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Medical Dev. & Diag. - Pre-Market Approvals (PMA)
FDA Needs More Data Before Approving Guided Therapeutics’ LuViva Advanced Cervical Scan 5/20/2015
FDA Grants Premarket Approval For Silk Road Medical's ENROUTE Transcarotid Stent System 5/19/2015
FDA Grants Priority Review Status For NovoCure Ltd.’s PMA Supplement Application Of Optune In Newly Diagnosed Glioblastoma 5/11/2015
Transcend Medical, Inc. Announces Intent To File Premarket Approval Application With FDA For The CyPass Glaucoma Micro-Stent 5/5/2015
Cartiva Announces Submission Of Final Module Of PMA Application For Cartiva SCI 5/4/2015
BRH Medical, Ltd., Announces Filing Of A Pre-Market Submission With The FDA For The BRH-A2 Tissue Management System 4/27/2015
Aethlon Medical (AEMD) Announces Ebola Humanitarian Use Device Submission To The FDA 4/9/2015
BG Medicine (BGMD) Submits 510(K) To FDA For Additional Indication For The BGM Galectin-3(R) Test 3/31/2015
MolecularMD Receives ISO Certification For Design, Development And Production Of Molecular Diagnostic Products 3/30/2015
LabStyle Innovations Submits Data To U.S. FDA From Successfully Concluded 368 Patient Clinical Study Of Dario Diabetes Management Solution For 510(K) Marketing Clearance 3/24/2015
EDAP TMS S.A. (EDAP) Announces Plans To Pursue Direct De Novo 510(K) Petition In Lieu Of PMA For Its Ablatherm HIFU 3/9/2015
ZOLL Medical Corporation (ZOLL) ResQCPR System Receives Premarket Approval From The FDA 3/9/2015
VertiFlex Announces FDA Advisory Panel Support For The Superion Interspinous Spacer 2/23/2015
Anika Therapeutics (ANIK) Announces Regulatory Submissions With U.S. FDA And European Regulatory Authorities For Cingal 2/12/2015
Integra LifeSciences Holdings Corporation (IART) Announces Submission Of A Premarket Approval Supplement Application For The Treatment Of Diabetic Foot Ulcers 2/4/2015
Guided Therapeutics, Inc. Provides An Update On FDA Review Time For Luviva® Advanced Cervical Scan 2/3/2015
FDA Grants Pre-Market Approval For Medtronic, Inc. (MDT) Melody® Transcatheter Pulmonary Valve 2/3/2015
FDA Denies Venaxis, Inc. (APPY)'s Appendicitis Test 510(k) Submission 1/29/2015
Ventana Medical Systems, Inc. (VMSI) Seeks FDA Premarket Approval For ALK IHC Companion Diagnostic To Benefit Lung Cancer Patients 1/21/2015
Flowonix Announces FDA PMA(S) Approval Of Prometra II 1/19/2015
Cohera Medical, Inc. Receives PMA Approvable Letter From U.S. FDA For TissuGlu® Surgical Adhesive 1/6/2015
United Therapeutics Corporation (UTHR) Announces Submission Of Pre-Market Approval Application For Implantable Drug Infusion System To Deliver Remodulin 12/24/2014
Advanced Medical Isotopes Corporation Files A "De Novo" Submission For Y-90 Radiogel(TM) Device 12/23/2014
Allium Medical Submitted Application To The FDA For Clearance Of The Gardia WIRION Filter System In The US 12/22/2014
Bio-Rad Laboratories, Inc. (BIO) Receives Premarket Application Approval For Its Geenius HIV 1/2 Supplemental Assay 11/19/2014
EDAP TMS S.A. (EDAP) Receives FDA Guidance On PMA for Ablatherm-HIFU 11/6/2014
Paragonix Technologies Inc., Announces Filing Of Two 510(K) Pre-Market Notifications With FDA 11/3/2014
Flowonix Submits PMA Supplements for Prometra® Implantable Pump System 9/15/2014
