Healthcare Sales & Marketing Network News: in vitro diagnostic

Searching News Database: in vitro diagnostic

HSMN NewsFeed - 13 Jan 2025
Roche receives FDA clearance for new, highly-sensitive test to aid clinicians in diagnosing B-cell lymphoma
Diagnostics Oncology FDA

HSMN NewsFeed - 24 Oct 2024
Pillar Biosciences Receives CPT(R) Code for FDA Approved oncoReveal(TM) CDx Pan-Cancer Solid tumor IVD Kit
Diagnostics Oncology Reimbursement

HSMN NewsFeed - 9 Jul 2024
Beckman Coulter Introduces New Integrated Chemistry and Immunoassay Analyzer
Devices Diagnostics Product Launch

HSMN NewsFeed - 10 Nov 2023
EU Approval of AAV5 DetectCDx(TM) Provides Access to Companion Diagnostic for Hemophilia A Gene Therapy
Diagnostics Regulatory

HSMN NewsFeed - 25 Jul 2023
Beckman Coulter Receives FDA Clearance for DxC 500 AU Chemistry Analyzer, Expanding Portfolio with Proven Six Sigma Performance
Diagnostics FDA

HSMN NewsFeed - 26 Sep 2022
BD, CerTest Biotec Announce US Commercial Launch of Monkeypox Assay
Diagnostics Product Launch

HSMN NewsFeed - 14 Jul 2022
Study shows that selection of breast cancer patients for adjuvant bisphosphonate therapy based on Inbiomotion's MAFTEST(R) reduces the risk of death in comparison with current clinical guidance
Diagnostics Oncology

HSMN NewsFeed - 25 Mar 2022
Roche announces collaboration with Bristol Myers Squibb to advance personalised healthcare through digital pathology solutions
Diagnostics

HSMN NewsFeed - 1 Feb 2022
BD Expands from Cancer Discovery and Diagnosis into Post-Treatment Monitoring with Acquisition of Cytognos from Vitro S.A.
Diagnostics Mergers & Acquisitions

HSMN NewsFeed - 15 Dec 2021
Roche Launches the First Infectious Disease Tests and Cobas Omni Utility Channel for Use on the Cobas 5800 System in Countries Accepting the CE Mark
Diagnostics Product Launch

HSMN NewsFeed - 27 Sep 2021
Ortho Clinical Diagnostics Announces Launch of New ISXM Capabilities
Diagnostics Product Launch

HSMN NewsFeed - 25 Aug 2021
BD Launches Fully Automated High-Throughput Molecular Diagnostic Platform for U.S. Laboratories
Diagnostics Product Launch

HSMN NewsFeed - 21 Jul 2021
PathogenDx Receives CE-IVD Mark for Its Microarray-Based DetectX-Rv Test for COVID-19
Diagnostics Regulatory

HSMN NewsFeed - 13 Apr 2021
Ortho's VITROS(R) SARS-CoV-2 Antigen Test for High-Volume COVID-19 Testing Receives CE Mark; Allows for More Convenient Sample Collection and Expanded Viral Transport Media
Diagnostics Regulatory

HSMN NewsFeed - 9 Mar 2021
Roche receives FDA approval for VENTANA ALK (D5F3) CDx Assay to identify lung cancer patients eligible for targeted treatment with LORBRENA (lorlatinib)
Diagnostics Oncology FDA

HSMN NewsFeed - 4 Mar 2021
Luminex Receives FDA Emergency Use Authorization and CE Mark for Expanded NxTAG(R) Respiratory Panel Test Including SARS-CoV-2
Diagnostics FDA Regulatory

HSMN NewsFeed - 22 Feb 2021
BD Announces Collaboration for At-Home Rapid Test for COVID-19
Diagnostics

HSMN NewsFeed - 12 Feb 2021
BD Announces Emergency Use Authorization, CE Mark for Combination Molecular Diagnostic to Detect SARS-CoV-2, Influenza A+B in Single Test
Diagnostics FDA Regulatory

HSMN NewsFeed - 29 Oct 2020
Roche receives FDA approval for the cobas EGFR Mutation Test v2 as the first companion diagnostic test for expanded EGFR TKI therapies in patients with non-small cell lung cancer
Diagnostics Oncology FDA

HSMN NewsFeed - 26 Oct 2020
Helix Receives Expanded Emergency Use Authorization for On-site Unsupervised Self-Collection and Asymptomatic Screening with the Helix(R) COVID-19 Test
Diagnostics FDA

