for C-Pulse® System's U.S. Pivotal Trial 11/21/2012  More...
Dune Medical Devices Ltd. Receives Approvable Letter From FDA for the MarginProbe® System 11/19/2012  More...
VisionCare Ophthalmic Technologies Receives Health Canada License for First-Ever Telescope Prosthesis for End-Stage Macular Degeneration 11/8/2012  More...
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  More...
Cohera Medical, Inc. Receives Approval for First Module of Its Premarket Approval Application (PMA) for TissuGlu® Surgical Adhesive 10/30/2012  More...
FDA Panel Votes to Expand PMA for Hologic, Inc. (HOLX)'s Mammography System 10/29/2012  More...
NuVasive, Inc. (NUVA) Announces PMA Approval of the PCM(R) Cervical Disc System 10/26/2012  More...
On-X Life Technologies, Inc. Submits for FDA/CE Approval of Reduced Anticoagulation Indication for On-X Aortic Heart Valve 10/22/2012  More...
Delcath Systems, Inc. (DCTH) Clears Important FDA Hurdle 10/17/2012  More...
Coaxia Inc. Wins FDA Panel Date for Cerebral Ischemia Device 10/12/2012  More...
iSonea Limited Files FDA Submission for Over-the-Counter SonoSentry™ 10/3/2012  More...
FDA Recommends Approval for Second Sight's Argus® II Retinal Prosthesis System 10/1/2012  More...
Sunshine Heart Announces Conditional Approval of IDE From the FDA for C-Pulse® Heart Assist System 10/1/2012  More...
AEterna Zentaris (AEZS) Provides Update on NDA Filing for AEZS-130 as Diagnostic Test for Adult Growth Hormone Deficiency 9/26/2012  More...
Southern California Medical Device Maker Dallen Medical Files for FDA Clearance 9/25/2012  More...
Bal Seal Engineering, Inc.: Market Growth Spurs New Hire, MEDTEC China Presence 9/20/2012  More...
MolecularMD and Ariad Pharmaceuticals, Inc. (ARIA) Announce Voluntary Withdrawal of MolecularMD's Premarket Approval Application for BCR-ABL T315I Mutation Test 9/18/2012  More...
FDA Rejects Navidea Biopharmaceuticals (NEOP)' Tracing Agent Lymphoseek 9/12/2012  More...
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  More...
Biosign Technologies Inc. Files FDA Premarket 510(k) Notification for UFIT TEN-10 "Automated Wrist Blood Pressure Monitor" 8/13/2012  More...
AspenBio Pharma, Inc. Submits Pre-IDE Information Package to FDA for AppyScore™ Appendicitis Test System 8/7/2012  More...
Philosys Anticipates FDA Approval for New Gmate® Blood Glucose Monitoring System 8/3/2012  More...
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  More...
Anaxsys Files 510(k) for respiR8™ Continuous Respiratory Rate Counter 7/25/2012  More...
Guided Therapeutics, Inc. and FDA Agree on Plan for LuViva® Advanced Cervical Scan PMA 7/25/2012  More...
BioMimetic Therapeutics, Inc. (BMTI) Submits Augment®Bone Graft PMA Amendment to FDA 7/10/2012  More...
FDA Approves Beckman Coulter, Inc. (BEC)'s New Blood Test to Improve Prostate Cancer Detection 6/26/2012  More...
FDA Rejects Repligen Corporation (RGEN)'s Imaging Agent, Shares Drop 6/22/2012  More...
Kelyniam Global Files 510k for Custom Craniofacial Implants & Closes Financings 6/20/2012  More...
Roche (RHHBY) Submits TnT-hs Assay for FDA Clearance on Cobas Immunoassay, Elecsys Analyzers 6/8/2012  More...
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  More...
Allied Healthcare Group Files for CE Mark for Heart Patch 6/6/2012  More...
FDA Panel Backs OraSure Technologies, Inc. (OSUR)'s First at Home HIV Test 5/16/2012  More...
U-Systems Receives FDA PMA Approvable Letter for Somo•v Automated Breast Ultrasound (ABUS) System 5/14/2012  More...
Guided Therapeutics, Inc. Submits Response to FDA for LuViva® Advanced Cervical Scan PMA 5/9/2012  More...
SANUWAVE, Inc. Receives Conditional Approval from the FDA on Clinical Trial Plan for dermaPACE 5/8/2012  More...
FDA Panel Backs Cameron Health's Heart Defibrillator 4/27/2012  More...
HeartWare (HTWR) Soars as FDA Panel Backs Implantable Pump 4/26/2012  More...
