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Medical Dev. & Diag. - Regulatory
FDA Sets New Regulations Affecting Entire AED Market 10/1/2015
Biomerica (BMRA) Working With FDA On Submission For Its IBS Product 9/30/2015
iNeedMD Receives CFDA Registration In China 9/30/2015
Avant Diagnostics Commences Ovadx Ovarian Cancer Test Calibration In Preparation For FDA Submission 9/24/2015
Tactio Health Group Release: TactioRPM Now Registered At The FDA As A Class 1 Medical Device Data System 9/24/2015
Roche (RHHBY) Receives FDA CLIA Waiver For Flu A/B Test For Use On Its Cobas Liat PCR System 9/22/2015
Xhale Inc. Submits Biomarker Qualification Package To FDA For Medication Adherence Monitoring Tool 9/22/2015
FDA Expands Warnings About Contaminated Medical Scopes 9/18/2015
ANSYS, Inc. (ANSS) Certified For The Latest Generation Chip Technology 9/17/2015
IntriCon Corporation (IIN) Secures National Health Service Product Approval 9/17/2015
Bracket Announces EXACT e-Diary Certification On Tablet And Smartphone 9/15/2015
Gecko Biomedical Achieves Significant Milestone With ISO 13485:2003 Certification 9/14/2015
Graftys Announces The Extension Of Its CE Mark For Its Calcium Phosphate Cements To Now Include GRAFTYS HBS And GRAFTYS Quickset For The Indication Of Subchondral Bone Marrow Lesions Around The Knee Joint (BML) 9/14/2015
First Patient Enrolled In CeloNova’s e-COBRA Clinical Registry 9/14/2015
RedHill Biopharma Ltd. (RDHL) And IntelGenx Corp. Announce RIZAPORT (RHB-103) Marketing Authorization Application Is Approvable Under The European Decentralized Procedure 9/10/2015
BioCision, LLC Announces FDA Master File Acceptance For Thawstar Automated Cell Thawing Instrument 9/9/2015
EndoGastric Solutions, Inc. Announces AMA Assignment Of CPT Code And Short Form Descriptor 9/9/2015
Cynvenio Receives Accreditation From College of American Pathologists 9/8/2015
Medigus (MDGS.TA) Announces American Medical Association's Publication Of New Category I CPT Code 9/8/2015
Cancer Genetics (CGIX) Increases Access To Proprietary Diagnostics Tests As Part Of New Agreement With Blue Cross Blue Shield Of Illinois 9/8/2015
Bioo Scientific Corporation Receives USDA Approval For Using Its ELISA To Screen Meat For Ractopamine Residues 9/2/2015
Bestronics Achieves ISO 13485 Certification 9/1/2015
Great Basin Scientific Submits 510(K) Application To The FDA For Staph ID/R Blood Culture 8/31/2015
EDAP TMS S.A. (EDAP) Provides Formal Response To FDA Addressing All Concerns Raised In July 2015 Ablatherm HIFU Letter 8/25/2015
CombiMatrix (CBMX)'s Combisnp Array For Prenatal Diagnosis Test Granted Approval From New York City Department of Health and Mental Hygiene 8/18/2015
Bay Area's Avinger Announces Early 510(k) Filing for Pantheris 8/12/2015
Rosetta Genomics Ltd. (ROSG) Receives Conditional Approval From New York State For Lung Biomarker 8/6/2015
Cardiac MRI Post-Processing, Precision Image Analysis Inc. Receives ISO 9001:2008 Certification 7/30/2015
Agendia BV Release: NCCN Breast Cancer Guidelines Acknowledge MammaPrint’s Ability to Predict Prognosis 7/28/2015
HTG Molecular Diagnostics Achieves ISO 13485:2003 Recertification 7/24/2015
Sigma-Aldrich Corporation (SIAL) Meets Evolving Quality and Regulatory Needs with ISO 13485 Expansion, Provides Diagnostic Customers with Reliable Critical Raw Materials 7/23/2015
FDA Wants More Information for EDAP TMS S.A. (EDAP)'s Direct De Novo 510(k) Petition 7/21/2015
Konica Minolta Medical Imaging U.S.A, Inc. (KPI1.BE) AeroDR Achieves Compliance With FIPS 140-2 Security Standard For DoD AND VA Facilities 7/21/2015