HSMN NewsFeed - 5 Oct 2020
BD Granted FDA 510(k) Clearance for BD FACSLyric(TM) Flow Cytometer with Newly Integrated BD FACSDuet(TM) Sample Preparation System
Diagnostics FDA

HSMN NewsFeed - 30 Sep 2020
BD Announces CE Mark of Portable, Rapid Point-of-Care Antigen Test to Detect SARS-CoV-2 in 15 minutes
Diagnostics Regulatory

HSMN NewsFeed - 22 Sep 2020
MicroVention-Terumo Announces New Leadership
Devices Interventional Personnel

HSMN NewsFeed - 23 Jul 2020
FDA Clears First Blood Test for Identifying a Novel Allergic Sensitization to Red Meat
Diagnostics FDA

HSMN NewsFeed - 23 Jul 2020
Beckman Coulter's Automated Blood Banking Analyzer Receives 510(k) FDA Clearance
Diagnostics FDA

HSMN NewsFeed - 22 Jul 2020
Luminex Files for Emergency Use Authorization for Expanded NxTAG Respiratory Panel Test Including SARS-CoV-2
Diagnostics FDA

HSMN NewsFeed - 6 Jul 2020
BD Launches Portable, Rapid Point-of-Care Antigen Test to Detect SARS-CoV-2 in 15 minutes, Dramatically Expanding Access to COVID-19 Testing
Diagnostics FDA Product Launch

HSMN NewsFeed - 22 Jun 2020
Invitae and ArcherDX to create a global leader in comprehensive cancer genetics and precision oncology
Diagnostics Oncology Mergers & Acquisitions

HSMN NewsFeed - 26 May 2020
ArcherDX Announces Strategic Collaboration with AstraZeneca to Develop Personalized Cancer Monitoring (PCM) Assays for Minimal Residual Disease (MRD)
Biopharmaceuticals Diagnostics Oncology

HSMN NewsFeed - 19 May 2020
ArcherDX Receives Breakthrough Device Designation to Detect NTRK Gene Fusions
Diagnostics Oncology FDA

HSMN NewsFeed - 19 May 2020
Invivoscribe Announces FDA Approval for Distribution of the LeukoStrat CDx FLT3 Mutation Assay as an IVD Kit in the United States
Diagnostics Oncology FDA

HSMN NewsFeed - 11 May 2020
Abbott Receives FDA Emergency Use Authorization for COVID-19 Antibody Blood Test on Alinity(TM) i System
Diagnostics FDA Product Launch

HSMN NewsFeed - 24 Apr 2020
Vela Diagnostics Receives CE Mark for COVID-19 Detection Test
Diagnostics Regulatory

HSMN NewsFeed - 3 Apr 2020
BD, BioGX Announce FDA Emergency Use Authorization for New COVID-19 Diagnostic for Use in U.S.
Diagnostics FDA

HSMN NewsFeed - 2 Apr 2020
Haemonetics Acquires enicor GmbH to Expand Advanced Viscoelastic Testing Portfolio
Devices Mergers & Acquisitions

HSMN NewsFeed - 25 Mar 2020
ArcherDX Receives Approval for Archer(R)MET Companion Diagnostic for TEPMETKO(R) (Tepotinib) in Advanced Non-Small Cell Lung Cancer in Japan
Diagnostics Oncology Regulatory

HSMN NewsFeed - 17 Mar 2020
Researchers At UC San Diego Evaluating Potential "One-Hour" COVID-19 Diagnostic Test Developed By Irvine-Based Innovator Fluxergy
Diagnostics

HSMN NewsFeed - 17 Mar 2020
Roche begins shipments of first 400,000 COVID-19 tests to laboratories across US to begin patient testing under FDA Emergency Use Authorization
Diagnostics Product Launch

HSMN NewsFeed - 3 Mar 2020
DxTerity Receives CE Mark for DxCollect(R) Fingerstick Blood RNA Stabilization Device
Devices Diagnostics Regulatory

HSMN NewsFeed - 10 Jan 2020
ProciseDx(TM) Announces CE Mark for Point of Care Inflammatory Marker Assay
Diagnostics Regulatory

HSMN NewsFeed - 4 Dec 2019
Accelerate Diagnostics Announces Executive Transition: Lawrence Mehren to Retire as Chief Executive Officer; Jack Phillips Appointed as Successor
Diagnostics Personnel

HSMN NewsFeed - 4 Nov 2019
Accelerate Diagnostics Appoints Roland Diggelmann to its Board of Directors
Diagnostics Personnel