Diatron to Offer Advanced Hematology Analyzer in the U.S. 4/24/2012  More...
FDA Panel Scheduled to Review Edwards Lifesciences Corporation (EW) Sapien Valve for High-Risk Patients on June 13 4/9/2012  More...
Dune Medical Devices Ltd.'s Breast Cancer Device Gets a Date With the FDA 4/6/2012  More...
Cameron Health’s S-ICD® System Scheduled for FDA Panel Review on April 26, 2012 3/19/2012  More...
HeartWare Announces Date for FDA Advisory Committee Panel 2/14/2012  More...
NeurogesX, Inc. (NGSX) Sinks Some More After FDA Panel Votes Against HIV Pain Patch 2/10/2012  More...
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  More...
MindChild Medical, Inc. Files FDA Application for Fetal Heart Monitor 2/6/2012  More...
VuCOMP Receives Premarket Approval for Mammography Computer-Aided Detection System 2/3/2012  More...
Idaho Technology Inc. Seeks FDA Clearance for the Expanded FilmArray® Respiratory Panel 1/31/2012  More...
InSightec Submits Pre Market Application (PMA) for FDA Approval of ExAblate for Treatment of Painful Bone Metastases 1/24/2012  More...
Guided Therapeutics, Inc. Provides Update on PMA Application for LuViva® Advanced Cervical Scan and Timing for Filing of CE Mark 1/23/2012  More...
Uromedica, Inc. Fighting for FDA Approval 1/13/2012  More...
LipoScience, Inc. Submits FDA 510(K) for Vantera® Clinical Analyzer 1/5/2012  More...
BioMimetic Therapeutics, Inc. (BMTI) Receives Augment® Bone Graft PMA Response Letter from FDA 1/4/2012  More...
OraSure Technologies, Inc. (OSUR) Makes Final FDA Submission for Approval of Over-the-Counter Rapid HIV Test 1/3/2012  More...
GenMark Diagnostics (GNMK) Submits Respiratory Viral Panel Test for FDA 510(k) Clearance 12/22/2011  More...
SANUWAVE, Inc. Updates on FDA Review of dermaPACE Premarket Approval Application 12/22/2011  More...
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  More...
FDA Panel Votes Against CardioMEMS Device 12/9/2011  More...
Steris Corporation (STE) Still Awaiting FDA Clearance of Key Accessory to System 1E Device 11/15/2011  More...
Great Basin Corporation Submits 510(K) Application to FDA for C. Difficile Molecular Diagnostic Test 11/14/2011  More...
U-Systems' Automated Breast Ultrasound Premarket Approval Application for Breast Cancer Screening Accepted for FDA Review 11/10/2011  More...
Guided Therapeutics, Inc. Reports Update on FDA Review of LuViva(TM) Advanced Cervical Scan PMA Application 11/2/2011  More...
Guided Therapeutics, Inc. Reports Update on FDA Review of LuViva™ Advanced Cervical Scan PMA Application 11/2/2011  More...
FDA Advisers Reject Medtronic, Inc. (MDT) Heart Device 10/28/2011  More...
Boston Biomedical Associates Helps AtriCure, Inc. (ATRC) 's Synergy Ablation System Win a Recommendation from FDA Expert Advisors 10/28/2011  More...
FDA Advisors: AtriCure, Inc. (ATRC) Device Effective for afib; Stock Rises +1.82 (18.20%) @ 11:21AM EDT 10/27/2011  More...
Contura's Aquamid Wrinkle Filler Hits Regulatory Bump 10/21/2011  More...
Neoprobe Corporation (NEOP) Receives FDA Acceptance of Lymphoseek(R) (tilmanocept) New Drug Application 10/20/2011  More...
Chembio Diagnostics, Inc. (CEMI.OB) Files PMA Module II With FDA for DPP(R) HIV Test 10/3/2011  More...
ALR Technologies Inc. Filed Response to Most Recent FDA Questions on 510(k) for the ALRT Health-e-Connect (HeC) System 9/26/2011  More...
Mela Sciences (MELA) Receives Approvable Letter From FDA for MelaFind(R) 9/26/2011  More...
Cook Medical Gets Panel Date for Zilver 9/13/2011  More...
ZYTO Corp. Announces Approval of Its 510(k) Filing With the ZYTO Corp. 9/8/2011  More...
Repligen Corporation (RGEN) Seeks Approval for Imaging Product While Pursuing Rare-Disease Drugs and Manufacturing Platform 9/2/2011  More...
Kalypto Medical Seeks 510(k) Ban for Smith & Nephew Inc.'s Wound Device 8/22/2011  More...
