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Medical Dev. & Diag. - Pre-Market Approvals (PMA)
Mevion Medical Systems Submits 510(K) Premarket Notification For The MEVION S250i Proton Therapy System With HYPERSCAN Technology 9/18/2017
TransEnterix (TRXC) Reports Progress On Senhance FDA Submission 9/18/2017
Global Health Solutions Announces Filing Of FDA 510(K) Application For Antimicrobial Saturated Petrolatum Gauze 9/7/2017
Establishment Labs Submits Investigational Device Exemption (IDE) Filing For Prospective Clinical Trial Of Motiva Implants 8/8/2017
EDAP TMS (EDAP) Announces Filing Of 510(K) Application For Ablatherm-Fusion Device 7/31/2017
Mithra Pharmaceuticals Submits Myring For European Marketing Approval 7/17/2017
IsoRay (ISR) Receives FDA Response to 510(k) Application For GammaTile 7/6/2017
SciBase AB Receives US Approval For Nevisense 6/29/2017
Nexstim Files 510(K) Submission For Its NBT System For The Treatment Of Depression With U.S. FDA 6/27/2017
TSO3 (TOS) Expands Duodenoscope Regulatory Filing Strategy 6/14/2017
Bruker Corporation Acquires Emerging Light Sheet Microscopy Company Luxendo 5/8/2017
Global Health Solutions Announces Filing Of 510(K) Application For FDA Clearance Of Non-Steroidal Eczema Formula 5/3/2017
Biotricity Files For Its Second And Final FDA 510(K) To Bring Bioflux Solution To Market 4/12/2017
Genedrive HCV Assay Submitted For CE IVD Certification 3/27/2017
Advanced Sterilization Products Submits 510(K) Application For 30-Minute STERRAD Velocity Biological Indicator System 3/16/2017
Statement From Health Canada On The Publication Of A White Paper On Public Release Of Clinical Information In Drug Submissions And Medical Device Applications 3/10/2017
Ortho Clinical Diagnostics Submits VITROS Immunodiagnostic Products HIV Combo Assay To FDA For Review; Applies To Expand Use Of Specialty Hepatitis Assays 2/23/2017
FDA Grants PMA Approval For Hologic (HOLX)'s Aptima Hepatitis C Quant Dx Assay 2/16/2017
World’s First Medically-Accurate Health Monitoring System Integrated In A Smartphone Now Readied For Leman Micro Devices Approval By FDA 2/16/2017
Owlet Release: Medical Device Company Submits For FDA Clearance On Owlet Smart Sock 1/24/2017
Mithra Pharmaceuticals Release: Company Plans To Submit Myring For US And EU Approval In Q2 2017 1/24/2017
QIAGEN N.V. (QGEN) Submits QuantiFERON-TB Gold Plus for U.S. Regulatory Approval 1/9/2017
Hologic (HOLX) Release: FDA Grants PMA Approval For Hologic's Aptima HIV-1 Quant Assay 1/3/2017
Intrinsic Therapeutics Announces The Filing Of PMA Application For Its Barricaid Anular Closure Device For Lumbar Discectomy Patients 12/21/2016
FDA Denies Milestone Scientific (MS)’s Compu-Flo 510(K) Application 12/16/2016
Becton, Dickinson and Company (BDX) MAX Vaginal Panel Receives FDA Market Authorization To Detect Most Common Causes Of Vaginal Infections 10/31/2016
Becton, Dickinson and Company (BDX) Submits Pre-Market Approval Application to FDA for BD Onclarity HPV Test 9/6/2016
bioMerieux Submits 510(K) Application To The bioMerieux For BacT/ALERT VIRTUO Next Generation Automated Blood Culture System 8/3/2016
Intersect ENT Announces FDA Submission Of NOVA Bioabsorbable Steroid Releasing Implant For Patients With Chronic Sinus Disease 8/1/2016
Asuragen, Inc.'s QuantideX qPCR BCR-ABL IS Kit Receives FDA Premarket Clearance For Monitoring Minimal Residual Disease In Chronic Myeloid Leukemia 7/25/2016
FDA Advisory Says Yes to DexCom (DXCM)'s G5 Mobile CGM System 7/22/2016
Allergan (AGN) Files Application To FDA For Approval Of Oculeve Intranasal Tear Neurostimulator 7/18/2016
Varian Medical Systems (VAR) Receives FDA Registration For Claymount Optica Collimators 7/18/2016
Cartiva Announces FDA Premarket Approval For Cartiva Synthetic Cartilage Implant 7/5/2016
Integrity Applications Incorporated Release: GlucoTrack Maker Submitted Pre-Submission Supplement To US FDA 6/1/2016
Essential Medical Announces CE Mark Submission For MANTA Large Bore Vascular Closure Device 5/3/2016
Accuray Inc. (ARAY) Submits 510(K) Premarket Notification To FDA For Its Radixact Treatment Delivery System 4/27/2016
Hansen Medical (HNSN) Announces Filing Of 510K For Expanded Neurological Indication For Magellan Product Line 4/27/2016
Boston Biomedical Partners With CardioFocus In Premarket Approval Of Heartlight System 4/14/2016