Cerus Corporation (CERS) Submits IDE Supplement To Make INTERCEPT Platelets Available Pre-Approval In U.S. Areas At Risk From Outbreaks Of Chikungunya And Dengue 9/10/2014
CeraPedics, Inc. Files Premarket Approval Application With FDA For i-FACTOR™ Peptide Enhanced Bone Graft 9/4/2014
BioTime (BTX) Receives FDA Premarket Notification Clearance For Premvia™ 510(k) 8/12/2014
EDAP TMS S.A. (EDAP) Did Not Provide Enough Evidence That Prostate Cancer Device Is Safe: FDA 8/1/2014
Cerus Corporation (CERS) Submits Final Module In Premarket Approval (PMA) Application Process For INTERCEPT Platelets 7/17/2014
diaDexus Announces FDA Acceptance For Review Of 510(K) Submission For PLAC Test For Lp-PLA2 Activity 7/17/2014
Paragonix Technologies Inc., Announces Filing Of A 510(K) Pre-Market Notification With FDA For The Paragonix Sherpa Perfusion™ Cardiac Transport System 7/14/2014
Siemens (SI) Files PMA For Digital Breast Tomosynthesis 6/27/2014
Cohera Medical, Inc.'s TissuGlu® Surgical Adhesive Advances To FDA Advisory Panel Meeting 6/10/2014
Cartiva Submits First Module Of PMA Application For Cartiva SCI 6/10/2014
AcuFocus, Inc. Gets Mixed FDA Panel Review For Presbyopia Device 6/9/2014
FDA Issues Response Letter For Epigenomics AG's Colorectal Cancer Screening Blood Test Epi Procolon® Requesting Further Data Pre-Approval 6/2/2014
Minomic To Register Mistat ™ELISA Prostate Cancer Test For CE Mark Approval 5/27/2014
Amsel Medical Announces Filing Of A 510(K) Pre-Marketing Notification With The FDA For The Amsel Occluder Device 5/20/2014
Cohera Medical, Inc. Sealant Seeks CE Mark Approval 5/15/2014
Guided Therapeutics, Inc. To File Amended PMA Application For Cervical Scanner 5/14/2014
SonaCare Medical Progresses To FDA Panel Review For Its Sonablate® 450 Prostate Ablation System 5/9/2014
Guided Therapeutics, Inc. Receives May 8th Meeting Date From FDA To Discuss Luviva® Advanced Cervical Scan PMA Application 4/10/2014
Myriad Genetics, Inc. (MYGN) Submits Premarket Approval To FDA For Bracanalysis® 4/8/2014
Stereotaxis, Inc. (STXS) Submits 510(K) Application To FDA For Vdrive™ With V-Loop™ System 4/1/2014
VertiFlex Announces Submission Of Final PMA Module To The FDA, For The Superion® Interspinous Spacer System 4/1/2014
FDA Panel Backs EXACT Sciences Corporation (EXAS)'s Cologuard 3/28/2014
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
Merck & Co., Inc. (MRK), Endocyte, Inc. (ECYT) Cancer Products Get Thumbs Up From EU Committee CHMP 3/21/2014
EDAP TMS S.A. (EDAP) Completes FDA Q&A Session For Its Ablatherm-HIFU Pre-Market Approval Application 3/20/2014
FDA Asks For More Data On Avedro, Inc.'s Eye Therapy System 3/19/2014
FDA Panel Recommends Clearance For Immucor (BLUD) Blood-Typing Chip 3/19/2014
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
FDA Advisory Committee: Roche (RHHBY)'s DNA Test Can Replace Pap Smear 3/13/2014
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
AngioDynamics (ANGO) Win FDA Nod For DuraMax Dialysis Catheter 3/7/2014
AngioDynamics (ANGO) Updates U.S. Tip Location Strategy 3/7/2014
Atossa Genetics, Inc. (ATOS) Announces FDA Response to 510(k) Submission for ForeCYTE Breast Aspirator 3/4/2014
FDA Wants More Info From Atossa Genetics, Inc. (ATOS) For Forecyte Breast Aspirator 3/4/2014
BioFire Diagnostics, Inc Submits 510(k) Application To FDA For FilmArray® Gastrointestinal Panel 2/19/2014
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
