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Medical Dev. & Diag. - Regulatory
NeoChord Again Awarded NUB Status 1 In Germany 2/10/2016
Bluestar Silicones Achieves ISO 8 And ISO 7 Clean Room Certification; Promotes Long-Term Implant Offering At MD&M West 2/9/2016
Admera Health Receives CLIA Approval For Its Breakthrough Liquid Biopsy Testing Platform 2/9/2016
Angel Medical Systems Announces FDA Advisory Committee Meeting For Review Of The Angelmed Guardian System 2/8/2016
Cartiva Announces Tentative Date Of FDA Advisory Panel Review Of Cartiva SCI 2/8/2016
HeartStitch Passes Critical Regulatory Audit in Kazakhstan 2/5/2016
SMTC’s Dongguan, China Facility Awarded ISO 13485 Certification For Medical Devices 2/2/2016
Intersect ENT Announces NUB Status 1 Designation For PROPEL Sinus Implant In Germany 1/29/2016
Veracyte (VCYT) Receives Regulatory Authorization To Offer Percepta Bronchial Genomic Classifier For Patients In New York State 1/28/2016
BioLineRx Ltd. Receives Confirmation Of Medical Device Classification In Europe For Celiac Treatment 1/25/2016
Zecotek Photonics Inc. Granted U.S. Notice Of Allowance For Enhanced LFS Crystal Array Manufacturing 1/15/2016
BioAmber Inc. Sarnia Certified To ISO 9001, ISO 14001, OHSAS 18001 And FSSC 22000 1/14/2016
New Senate Report Says FDA Fails to Make Sure Medical Devices are Safe 1/14/2016
Intouch Solutions Certified As Level Four Veeva Systems, Inc. Multichannel Content Partner 1/13/2016
Olympus (OCPNF) Releases Statement In Response To US Senate HELP Committee Report 1/13/2016
Claritas Genomics Awarded International Organization For Standardization (ISO) Accreditation For Molecular Diagnostic Testing From The American Association For Laboratory Accreditation (A2LA) 1/7/2016
MiMedx Receives Certificate From FDA Allowing The Export Of MiMedx Allografts 1/6/2016
Easton Pharmaceuticals (OP: EAPH) Provides Regulatory Filing Update For Its EvaPro (VS-Sense) Women's Diagnostic Product And Provides Updates On The Marketing And Sales Of Currently Approved Products For Most Latin American Markets 1/6/2016
Novation Announces Product Categories For Period 1 National Group Buys Program 1/4/2016
Materialise Receives FDA NSE Letter for X-Ray 510(k) Submission 12/22/2015
CytoSorbents, Inc. Issues EAP Update 12/22/2015
SunPharm (SUNP) Slumps After U.S. FDA Warning for Halol Plant 12/21/2015
AMP Responds To FDA Report On Oversight Of Laboratory Developed Testing Procedures 12/16/2015
Clontech Laboratories, Inc. Earns ISO 13485:2003 Certification 12/14/2015
CombiMatrix (CBMX)'s Array For Pre-Implantation Genetic Screening Granted Conditional Approval From New York State Department Of Health 12/10/2015
Spectranetics (SPNC) Announces FDA Submission Of Bridge Occlusion Balloon For Lead Extraction Procedures 12/9/2015
Vericel (ASTM) Submits HDE Supplement To The FDA To Revise The Labeled Indications For Use And Add Pediatric Labeling For Epicel 12/8/2015
Diagnomics And Maverix Biomics Achieve CLIA Validation For Clinical Diagnostic Pre-Natal Testing 12/8/2015
Cesca Therapeutics Receives Approval For Medicare Coverage 12/2/2015
Avinger Announces Filing Of 510(K) Application For Enhanced Version Of Pantheris 12/2/2015
Toshiba America Medical Systems’s MR Portfolio Is First To Meet Network Security Guidelines Of The U.S. Department Of Defense 12/2/2015
Blue Earth Diagnostics And Siemens (SI)’ PETNET Solutions Announce FDA Acceptance Of NDA Filing For Fluciclovine 12/2/2015
MetaStat Receives CLIA Certification From The Centers for Medicare & Medicaid Services 11/30/2015
Beckman Coulter Life Sciences Release: Aquios CL Flow Cytometer Accepted By WHO Prequalification Of In Vitro Diagnostics Programme 11/30/2015
SkylineDx Receives CE-IVD Mark For MMprofiler -- Its Innovative Gene Signature-Based Test For Multiple Myeloma 11/25/2015