HSMN NewsFeed - 30 Oct 2019
European Commission Approves Astellas' XOSPATA(TM) for Patients with Relapsed or Refractory Acute Myeloid Leukemia with Mutations Detected using Invivoscribe's LeukoStrat(R) CDx FLT3 Mutation Assay
Diagnostics Oncology Regulatory

HSMN NewsFeed - 18 Oct 2019
FDA Clears ORTHO(TM) Sera ID-MTS for Use on the ORTHO VISION(R) Analyzer
Diagnostics FDA

HSMN NewsFeed - 5 Aug 2019
Instrumentation Laboratory Presents New GEM Premier ChemSTAT(TM) Testing System With iQM(R) At American Association For Clinical Chemistry Annual Meeting
Diagnostics Product Launch

HSMN NewsFeed - 29 Jul 2019
RenalytixAI Appoints Thomas McLain as President and Chief Commercial Officer
Diagnostics Personnel

HSMN NewsFeed - 23 Jul 2019
Ortho Receives CE Mark for Enhanced VITROS(R) Immunodiagnostic Products NT-proBNP II Assay, an Aid in Diagnosing and Assessing Heart Failure
Diagnostics Cardiology Regulatory

HSMN NewsFeed - 16 May 2019
GenePOC Obtains FDA Clearance for its GenePOC(TM) Carba Test in the US
Diagnostics FDA

HSMN NewsFeed - 3 May 2019
Caris Life Sciences Receives FDA Breakthrough Device Designation for MI Transcriptome(TM) Companion Diagnostic Test
Diagnostics Oncology FDA

HSMN NewsFeed - 30 Apr 2019
510(k) Market Clearance for FluChip-8G Influenza A+B Assay
Diagnostics FDA

HSMN NewsFeed - 30 Apr 2019
Enzyre Appoints Dirk Pollet as Chief Executive Officer
Diagnostics Personnel

HSMN NewsFeed - 18 Apr 2019
Beckman Coulter's Early Sepsis Indicator Receives 510(k) Clearance from the U.S. Food and Drug Administration
Devices Diagnostics FDA

HSMN NewsFeed - 9 Apr 2019
FDA Clears VITROS(R) XT Chemistry Product Slides from Ortho Clinical Diagnostics
Diagnostics FDA

HSMN NewsFeed - 6 Mar 2019
Instrumentation Laboratory Receives US FDA Clearance For New Gem Premier Chemstat(TM) Testing System
Diagnostics FDA

HSMN NewsFeed - 20 Feb 2019
HemoCue Announces FDA 510(k) Clearance and U.S. Launch of Its Latest Point-of-Care Hemoglobin Test, the HemoCue(R) Hb 801 System
Diagnostics FDA Product Launch

HSMN NewsFeed - 30 Jan 2019
Magnolia Medical Announces $20 Million Series C Financing
Devices Venture Capital Personnel

HSMN NewsFeed - 2 Jan 2019
ImaginAb Announces Strengthening of Board and Executive Leadership Team
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 28 Nov 2018
FDA Approves Expanded Use for Ortho Clinical Diagnostics VITROS(R) HIV Combo Test
Devices Diagnostics HIV/AIDS FDA

HSMN NewsFeed - 6 Nov 2018
FDA Approves Ortho Clinical Diagnostics VITROS(R) Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator for use on the VITROS(R) 5600 Integrated System
Diagnostics HIV/AIDS FDA

HSMN NewsFeed - 24 Oct 2018
Inova Diagnostics Launches First FDA Cleared Calprotectin Extraction Device
Devices Diagnostics FDA Product Launch

HSMN NewsFeed - 17 Oct 2018
Thermo Fisher Scientific CE Marks Oncomine Dx Target Test
Diagnostics Oncology Regulatory

HSMN NewsFeed - 9 Oct 2018
Agendia Announces Level 1 Inclusion of MammaPrint(R) Breast Cancer Test in Updated National Comprehensive Cancer Network(R) (NCCN) Guidelines
Diagnostics Oncology Personalized Medicine

HSMN NewsFeed - 18 Sep 2018
Agendia and Genecast Biotechnology Partner to Launch MammaPrint(R) and BluePrint(R) in China
Diagnostics Personalized Medicine Oncology Product Launch

HSMN NewsFeed - 30 Aug 2018
Steripath Gen2, Next Generation Initial Specimen Diversion Device, Offers An Advanced Approach to Virtually Eliminating Blood Culture Contamination
Devices Product Launch