NanoString (NSTG) Release: NCCN Clinical Practice Guidelines For Breast Cancer Acknowledge Prosigna/PAM50 As Clinically Validated For Prediction Of Prognosis 7/17/2015
MolecularMD Receives New York State Approval For Next Generation Sequencing Test To Support Clinical Trial Enrollment 7/17/2015
Roka Bioscience, Inc. (ROKA) Receives AOAC Certification For The Atlas Listeria Environmental Detection Assay 7/15/2015
Vericel (ASTM) Announces Plan To Submit HDE Supplement To The FDA To Revise The Labeled Indications For Use And Add Pediatric Labeling For Epicel 7/14/2015
ASPiRA Labs Receives New York State Permit 7/13/2015
Neogen Corporation (NEOG)'s ANSR For Listeria monocytogenes Receives AOAC Approval 7/10/2015
Medtech Giants Johnson & Johnson (JNJ), Medtronic (MDT), St. Jude Medical (STJ) Beef Up Product Guarantees to Woo Hospitals 7/9/2015
Amedica Corporation Provides Update On FDA Questions And Femoral Head Testing Protocol Feedback 7/8/2015
Mauna Kea Technologies Receives Regulatory Approval For The AQ-Flex 19 Miniprobe In Japan 7/6/2015
Acorn Regulatory Streamlines Approval Process For U.S. Drug-Device Manufacturers 7/1/2015
ImmunID Receives Accreditation From College of American Pathologists 6/30/2015
EMPERRA's Bluetooth-Enabled ESYSTA Smart Insulin Pen And The ESYSTA Smartphone App In The Last Stages Of The CE Approval Process 6/24/2015
Thermo Fisher Scientific (TMO) Release: OIE Approves Registration Of BOVIGAM TB Kit In Diagnostics Manual, Boosting Global Effort To Manage Bovine Tuberculosis 6/24/2015
Anika Therapeutics (ANIK) Files Investigational Device Exemption To Initiate Phase III Study To Expand Indication Of MONOVISC To Treat Pain Caused By Osteoarthritis Of The Hip 6/23/2015
IsoRay, Inc. (ISR)'s Quality Management System Granted Continued Certification To Highest ISO Standard For Medical Device Manufacturers 6/18/2015
Adherium Receives ISO 13485 Certification 6/16/2015
Cohera Medical, Inc. Receives Expedited Access Pathway Designation From FDA For SylysSurgical Sealant 6/9/2015
HeartWare (HTWR) Issues Voluntary Device Correction 6/9/2015
Benchmark Electronics' Nashua, New Hampshire Facility Awarded ISO 13485:2003 Certification For Medical Devices 6/5/2015
Guided Therapeutics Awarded Multiple Tenders For Luviva Advanced Cervical Scan Systems From Governments In Bangladesh 6/4/2015
TransEnterix Submits 510(K) Application To FDA For Surgibot System 6/1/2015
China Probes Official Who Supervised Medical Device Sector 5/29/2015
Advanced Bionics Corporation Announces TÜV Approval Of Naída CI Q90 EAS 5/29/2015
TowerJazz Certifies ANSYS, Inc. (ANSS) Solutions For Its 180nm Family Of Process Design Kits And Reference Flow 5/28/2015
Thoratec Corporation (THOR) Receives Conditional FDA Approval For The Shield II U.S. Clinical Trial For HeartMate PHP 5/26/2015
MagForce AG: Magforce USA, Inc. Files Investigational Device Exemption For Nanotherm Therapy To Treat Intermediate Risk Prostate Cancer 5/21/2015
Resolution Bioscience Receives CLIA Certification For Its Diagnostic Laboratory And Launches CLIA-Certified Liquid Biopsy For Lung Cancer 5/20/2015
FDA Needs More Data Before Approving Guided Therapeutics’ LuViva Advanced Cervical Scan 5/20/2015
Cleveland HeartLab Receives Internationally Recognized Quality Designation ISO 13485 And Achieves CE Mark For New Universal MPO Assay; Opening New Global Markets For Valuable And Proprietary MPO Testing 5/19/2015
Magnesium Elektron Achieves ISO 13485:2012 Certification For Its SynerMag Technology Centre 5/18/2015
UMC Certifies ANSYS, Inc. (ANSS) Power Integrity And Electromigration Solutions For 28 And 40nm Technologies 5/12/2015