Nephros Inc. (NEP) Files 510(k) Application for Hemodiafiltration System 8/12/2011  More...
Ortho-Tag Seeks FDA Approval for System that IDs Surgical Implants 8/1/2011  More...
Roche (RHHBY) Submits Acute Hepatitis B Test to FDA for Premarket Approval 7/26/2011  More...
Bio-Rad Laboratories, Inc. (BIO) Receives FDA Premarket Application Approval for Its Fourth-Generation HIV Assay 7/25/2011  More...
SANUWAVE Health Submits Final Module of PMA Application for FDA Approval of dermaPACE to Treat Diabetic Foot Ulcers 7/6/2011  More...
Chembio Diagnostics, Inc. (CEMI.OB) Initiates Pre-IDE Studies for Home Use of Sure Check(R) Rapid HIV Test 6/27/2011  More...
D. Medical Industries Ltd. (DMED) Submits CE Mark Approval Application for "Spring Zone" Durable Insulin Pump 6/24/2011  More...
FDA Advisory Panel to Review Edwards Lifesciences Corporation (EW) SAPIEN Valve on July 20 6/7/2011  More...
FDA Approves Review of Dune Medical Devices Ltd.'s Medical Breast Cancer Device 5/19/2011  More...
FDA Formally Accepts Dune Medical Devices Ltd.'s MarginProbe(TM) System Pre-Market Approval (PMA) Application and Grants Expedited Review Status 5/16/2011  More...
Hansen Medical Submits 510(k) Application With U.S. FDA for Vascular Robotic System and Catheter 4/11/2011  More...
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  More...
DNA Genotek Submits Filing for 510(k) Clearance 3/15/2011  More...
Mela Sciences Release: Company Files MelaFind(R) PMA Amendment With U.S. FDA 3/2/2011  More...
Dynatronics Corporation (DYNT) Named Contract Supplier to Amerinet, Inc.'s 50,000 Members 1/27/2011  More...
Celera Corporation (CRA) Files U.S. Regulatory Application for KIF6 Genotyping Assay 1/3/2011  More...
HeartWare Files PMA Application for FDA Approval of the HeartWare(R) Ventricular Assist System for a Bridge-to-Transplant Indication 12/28/2010  More...
SANUWAVE, Inc. Health Submits to FDA First Module of PMA Application for dermaPACE for the Treatment of Diabetic Foot Ulcers 12/10/2010  More...
Neoprobe Corporation (NEOP) Granted Pre-IND Meeting with FDA to Review RIGS Technology 12/9/2010  More...
FDA Accepts Guided Therapeutics, Inc.' Non-Invasive Cervical Cancer Scanner PMA Application for Review 12/2/2010  More...
Imaging Diagnostic Systems (IMDS) Announces Filing of 510(k) Submission to FDA 11/23/2010  More...
Tenaxis Medical, Inc. Announces 'Fileable' Status of PMA 10/26/2010  More...
Neoprobe Corporation (NEOP) Lymphoseek Pre-NDA Meeting 10/7/2010  More...
Guided Therapeutics, Inc. Files Premarket Approval Application for Non-Invasive Cervical Cancer Scanner with FDA 9/27/2010  More...
Cook Medical Files Pre-Market Approval Application for FDA Approval of A Balloon Expandable Stent for Renal Artery Disease 9/24/2010  More...
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  More...
BioMimetic Therapeutics, Inc. (BMTI) PMA Remains on Track 9/8/2010  More...
Arrayit Corporation Announces Premarket Approval (PMA) Submission Strategy for OvaDx(R) 8/23/2010  More...
INVO Bioscience Commences Registration Process for INVOCell Fertility Device in China 8/10/2010  More...
Bio-Rad Laboratories, Inc. (BIO) Submits Premarket Approval Application to the FDA for Its Fourth-Generation HIV Assay 7/26/2010  More...
Candela (CLZR) Achieves Approval to Market Its Vbeam(R) Lasers in Japan 7/19/2010  More...
NeuroPace, Inc. Submits PMA Application for FDA Approval of Novel Investigational Device for Epilepsy 7/8/2010  More...
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  More...
BioMimetic Therapeutics, Inc. (BMTI) Receives Filing Letter from FDA for Augment(TM) Bone Graft PMA 6/29/2010  More...
BioMimetic Therapeutics, Inc. (BMTI) Receives Filing Letter from FDA for Augment(TM) Bone Graft PMA 6/28/2010  More...
University of Arkansas for Medical Sciences Study: Device Uses Fingerprints To Track Children's Data 6/25/2010  More...





 

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