HSMN NewsFeed - 23 Aug 2018
Roche receives FDA approval for cobas EGFR Mutation Test v2 as companion diagnostic with IRESSA (gefitinib) in first-line treatment of patients with non-small cell lung cancer (NSCLC)
Diagnostics Oncology FDA

HSMN NewsFeed - 25 Jul 2018
SeraCare Announces the Expansion of Their Proprietary AccuPlex(TM) Technology Product Portfolio with the Launch of the AccuSpan(TM) HCV RNA Linearity Panel
Diagnostics Product Launch

HSMN NewsFeed - 16 Jul 2018
Ortho Clinical Diagnostics Launches New MicroTip Partnership Assays for Diabetes, Cardiac and Renal Testing, In Collaboration with Diazyme Laboratories, Inc.
Diagnostics Product Launch

HSMN NewsFeed - 25 Jun 2018
Beckman Coulter Files a 510(k) Submission with the FDA for Its Early Sepsis Indicator*
Diagnostics FDA

HSMN NewsFeed - 11 Jun 2018
Roche introduces first self-testing device for Warfarin monitoring with built in Bluetooth(R) technology
Devices Monitoring Product Launch

HSMN NewsFeed - 31 May 2018
Abbott Introduces the Afinion(TM) 2 Analyzer Rapid Test System for Diabetes Management
Diagnostics Endocrinology Product Launch

HSMN NewsFeed - 14 May 2018
FDA approves additional claim for Roche cobas Zika test
Diagnostics FDA

HSMN NewsFeed - 1 May 2018
Beckman Coulter Launches the DxH 900 Hematology Analyzer
Devices Diagnostics Product Launch

HSMN NewsFeed - 1 May 2018
Agendia's MammaPrint(R) Receives Positive Coverage Decisions from Three Major Private Healthcare Insurers
Diagnostics Personalized Medicine Oncology Reimbursement

HSMN NewsFeed - 23 Apr 2018
Surmodics Announces FDA Clearance of a New .018” Low-Profile PTA Balloon Dilation Catheter
Devices Interventional FDA

HSMN NewsFeed - 16 Apr 2018
Roche receives FDA clearance for cobas(R) CT/NG for cobas(R) 6800/8800 Systems
Diagnostics FDA

HSMN NewsFeed - 8 Mar 2018
Roche launches the new cobas m 511 analyzer, signaling a new era in hematology testing
Diagnostics FDA Product Launch

HSMN NewsFeed - 6 Mar 2018
FDA authorizes, with special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes
Diagnostics Oncology FDA

HSMN NewsFeed - 27 Feb 2018
Abbott and Surmodics Announce Agreement for Next-Generation Drug-Coated Balloon
Devices Interventional Licensing

HSMN NewsFeed - 15 Feb 2018
Viz.ai Granted De Novo FDA Clearance for First Artificial Intelligence Triage Software
Devices Radiology Neurology FDA

HSMN NewsFeed - 12 Jan 2018
FDA warns Becton Dickinson & Company of significant violations of the law as part of ongoing investigation into lead testing issues
Devices FDA

HSMN NewsFeed - 8 Jan 2018
Clearbridge BioMedics' ClearCell(R) FX1 system achieves U.S. FDA listing
Devices Diagnostics Oncology FDA

HSMN NewsFeed - 4 Jan 2018
Personal Genome Diagnostics Raises $75 Million to Bring Regulated IVD Genomic Tests to Cancer Patients Worldwide
Diagnostics Oncology Venture Capital

HSMN NewsFeed - 22 Dec 2017
FDA clears stereotactic radiotherapy system for use in treating breast cancer
Devices Oncology FDA

HSMN NewsFeed - 18 Dec 2017
FDA Approves Ortho Clinical Diagnostics VITROS(R) Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator on the VITROS(R) 3600 Immunodiagnostic System
Diagnostics HIV/AIDS FDA

HSMN NewsFeed - 28 Nov 2017
GenePOC Launches its GenePOC(TM) CDiff Test in the United States
Diagnostics FDA Product Launch

HSMN NewsFeed - 18 Sep 2017
Tetracore(R) Inc. Announces European Approval of the T-COR 8(TM) Portable Real-time PCR Thermocycler
Diagnostics Regulatory

HSMN NewsFeed - 5 Sep 2017
Morphotek(R), Inc. Announces an Agreement with Fujirebio Diagnostics, Inc. to Commercialize the CA125 II Assay as a Companion Diagnostic for Farletuzumab(R)
Biopharmaceuticals Diagnostics Oncology Licensing