AcelRx (ACRX) Crashes as the FDA Rejects Request for Meeting on Pain Drug Device 5/6/2015
Signal Genetics LLC (SGNL)' Laboratory Receives Accreditation From College of American Pathologists 4/30/2015
CryoLife (CRY) Announces Resolution of FDA Warning Letter 4/28/2015
Bacterin International, Inc. Receives Coverage From Medicare Administrative Contractor (MAC) For Hmatrix 4/28/2015
Critical Path Institute Secures Regulatory Support For Parkinson’s And Alzheimer’s Disease Biomarkers 4/28/2015
FDA Orders Medtronic (MDT) to Stop Manufacturing Pain Drug Pump 4/28/2015
Agilent Technologies Inc. (A) Announces Resolution To U.S. FDA Warning Letter For Dako Denmark 4/22/2015
Cancer Genetics, Inc. (CGIX) Receives New York State Licensure For FHACT Cervical Cancer Test 4/16/2015
Alliqua Biomedical (ALQA) Receives Coverage From Medicare Administrative Contractor (MAC) For Biovance 4/16/2015
Henry Schein, Inc. (HSIC) World Headquarters Building Achieves LEED Silver Certification 4/13/2015
New FDA Program Will Expedite Approval Of "Breakthrough" Medical Devices for Sickest Patients 4/10/2015
TSMC Certifies ANSYS, Inc. (ANSS) Power Integrity And Electromigration Solutions For 10nm FinFET Early Design Start 4/6/2015
Vascular Solutions (VASC), CEO Get Ready to Take on FDA Conspiracy Charges 3/31/2015
Cepheid (CPHD) Receives Emergency Use Authorization From FDA For Xpert Ebola Diagnostic Test 3/25/2015
Simplify Cervical Artificial Disc Receives IDE Approval 3/18/2015
NanoString (NSTG)' Prosigna Breast Cancer Assay Included In German Breast Cancer Treatment Guidelines 3/18/2015
SCIENION US, Inc. Receives ISO 13485 Certification 3/18/2015
Accelerate Diagnostics (AXDX) Achieves ISO 13485 Certification And Initial Installations Of Accelerate ID/AST System 3/17/2015
Mauna Kea Technologies Receives Additional CPT Reimbursement Code In The U.S. Supporting Key Application Of Endomicroscopy With Cellvizio In The Biliary Tract 3/17/2015
Ontrion Medical Device Batteries Receive Safety CB Test Certificate IEC 62133 3/13/2015
Enzo Biochem (ENZ) Announces New York State Approval Of First Flowscript Assay For Improved Detection Of Cervical Cancer Progression 3/13/2015
FDA Now Requires Proof That Reusable Medical Devices Can Be Reliably Cleaned 3/13/2015
Olympus Corporation Fought With the FDA for Tighter Rules for Devices That Spread Superbugs 3/11/2015
Medigus (MDGS.TA) Announces American Medical Association Publication Of Category I CPT Code For Esophagogastric Fundoplasty Trans-Orifice Procedures 3/11/2015
FDA Wants AcelRx (ACRX) to Run Another Trial on Zalviso Drug-Device Combo 3/10/2015
EndoGastric Solutions, Inc. Announces American Medical Association’s Publication Of New Category I CPT Code For Esophagogastric Fundoplasty Trans-Orifice Procedure 3/10/2015
Intrinsic Imaging Awarded Interventional Medical Device Trial For Prevention Of Pulmonary Emboli 3/4/2015
Calgary Scientific Release: ResolutionMD Receives Class II Certification For Web And Mobile Diagnosis In Japan 3/3/2015
C.R. Bard Release: CMS Approves Pass-Through Payment For Lutonix DCB For Outpatient Use 2/20/2015
Maquet Cardiovascular LLC Agrees to Hire Outside Inspectors in Deal With the FDA 2/20/2015
Oncore Manufacturing Receives ISO13485 Certification And IPC J-STD-001 QML/ Qualified Manufacturer List At Its Suzhou, China Facility 2/19/2015
Five Apple (AAPL) Execs Meet With Mexican Regulators Ahead of Smartwatch Debut 2/18/2015
ALR Technologies Inc. Seeks FDA Approval For Insulin Dose Adjustment Feature For Better Diabetes Management 2/17/2015