eNeura Therapeutics Files 510(K) With The FDA For Springtms® Migraine Treatment 1/27/2014
Greatbatch, Inc. (GB) Requests CE Mark For Spinal Cord Stim 1/21/2014
Echo Therapeutics (ECTE) Submits CE Mark Technical File For Its Symphony® CGM System 1/13/2014
Encision, Inc. (ECIA) Files 510(K) With FDA For AEM ® Simplification Product 1/8/2014
Sapheon, Inc. Submits Second Module Of PMA Application For VenaSeal® Sapheon Closure System; Raises $10M In Bridge Note Financing 1/7/2014
LabStyle Innovations Files 510(K) In The U.S. For FDA Clearance Of The Dario™ Blood Glucose Monitoring System 1/7/2014
Actavis (ACT) Denies FDA' Contraceptive Patch, Seeks More Data 12/30/2013
Alimera Sciences (ALIM), pSivida Corp (PSDV) Rocket On FDA Labeling Talks For Eye Drug 12/20/2013
Corgenix Medical Corporation (CONX) Announces Filing Of 510(k) Premarket Notification For FDA Clearance Of TxBCardio™ Assay 12/16/2013
Boston Scientific Corporation (BSX)'s Anti-Stroke Device Wins FDA Panel's Blessing 12/12/2013
Boston Scientific Corporation (BSX) May Face A Tough FDA Panel 12/11/2013
Cerus Corporation (CERS) Submits Final Module In The Premarket Approval (PMA) Application Process For INTERCEPT Plasma 12/4/2013
Epigenomics AG Announces FDA Advisory Committee Meeting To Review Epi proColon® 11/27/2013
C.R. Bard Submits Final PMA Module To The FDA For The Lutonix Drug-Coated Balloon 11/26/2013
Cohera Medical, Inc. Completes Fourth And Final Module In The Premarket Approval (PMA) Application For TissuGlu® Surgical Adhesive 11/19/2013
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
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
Boston Scientific Corporation (BSX)'s Anti-Stroke Watchman Heart Implant Lands A Date With The FDA 11/12/2013
FzioMed Inc. Wins Independent Review of Oxiplex Gel 11/5/2013
Advanced Medical Isotopes Corporation Files 510(k) Pre-Market Notification for FDA Clearance of Yttrium-90 RadioGel™ Brachytherapy Product 11/4/2013
MiMedx Lands a Date With the FDA 10/18/2013
FDA Advisory Panel Recommends Expanded Indication for Medtronic, Inc. (MDT) CRT Devices in Patients With AV Block and Reduced Heart Function 10/9/2013
Cerus Corporation (CERS) Submits the First of Three Modules in the Premarket Approval (PMA) Application Process for INTERCEPT Platelets 10/1/2013
Sapheon, Inc. Submits First Module of PMA Application for VenaSeal® Sapheon Closure System 9/20/2013
FDA Ophthalmic Devices Panel Favorably Votes for the Ocular Therapeutix, Inc.'s Resure® Sealant 9/20/2013
FDA Has More Questions About Guided Therapeutics, Inc.'s LuViva 9/10/2013
Titan Pharmaceuticals (TTP) Announces Submission of FDA Meeting Request Regarding Probuphine 9/4/2013
PFM Medical Receives FDA Premarket Approval (PMA) for Nit-Occlud® PDA, Transcatheter Patent Ductus Arteriosus (PDA) Occlusion Device 8/22/2013
HeartWare (HTWR)'s Still Chasing PMA, More Study Results on the Way 8/21/2013
FDA Rejects Wright Medical Group, Inc. (WGMI)'s Bone Graft Application 8/9/2013
Ocular Therapeutix, Inc. Announces FDA Panel Meeting for the ReSure® Sealant 8/6/2013
Ocular Therapeutix, Inc. Wins FDA Panel Date for ReSure Sealant 8/5/2013
Cardium Therapeutics, Inc. (CXM) Announces New Excellagen FDA 510(k) Submission Based on Expanded Structural and Functional Properties 8/5/2013
GE Healthcare Submits the Final Module of Its Premarket Approval Application (PMA) for GE Breast Tomosynthesis Option 7/30/2013