HSMN NewsFeed - 26 Jul 2017
Roche Launches the Avenio Millisect System for Precise and Efficient Dissection of Tissue Biopsies
Diagnostics Product Launch

HSMN NewsFeed - 25 Jul 2017
ERBA Diagnostics, Inc. Appoints David Barka as Interim Chief Executive Officer, Nikhil Vazirani as Member of the Board
Diagnostics Personnel

HSMN NewsFeed - 24 Jul 2017
Luminex Corporation Receives FDA Clearance for ARIES C. difficile Assay
Diagnostics FDA

HSMN NewsFeed - 19 Jul 2017
BD Receives FDA 510(k) Clearance for New Immunological Diagnostic System
Devices Diagnostics FDA

HSMN NewsFeed - 11 Jul 2017
Sysmex America, Inc. Announces Launch of XN-L(TM) Automated Hematology Analyzers in U.S.
Diagnostics Product Launch

HSMN NewsFeed - 29 Jun 2017
HYCOR Biomedical Announces Senior Level Appointments to Management Team
Diagnostics Personnel

HSMN NewsFeed - 29 Jun 2017
Agena Bioscience Launches CE-IVD System For Hospitals And Diagnostic Laboratories In Europe
Diagnostics Product Launch

HSMN NewsFeed - 28 Jun 2017
Luminex Corporation Receives CE-IVD Mark for ARIES(R) Norovirus Assay
Diagnostics Regulatory

HSMN NewsFeed - 1 Jun 2017
Roche announces FDA approval of companion diagnostic to identify ALK-positive non-small cell lung cancer patients
Diagnostics Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 3 May 2017
Luminex Corporation Receives FDA Clearance for ARIES Bordetella Assay
Diagnostics FDA

HSMN NewsFeed - 1 May 2017
FDA Clears Roche High-Volume Immunoassay Lab Testing Solution to Support Critical Medical Treatment Decisions
Diagnostics FDA

HSMN NewsFeed - 14 Apr 2017
Abbott and Alere Amend Terms of Merger Agreement
Biopharmaceuticals Diagnostics Mergers & Acquisitions

HSMN NewsFeed - 12 Apr 2017
Roche Launches Antibody Test to Aid in Diagnosis of Challenging Prostate Cancer Cases
Diagnostics Oncology Product Launch

HSMN NewsFeed - 24 Feb 2017
Accelerate Diagnostics Receives FDA Marketing Authorization for the Accelerate Pheno(TM) System and Accelerate PhenoTest(TM) BC Kit
Diagnostics FDA

HSMN NewsFeed - 20 Feb 2017
DiaCarta Receives CE-IVD for its Non-Invasive Colorectal Cancer Test - ColoScape(TM) Real-Time PCR Kit
Diagnostics Oncology Regulatory

HSMN NewsFeed - 17 Jan 2017
Personal Genome Diagnostics Adds James Lewis as Senior Vice President of Corporate Development
Diagnostics Oncology Personalized Medicine Personnel

HSMN NewsFeed - 14 Nov 2016
Technopath Clinical Diagnostics Launches its First Diagnostic Reagent Product, the i-plaq(TM) Test for Lp-PLA2
Diagnostics Cardiology Product Launch

HSMN NewsFeed - 7 Nov 2016
Myriad Will Seek Japanese Regulatory Approval for BRACAnalysis CDx(R)
Diagnostics Oncology Regulatory

HSMN NewsFeed - 31 Oct 2016
BD MAX(TM) Vaginal Panel Receives FDA Market Authorization to Detect Most Common Causes of Vaginal Infections
Diagnostics FDA

HSMN NewsFeed - 28 Oct 2016
FDA Clears VITROS(R) Automation Solutions from Ortho Clinical Diagnostics
Diagnostics FDA Product Launch

HSMN NewsFeed - 24 Oct 2016
Personal Genome Diagnostics Launches RNAcomplete(TM) Allowing Co-Extraction and Analysis of RNA and DNA from a Single FFPE Tissue Sample
Diagnostics Oncology Product Launch

HSMN NewsFeed - 19 Oct 2016
GeneFirst Announces CE Marking and Release of Papilloplex(R) HR-HPV, a PCR Based Molecular Diagnostic Test for Genotyping 14 High Risk Human Papillomaviruses from Cervical and Urine Samples
Diagnostics Regulatory Product Launch