Avedro, Inc. Announces Date For FDA Advisory Committee Meeting 2/17/2015
Vermillion Receives ISO 13485 Certification For Company's Quality Management System 2/13/2015
True Diagnostics, Inc. Completes FDA Pre-Submission For TrueDX(TM)-TSH Test 2/13/2015
Amedica Corporation Submits 510(K) Application To FDA For Composite Spinal Interbody Spacers With Porous Silicon Nitride Center 2/12/2015
Vital Connect Receives Medical Device Ninsho Certification To Market Healthpatch MD In Japan 2/12/2015
Zimmer (ZMH) Provides Update On The European Commission (EC) Review Process Relating To The Pending Merger With Biomet Inc. 2/10/2015
Nanotherapeutics Receives Expanded 510(K) Marketing Clearance From The FDA For Nanofuse DBM 2/10/2015
Advanced Prenatal Therapeutics Receives Notice Of Allowance For Preeclampsia Device 2/9/2015
Akers Biosciences, Inc.' Management System Certified To ISO 13485 (2003) 2/9/2015
FDA Denies Venaxis, Inc. (APPY)'s Appendicitis Test 510(k) Submission 1/29/2015
MagForce AG And Magforce USA, Inc. Announce FDA Pre-IDE Meeting On Magforce's Nanotherm™ Prostate Cancer Therapy Pre-Submission 1/27/2015
Apple (AAPL) Watch Is a Wellness Tool, Not a Medical Device: FDA 1/22/2015
FDA Officially Clears Integra LifeSciences Holdings Corporation (IART)'s Plant Problems 1/21/2015
FDA Warns Philips Respironics on Malfunction Reporting 1/20/2015
GE Healthcare And NextGen Healthcare First To Achieve EHNAC's Practice Management System Accreditation 1/20/2015
After Public Shaming in 2013, 23andMe Aims to End FDA Standoff 1/13/2015
FDA Waiver Of Alere Inc. (ALR)'s Flu Test Poses Threat to Cepheid (CPHD) 1/13/2015
QIAGEN Inc. (QGEN) Announces First-Ever Regulatory Registration Of A Lung Cancer Companion Diagnostic Based On Liquid Biopsies 1/12/2015
Isotope Technologies Garching Received Manufacturing Authorization For Ga-68 Generator 1/12/2015
FDA Lifts Import Ban on Hospira, Inc.'s Infusion Pumps 1/9/2015
Chipscreen Biosciences Announces CFDA Approval Of Chidamide (Epidaza) For PTCLs In China 1/9/2015
ANSYS, Inc. (ANSS) SCADE Receives ISO 26262 Qualification 1/8/2015
Biocept, Inc. (BIOC)'s Proprietary Oncology Diagnostics To Be Offered On America's Choice Provider Network 1/7/2015
1} Receives Positive Coverage Decision For Allomap® From Two Additional Medicare Administrative Carrier Jurisdictions 1/7/2015
Medytox Diagnostics Awarded License To Begin Lab Testing In New York State 1/7/2015
FDA Grants Faustus Forschungs Cie. Translational Cancer Resea Humanitarian Use Device (HUD) Designation 1/6/2015
Empowered Products Receives European CE Certification For PINK® And Gun Oil® Brands Of Personal Lubricants As Class 1 Medical Devices 1/6/2015
Cancer Genetics, Inc. (CGIX) Receives Approval To Provide Oncology Testing For Patients In California 1/5/2015
Cesca Therapeutics Receives Feedback From the FDA on Its Pivotal Investigational Device Exemption ("IDE") Application for Treating Critical Limb Ischemia ("CLI") 1/2/2015
FDA Seeks Additional Info on Cesca Therapeutics's Pivotal IDE Application for Treating CLI 1/2/2015
CytoSorbents, Inc. Submits IDE Application To FDA For U.S. Cytosorb® Cardiac Surgery Trial 12/30/2014
Carestream Health, Inc. Is First Company To Receive U.S. Navy Certification To Implement Medical Image Management Systems 12/22/2014
IRadimed Corporation Resumes Domestic Distribution Of Infusion Pumps 12/22/2014
FDA Mulls Using Drones To Conduct Site Inspections 12/19/2014
Trinity Biotech (TRIB) Announces CLIA Waiver Of Rapid Syphilis Test 12/17/2014
Cohera Medical, Inc. Receives Priority Review Status Designation From FDA For Sylys Surgical Sealant 12/17/2014