EnteroMedics (ETRMD) Announces PMA Application for VBLOC Therapy in Obesity Accepted for Review and Filing by FDA 7/26/2013
CryoLife, Inc. (CRY) Receives FDA Premarket Approval (PMA) for New Sologrip Minimally Invasive TMR Laser Fiber-Optic Delivery System 7/10/2013
Roche (RHHBY) Submits Filing to FDA for Cervical Cancer Primary Screening Indication for Cobas® HPV Test 7/8/2013
Guided Therapeutics, Inc. Continues to Await Update From FDA on Its PMA Application for LuViva® Advanced Cervical Scan 7/3/2013
EnteroMedics (ETRMD) Submits PMA App Obesity-Device Despite Mixed Trial Results 6/25/2013
AngioScore, Inc. Announces PMA Supplement Approval Allowing a Summary of the AGILITY Coronary Bifurcation Trial Results in the AngioSculpt® IFU 6/12/2013
EXACT Sciences Corporation (EXAS) Applies to FDA to Sell Colon Cancer Test to Public 6/10/2013
China's Curative Medical to Seek CFDA Approval for ALung Technologies' Respiratory Device 5/23/2013
EnteroMedics (ETRMD) Completes VBLOC Therapy Pre-PMA Meeting With FDA 5/17/2013
Inx Medical Raises $700,000, Seeks FDA Approval for Device 5/9/2013
FDA Grants Premarket Approval (PMA) for the SEDASYS® System For Healthy Patients Undergoing Sedation During Routine Colonoscopy and EGD Procedures 5/6/2013
FDA Panel Votes in Favor of Allergan Inc. (AGN)'s Juvederm Voluma XC Facial Filler 5/3/2013
Delcath Systems, Inc. (DCTH) Hit With Another FDA Setback 5/1/2013
FDA Delays Approval of Titan Pharmaceuticals (TTP)'s Suboxone Implant 5/1/2013
Cerus Corporation (CERS) Announces FDA Agreement on Modular Premarket Approval (PMA) Application Submission Process for INTERCEPT Platelets 4/24/2013
BioFire Diagnostics, Inc Submits 510(k) Application to FDA for FilmArray® Blood Culture Identification Test 4/17/2013
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
FDA Panel Recommends Approval for Bausch & Lomb's Trulign Toric Eye Implant 4/9/2013
Seventh Sense Biosystems Inc. Announces Initiation of Registration Trial for Painless TAP™ Blood Collection Device 4/2/2013
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
pSivida Corp (PSDV) Takes Another Stab at FDA Approval for Iluvien 3/27/2013
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
FDA Staff Does Not Recommend Approval of Abbott Laboratories (ABT) Heart Device 3/19/2013
CellAegis Devices Inc. Receives Marketing Authorization From Health Canada for the AutoRIC™ Device to Provide Non-Invasive Remote Ischemic Conditioning (RIC) 3/7/2013
Epigenomics AG Receives Notification of Priority Review Status and Acceptance for Filing by FDA of PMA Application for Epi proColon® 2/21/2013
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
Second Sight's First Bionic Eye for U.S. Market Awaits Approval From FDA 1/29/2013
Alimera Sciences (ALIM)' ILUVIEN® Receives Marketing Authorization in Spain for the Treatment of Chronic Diabetic Macular Edema 1/17/2013
GE Healthcare Announces Acceptance of Applications for Review of Investigational Imaging Agent [18F]Flutemetamol in the United States and Europe 1/8/2013
Epigenomics AG Submits the Fourth Module and Completes Its PMA Submission to the FDA for Epi proColon® 1/7/2013
Aethlon Medical (AEMD) Discloses Submission of Hepatitis C Virus (HCV) IDE to FDA 1/3/2013
Venaxis, Inc. (APPY) Files for CE Approval for APPY1 in Europe 12/21/2012