Fortimedix B.V. Surgical Announces 510(K) Submission For Innovative FMX314 Surgical Platform 3/25/2016
Roche (RHHBY) Submits Filing To FDA For cobas Procalcitonin (PCT) Assay To Help Clinicians Assess Response Of Septic Patients To Treatment 3/23/2016
Dune Medical Devices Ltd. Release: MarginProbe Modification Receives FDA Pre-Market Approval 3/23/2016
Roche (RHHBY) Submits Filing To FDA For HbA1c Testing Solution To Help Meet Increasing Demand For Hba1c Testing Of People With Diabetes 3/3/2016
Angel Medical Systems Announces FDA Advisory Committee Meeting For Review Of The Angelmed Guardian System 2/8/2016
VolitionRX Receives International ISO Certification For Quality Management System Of Its Nuq Blood Tests 1/28/2016
Epigenomics AG Receives FDA Notification About Status Of Pending Approval Decision For Epi proColon 1/8/2016
NovoCure Submits PMA Partial Amendment Application To Japanese Pharmaceuticals And Medical Devices Agency For Treatment Of Newly Diagnosed Glioblastoma Patients 1/8/2016
NovoCure Files Premarket Approval Supplement Application With FDA For Second Generation Optune System 1/6/2016
Roche (RHHBY) submits Anti-Mullerian Hormone Assay For FDA Approval 12/17/2015
SciBase AB Submits Application For Pre-Market Approval To FDA 12/9/2015
Guided Therapeutics And FDA Review Team Agree On Path Forward For Luviva® Advanced Cervical Scan PMA Application 12/2/2015
FUJIFILM Submits Second PMA Module For Aspire Cristalle Digital Breast Tomosynthesis Option 11/25/2015
FDA Grants Guided Therapeutics’ Request For New Meeting Date To Plan Path Forward For Luviva® Advanced Cervical Scan PMA Application 11/5/2015
Tryton Medical Files Pre-Market Approval Application With U.S. FDA For Tryton Side Branch Stent 11/2/2015
InSightec Submits Pre-Market Application (PMA) For FDA Approval Of Exablate Neuro For Treatment Of Essential Tremor 10/22/2015
Transcend Medical, Inc. Submits Final Module Of FDA Premarket Approval Application For The CyPass Glaucoma Micro-Stent 10/22/2015
ADM Tronics Unlimited (ADMT) Announces FDA 510(K) Application Filed For Angiodroid CO2 Injector For Angiography 10/14/2015
FDA Grants QIDP Designation To LMB For Mino-Lok, A Novel Antibiotic Lock Therapy In Development To Treat Catheter Related Blood Stream Infection (CRBSI) 10/13/2015
Nemaura Medical Announces Filing Of Application For FDA Pre-Submission Program For Sugarbeat System 10/13/2015
Great Basin Scientific Submits 510(K) Application To The FDA For Shiga Toxin Direct Test 10/8/2015
Compass Biomedical Announces FDA Drug Master File Acceptance For PLUS Human Platelet Lysate 10/6/2015
Intersect ENT Announces FDA Submission To Seek Expanded Indication Of PROPEL Mini Steroid Releasing Implant To Treat Patients With Frontal Sinus Disease 9/29/2015
ReVision Optics, Inc. Files Final Module Of FDA Premarket Approval Application For Raindrop Near Vision Inlay For The Correction Of Presbyopia 9/28/2015
CardioFocus Inc.' HeartLight PMA For The Treatment Of Atrial Fibrillation Filed And Accepted For Review By The FDA 9/15/2015
Guided Therapeutics and U.S. FDA Agree on Meeting Date to Plan Path Forward for LuViva Advanced Cervical Scan PMA 9/15/2015
AirXpanders Submits FDA 510(k) Filing for AeroForm 9/1/2015
Luminex (LMNX) Submits 510(K) Application For The NxTAG Respiratory Pathogen Panel 8/26/2015
Guided Therapeutics Advances LuViva PMA Application With FDA 8/18/2015
Bay Area's Avinger Announces Early 510(k) Filing for Pantheris 8/12/2015
BioElectronics Corporation Files FDA Premarket Notification For ActiPatch Therapy 8/10/2015
Roche (RHHBY) Submits Filing To FDA For Companion Diagnostic For Non-Small Cell Lung Cancer Drug Therapy 7/30/2015
Bio-Rad (BIO) Announces U.S. FDA Pre-Market Approval For The BioPlex 2200 HIV Ag-Ab Assay, A Novel Next Generation HIV Diagnostic Test 7/29/2015
Aspire Bariatrics Submits To FDA A PMA Application Of AspireAssist, A Minimally-Invasive Alternative To Weight Loss Surgery 7/28/2015
FDA Wants More Information for EDAP TMS S.A. (EDAP)'s Direct De Novo 510(k) Petition 7/21/2015
Luminex (LMNX) Submits FDA 510(K) Submissions For ARIES System And ARIES HSV 1&2 Assay 7/15/2015
MCRA Assists VertiFlex With Obtaining FDA PMA Approval For The Superion Interspinous Spacer System 6/25/2015
CeraPedics, Inc. Announces FDA Advisory Committee Panel Is Not Required For I-FACTOR PMA Approval 6/16/2015
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