Amway Release: eSpring Brand Is First To Be Certified To All 15 New NSF/ANSI 401 Emerging Contaminants 12/15/2014
VertiFlex Announces FDA Advisory Panel Meeting For The Superion® Interspinous Spacer System 12/12/2014
Response Genetics, Inc. Secures New York State Department Of Health Approval For The Company's Responsedx® Testing Services 12/11/2014
FDA Postpones Panel Meeting For VertiFlex's Superion Spine Device 12/10/2014
Intrinsic Therapeutics Completes Major Regulatory And Clinical Milestones 12/9/2014
Cohera Medical, Inc. Submits Investigational Device Exemption To FDA For Clinical Trial Of Its Sylys Surgical Sealant 12/9/2014
U.S. FDA Grants CLIA Waiver For Alere Determine HIV-1/2 Ag/Ab Combo Test 12/9/2014
Eternity Healthcare Release: FDA Approves A Safer Way To Administer Vaccines 12/9/2014
Violations Are Isolated Incidents: AngioDynamics (ANGO) CEO Says 12/8/2014
WuXi PharmaTech Co., Ltd. Subsidiary Submits Application To The National Equities Exchange And Quotations In China To List On The New Third Board 12/4/2014
Mainstay Medical (MSTY.PA) Achieves Quality System Certification 12/3/2014
Ekso Bionics (EKSO) To Submit 510(k) Notification In December 12/3/2014
AngioDynamics (ANGO) Cited For Safety Violations 12/2/2014
Novocure Announces FDA Approval Of An IDE Supplement Allowing All Control Patients In Its Phase 3 Trial In Newly Diagnosed GBM To Cross Over To Receive Tumor Treating Fields 12/2/2014
Medtronic, Inc. (MDT) Selling Bonds For Covidien (COV) Acquisition 12/1/2014
Federal Trade Commission Gives Medtronic, Inc. (MDT), Covidien (COV) Merger The Green Light 12/1/2014
Nanomix, Inc. Receives ISO 13485:2003 Certification 12/1/2014
SpineGuard Successfully Passes ANVISA’s Inspection, Paving The Way For Registration Of Its New Products In Brazil 12/1/2014
Vela Diagnostics Announces The Listing Of Their Next-Generation Sequencing System With The U.S. FDA As A Class II Medical Device 12/1/2014
IRadimed Corporation Files 510(K) Submission For Premarket Notification 11/25/2014
Nanomix, Inc. Receives ISO 13485:2003 Certification 11/25/2014
FDA Strengthens Warning On Tool For Fibroid Surgeries 11/24/2014
ZOLL Medical Corporation (ZOLL) Files With Japan’s Pharmaceuticals And Medical Devices Agency For New Indication For Intravascular Temperature Management Technology 11/21/2014
Sanmina India Design Center Awarded Latest ISO 13485 Design Certifications For Medical Devices 11/20/2014
Great Basin Scientific, Inc. Submits 510(K) Application To FDA For Group B Strep Assay 11/19/2014
Terumo BCT And Banco de Sangre de Servicios Mutuos Unite In A Treatment Use Program Developed To Help Improve Blood Supply Safety Using An Investigational Device 11/19/2014
EPA Conclusion On Sterilizer Could Disrupt Medical Device Supply, Companies Say 11/18/2014
Vela Diagnostics Announces The Listing Of their Next-Generation Sequencing System With The U.S. FDA As A Class II Medical Device 11/12/2014
Medtronic, Inc. (MDT) Offers EU Concessions In $43 Billion Covidien (COV) Deal 11/11/2014
Rhinomed (ASX:RNO) Turbine Achieves CE Mark Registration 11/11/2014
NeuroSigma, Inc. Receives Notice Of Allowance From The Mexican Institute Of Industrial Property Covering Subcutaneous Trigeminal Nerve Stimulation (sTNS) 11/3/2014
Alliqua Biomedical (ALQA)'s Biovance® Assigned Level II HCPCS Q Code For Product Reimbursement 11/3/2014
Abiomed (ABMD) Surges On FDA Deal For Impella Indication 10/31/2014
Chembio Diagnostics, Inc. (CEMI.OB)'s DPP® HIV 1/2 Assay Receives CLIA Waiver From FDA 10/30/2014