Cerus Corporation (CERS) Announces FDA Agreement on Modular Premarket Approval Application (PMA) Submission Process for INTERCEPT Plasma 12/13/2012
EXACT Sciences Corporation (EXAS) Submits First Module of Premarket Approval Application to FDA 12/11/2012
FzioMed Inc. Files Citizen Petition for Reconsideration Following FDA Rejection of Its Spinal Gel PMA 12/7/2012
Given Imaging Ltd. (GIVN) Submits PillCam® COLON 2 Application to FDA for U.S. Regulatory Clearance 11/27/2012
Sunshine Heart Receives Unconditional FDA Approval for C-Pulse® System's U.S. Pivotal Trial 11/21/2012
Dune Medical Devices Ltd. Receives Approvable Letter From FDA for the MarginProbe® System 11/19/2012
VisionCare Ophthalmic Technologies Receives Health Canada License for First-Ever Telescope Prosthesis for End-Stage Macular Degeneration 11/8/2012
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
Cohera Medical, Inc. Receives Approval for First Module of Its Premarket Approval Application (PMA) for TissuGlu® Surgical Adhesive 10/30/2012
FDA Panel Votes to Expand PMA for Hologic, Inc. (HOLX)'s Mammography System 10/29/2012
NuVasive, Inc. (NUVA) Announces PMA Approval of the PCM(R) Cervical Disc System 10/26/2012
On-X Life Technologies, Inc. Submits for FDA/CE Approval of Reduced Anticoagulation Indication for On-X Aortic Heart Valve 10/22/2012
Delcath Systems, Inc. (DCTH) Clears Important FDA Hurdle 10/17/2012
Coaxia Inc. Wins FDA Panel Date for Cerebral Ischemia Device 10/12/2012
iSonea Limited Files FDA Submission for Over-the-Counter SonoSentry™ 10/3/2012
FDA Recommends Approval for Second Sight's Argus® II Retinal Prosthesis System 10/1/2012
Sunshine Heart Announces Conditional Approval of IDE From the FDA for C-Pulse® Heart Assist System 10/1/2012
AEterna Zentaris (AEZS) Provides Update on NDA Filing for AEZS-130 as Diagnostic Test for Adult Growth Hormone Deficiency 9/26/2012
Southern California Medical Device Maker Dallen Medical Files for FDA Clearance 9/25/2012
Bal Seal Engineering, Inc.: Market Growth Spurs New Hire, MEDTEC China Presence 9/20/2012
MolecularMD and Ariad Pharmaceuticals, Inc. (ARIA) Announce Voluntary Withdrawal of MolecularMD's Premarket Approval Application for BCR-ABL T315I Mutation Test 9/18/2012
FDA Rejects Navidea Biopharmaceuticals (NEOP)' Tracing Agent Lymphoseek 9/12/2012
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
Biosign Technologies Inc. Files FDA Premarket 510(k) Notification for UFIT TEN-10 "Automated Wrist Blood Pressure Monitor" 8/13/2012
AspenBio Pharma, Inc. Submits Pre-IDE Information Package to FDA for AppyScore™ Appendicitis Test System 8/7/2012
Philosys Anticipates FDA Approval for New Gmate® Blood Glucose Monitoring System 8/3/2012
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
Anaxsys Files 510(k) for respiR8™ Continuous Respiratory Rate Counter 7/25/2012
Guided Therapeutics, Inc. and FDA Agree on Plan for LuViva® Advanced Cervical Scan PMA 7/25/2012
BioMimetic Therapeutics, Inc. (BMTI) Submits Augment®Bone Graft PMA Amendment to FDA 7/10/2012
FDA Approves Beckman Coulter, Inc. (BEC)'s New Blood Test to Improve Prostate Cancer Detection 6/26/2012
FDA Rejects Repligen Corporation (RGEN)'s Imaging Agent, Shares Drop 6/22/2012
Kelyniam Global Files 510k for Custom Craniofacial Implants & Closes Financings 6/20/2012
Roche (RHHBY) Submits TnT-hs Assay for FDA Clearance on Cobas Immunoassay, Elecsys Analyzers 6/8/2012