Boston Scientific (BSX)'s Watchman May Catch a Break 11/24/2015
ADM Tronics (ADMT) Withdraws FDA App for Angiodroid CO2 Injector for Angiography 11/23/2015
Advanced Bionics Corporation Receives TÜV Approval for the Naída CI Q Series Of Sound Processors 11/20/2015
Meridian Bioscience (VIVO) Receives FDA Clearance For New Molecular Whooping Cough Test Claims 11/19/2015
Endologix Release: Leading Physicians To Initiate ASCEND Registry For Nellix EVAS System 11/18/2015
Enzo Biochem (ENZ) Announces New York State Approval Of Its First Assay Based On Ampiprobetm Platform Aimed At Providing Affordable Molecular Diagnostics In Light Of Reimbursement Pressure 11/17/2015
Advanced Medical Isotopes Corporation Reports Progress Towards Seeking FDA Clearance For The Y-90 Radiogel Device 11/17/2015
Stock Slides as Boston Scientific (BSX)'s Watchman Hit by Restrictive CMS Coverage Decision 11/12/2015
Opko Health (OPK) 4Kscore Test Receives Category I CPT Code Approval 11/12/2015
Amedica Corporation Submits 24-Month Clinical Data To FDA For Clearance Of Composite Interbody Spinal Device 11/11/2015
NeuroMetrix (NURO)’ Quell Wearable Pain Relief Device Receives American Podiatric Medical Association (APMA) Seal Of Approval 11/11/2015
Alere (ALR)'s SD BIOLINE HIV/Syphilis Duo Is First Dual Test To Receive WHO Prequalification 11/9/2015
PTS Diagnostics ' Patent Enforcement Against Jant Pharmacal Gains Momentum 11/6/2015
FDA Draft Guidance May Have Caught MiMedx Off-Guard 11/4/2015
ALung Receives Expedited Access Pathway Designation From FDA For Hemolung Respiratory Assist System 11/4/2015
Nuo Therapeutics Responds To Favorable CMS Hospital Outpatient Payment Final Ruling For Aurix System 11/2/2015
FDA Reports From Lab Visits Highlight Problems at Theranos 10/29/2015
EDP Biotech Achieves ISO 13485 Certification 10/28/2015
Cynosure (CYNO) Receives Health Canada Authorization To Market MonaLisa Touch For Genitourinary Syndrome Of Menopause 10/28/2015
TearScience, Inc. Announces New Pricing Strategy For Core LipiFlow Technology Used For Treatment Of Dry Eye From Meibomian Gland Disease (MGD) 10/28/2015
Nephros Inc. (NEP) Announces FDA 510(k) Submission Of S100 Ultrafilter 10/27/2015
Amsel Medical Announces Filing Of 2nd 510(K) Pre-Marketing Notification With The US Food And Drug Administration For The Amsel Occluder Device 10/27/2015
SHINE Medical Technologies Achieves Major Milestone On Path To Construction Permit Approval 10/26/2015
Cartiva Announces GMP Certification By Brazil's ANVISA 10/26/2015
TSO3 Allowed Expanded Claims For Revolutionary STERIZONE VP4 Sterilizer 10/26/2015
Theranos Continues to Battle Wall Street Journal Critics, Says FDA Made Unannounced Inspections 10/23/2015
Tryton Medical Nears FDA Submission for Stent 10/23/2015
Would Washington’s FDA Fix Cure Patients Or The Drug Industry? 10/21/2015
Gaumard Scientific's Latest UNI Operating System Is Compliant with Newly Released 2015 AHA CPR/ECC Guidelines 10/19/2015
EDAP TMS S.A. (EDAP) Direct De Novo For Ablatherm HIFU Replaced By 510(K) 10/16/2015
Kapa Biosystems Earns ISO 13485:2003 Certification 10/15/2015
Alere (ALR) Receives U.S. HHS Approval To Electronically Process Drug Tests For Department Of Transportation-Regulated Employees 10/15/2015
Gensignia Receives CLIA Certification Of Its San Diego Laboratory 10/13/2015
Promega Corporation Powerplex Fusion 6C System Receives Approval By The FBI 10/13/2015
Nemaura Medical Announces Filing Of Application For FDA Pre-Submission Program For Sugarbeat System 10/13/2015
TearLab (TEAR) Release: Medical Necessity Of Tear Osmolarity Testing In The Diagnosis And Management Of Dry Eye Disease Confirmed In Recently Published Medicare Local Coverage Determination 10/9/2015
Avant Diagnostics Receives FDAIRB Approval for OvaDx Ovarian Cancer Validation Test Specimens 10/7/2015
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