InspireMD Ltd. Investigational Device Exemption (IDE) Amendment Approved By The FDA 10/30/2014
AngioDynamics (ANGO) Release: NanoKnife System Receives OPS Procedure Classification Codes In Germany 10/28/2014
Myriad Genetics, Inc. (MYGN) Announces Inclusion Of Prolaris® Test In NCCN Guidelines 10/27/2014
Biodesix, Inc. Announces Inclusion Of Veristrat In Updated NCCN Guidelines 10/24/2014
Ivera Medical Corporation Successfully Completes FDA Inspection 10/21/2014
bioMerieux SA Working To Get FDA Approval For Ebola Screening Test 10/21/2014
Cerus Corporation (CERS) Submits Compassionate Use IDE Supplement For INTERCEPT Blood System Treatment Of Ebola Convalescent Plasma 10/20/2014
Hunter Technology Licensed By CA Food And Drug Branch To Manufacture Finished Medical Devices For Oems; EMS Adheres To Stringent Quality Standards On Path To FDA Registration 10/16/2014
Otoharmonics Corporation Release: Levo Tinnitus System Receives Health Canada License As A Class 2 Medical Device 10/16/2014
FDA Panel Cautiously Recommends Boston Scientific Corporation (BSX)’s Heart Device 10/10/2014
RTI Surgical (RTIX) Receives Letter From FDA On Map3® Cellular Allogeneic Bone Graft 10/9/2014
Materialise's Heartprint® Now Listed As A Class 1 Medical Device 10/9/2014
FDA Doubtful On New Watchman Data From Boston Scientific Corporation (BSX) 10/8/2014
Can Chocolate Bars With Silver Nanoparticles Cure Ebola? FDA Commissioner Riffs On Fraud 10/8/2014
FDA Green Lights Integra LifeSciences Corporation (IART) Puerto Rico Plant 10/8/2014
FDA Accepts IDE Submission By Cerus Corporation (CERS) Making The INTERCEPT Blood System Available To Address Chikungunya And Dengue Blood Safety Risks 10/7/2014
Proposed Merger Of Zimmer Holdings, Inc. And Biomet Inc. To Enter Second Phase Review By European Commission 10/3/2014
FDA Issues New Guidelines For Medical Devices' Cybersecurity 10/2/2014
Alere Inc. (ALR) Release: Entamoeba histolytica Rapid Test Receives CE Mark 10/2/2014
Helius Medical Technologies Announces Health Canada Approval To Start Investigational Testing For The Pons™ Device 10/2/2014
Avedro, Inc. Announces Resubmission Of New Drug Application To FDA For Corneal Cross-Linking 9/30/2014
AltheaDx Receives Approval From New York State For IDgenetix Tests 9/29/2014
Medina Medical Announces CE Mark For Its Embolization Coil 9/25/2014
VertiFlex Scores FDA Panel Date For Superion Interspinous Spacer 9/24/2014
World Health Organization Issues Prequalification Of Becton, Dickinson and Company (BDX) FACSPresto™ Near-Patient CD4 Counter System For HIV/AIDS Monitoring 9/24/2014
Sophia Genetics Receives CE-IVD Mark For Genetic Testing Of Familial Mediterranean Fever And Hypercholeteromia 9/24/2014
Atossa Genetics, Inc. (ATOS) Provides Regulatory And Commercial Update On Its ForeCYTE Breast Aspirator And Its FullCYTE Breast Aspirator 9/24/2014
T2 Biosystems (TTOO) Receives FDA Authorization To Market T2Candida And T2Dx For The Detection Of Sepsis-Causing Pathogens 9/23/2014
GHX Successfully Submits Product Data To The FDA Production Global UDI Database (GUDID) Ahead Of Deadline 9/23/2014
World Health Organization Issues Prequalification Of Becton, Dickinson and Company (BDX) FACSPresto™ Near-Patient CD4 Counter System For HIV/AIDS Monitoring 9/23/2014
Thermo Fisher Scientific (TMO) Announces Listing Of The Ion PGM Dx System With The U.S. FDA As Class II Medical Device 9/18/2014
Neuromod Secures ISO Certification Ahead Of Multisensory Tinnitus Treatment Launch 9/18/2014
IRadimed Corporation Announces Conference Call To Discuss The Status Of The Recent FDA Warning Letter 9/16/2014