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
Allied Healthcare Group Files for CE Mark for Heart Patch 6/6/2012
FDA Panel Backs OraSure Technologies, Inc. (OSUR)'s First at Home HIV Test 5/16/2012
U-Systems Receives FDA PMA Approvable Letter for Somo•v Automated Breast Ultrasound (ABUS) System 5/14/2012
Guided Therapeutics, Inc. Submits Response to FDA for LuViva® Advanced Cervical Scan PMA 5/9/2012
SANUWAVE, Inc. Receives Conditional Approval from the FDA on Clinical Trial Plan for dermaPACE 5/8/2012
FDA Panel Backs Cameron Health's Heart Defibrillator 4/27/2012
HeartWare (HTWR) Soars as FDA Panel Backs Implantable Pump 4/26/2012
Diatron to Offer Advanced Hematology Analyzer in the U.S. 4/24/2012
FDA Panel Scheduled to Review Edwards Lifesciences Corporation (EW) Sapien Valve for High-Risk Patients on June 13 4/9/2012
Dune Medical Devices Ltd.'s Breast Cancer Device Gets a Date With the FDA 4/6/2012
Cameron Health’s S-ICD® System Scheduled for FDA Panel Review on April 26, 2012 3/19/2012
HeartWare Announces Date for FDA Advisory Committee Panel 2/14/2012
NeurogesX, Inc. (NGSX) Sinks Some More After FDA Panel Votes Against HIV Pain Patch 2/10/2012
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
MindChild Medical, Inc. Files FDA Application for Fetal Heart Monitor 2/6/2012
VuCOMP Receives Premarket Approval for Mammography Computer-Aided Detection System 2/3/2012
Idaho Technology Inc. Seeks FDA Clearance for the Expanded FilmArray® Respiratory Panel 1/31/2012
InSightec Submits Pre Market Application (PMA) for FDA Approval of ExAblate for Treatment of Painful Bone Metastases 1/24/2012
Guided Therapeutics, Inc. Provides Update on PMA Application for LuViva® Advanced Cervical Scan and Timing for Filing of CE Mark 1/23/2012
Uromedica, Inc. Fighting for FDA Approval 1/13/2012
LipoScience, Inc. Submits FDA 510(K) for Vantera® Clinical Analyzer 1/5/2012
BioMimetic Therapeutics, Inc. (BMTI) Receives Augment® Bone Graft PMA Response Letter from FDA 1/4/2012
OraSure Technologies, Inc. (OSUR) Makes Final FDA Submission for Approval of Over-the-Counter Rapid HIV Test 1/3/2012
GenMark Diagnostics (GNMK) Submits Respiratory Viral Panel Test for FDA 510(k) Clearance 12/22/2011
SANUWAVE, Inc. Updates on FDA Review of dermaPACE Premarket Approval Application 12/22/2011
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
FDA Panel Votes Against CardioMEMS Device 12/9/2011
Steris Corporation (STE) Still Awaiting FDA Clearance of Key Accessory to System 1E Device 11/15/2011
Great Basin Corporation Submits 510(K) Application to FDA for C. Difficile Molecular Diagnostic Test 11/14/2011
U-Systems' Automated Breast Ultrasound Premarket Approval Application for Breast Cancer Screening Accepted for FDA Review 11/10/2011
Guided Therapeutics, Inc. Reports Update on FDA Review of LuViva(TM) Advanced Cervical Scan PMA Application 11/2/2011
Guided Therapeutics, Inc. Reports Update on FDA Review of LuViva™ Advanced Cervical Scan PMA Application 11/2/2011
FDA Advisers Reject Medtronic, Inc. (MDT) Heart Device 10/28/2011
Boston Biomedical Associates Helps AtriCure, Inc. (ATRC) 's Synergy Ablation System Win a Recommendation from FDA Expert Advisors 10/28/2011
FDA Advisors: AtriCure, Inc. (ATRC) Device Effective for afib; Stock Rises +1.82 (18.20%) @ 11:21AM EDT 10/27/2011