HSMN NewsFeed - 26 Sep 2016
Roche Receives 510(K) Clearance from FDA for Treponema Pallidum Assay to Aid Clinicians in the Diagnosis of Syphilis Infection
Diagnostics FDA

HSMN NewsFeed - 29 Aug 2016
Roche receives FDA Emergency Use Authorization for Zika PCR Test
Biopharmaceuticals FDA

HSMN NewsFeed - 2 Aug 2016
Ortho Clinical Diagnostics Announces Ortho Care
Diagnostics Product Launch

HSMN NewsFeed - 20 Jul 2016
Viracor-IBT Laboratories, Inc.'s Zika Virus RT-PCR Test Receives Emergency Use Authorization From the FDA
Diagnostics FDA

HSMN NewsFeed - 21 Jun 2016
Ortho Clinical Diagnostics Receives CE Mark Approval for VITROS(R) Immunodiagnostic HIV Combo Test*
Diagnostics Regulatory

HSMN NewsFeed - 8 Jun 2016
Beckman Coulter and Ortho Clinical Diagnostics Announce Strategic Relationship to Deliver Infectious Disease Testing Menu to Very High-Volume Labs
Diagnostics

HSMN NewsFeed - 25 May 2016
Roche announces the first FDA-approved CMV test for use in hematopoietic stem cell transplant recipients
Diagnostics FDA

HSMN NewsFeed - 23 Mar 2016
Roche Submits Filing to FDA For cobas(R) Procalcitonin (Pct) Assay to Help Clinicians Assess Response of Septic Patients to Treatment
Biopharmaceuticals FDA

HSMN NewsFeed - 21 Mar 2016
FDA approves expanded use of Roche hepatitis C virus RNA test as aid in diagnosis
Diagnostics FDA

HSMN NewsFeed - 15 Feb 2016
Collaboration led by ImmunID Awarded Innovate UK Grant to Advance Program on Prediction of Response to Cancer Immunotherapy using ImmunTraCkeR(R)
Diagnostics Personalized Medicine Oncology

HSMN NewsFeed - 9 Feb 2016
Aytu BioScience Announces First Commercial Sales for Company's MiOXSYS(TM) System for Male Infertility
Devices Urology Product Launch

HSMN NewsFeed - 1 Feb 2016
Abbott to Acquire Alere, Becoming Leader in Point of Care Testing and Significantly Advancing Global Diagnostics Presence
Devices Diagnostics Mergers & Acquisitions

HSMN NewsFeed - 29 Jan 2016
District Court Dismisses Lawsuit Against Accelerate Diagnostics
Diagnostics Litigation

HSMN NewsFeed - 12 Jan 2016
Aytu BioScience Obtains CE Marking for Company's MiOXSYS(TM) System for Male Infertility
Biopharmaceuticals Urology Regulatory

HSMN NewsFeed - 11 Jan 2016
SurModics Acquires NorMedix, a Design and Development Company Focused on Minimally Invasive Catheter Technologies
Devices Diagnostics Mergers & Acquisitions

HSMN NewsFeed - 22 Dec 2015
SurModics Announces Device Veteran Shawn McCormick Joins Board of Directors
Devices Diagnostics Personnel

HSMN NewsFeed - 21 Dec 2015
Roche receives FDA approval for HIV-1 viral load test on the cobas(R) 6800/8800 Systems
Diagnostics HIV/AIDS FDA

HSMN NewsFeed - 1 Dec 2015
Roche And Upsher-Smith Announce License Agreement To Develop Novel VAP-1 Inhibitor
Biopharmaceuticals Licensing

HSMN NewsFeed - 16 Sep 2015
Tokai Pharmaceuticals Augments Commercialization Capabilities through Appointment of Lisa Taylor as Senior Vice President, Commercial Development
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 3 Aug 2015
Orasure Technologies Receives FDA Emergency Use Authorization for Ebola Rapid Diagnostic Test
Diagnostics FDA

HSMN NewsFeed - 16 Jun 2015
William Annett Named Chief Executive Officer of OncoCyte Corporation
Diagnostics Oncology Personnel

HSMN NewsFeed - 11 Jun 2015
Biontech Launches Mammatyper(R) Breast Cancer Diagnostic Test in Europe
Diagnostics Personalized Medicine Oncology Product Launch

HSMN NewsFeed - 10 Jun 2015
Panasonic Healthcare and Bayer Diabetes Care to Create Leading Global Diabetes Care Solutions Business
Biopharmaceuticals Endocrinology Mergers & Acquisitions

HSMN NewsFeed - 26 May 2015
Roche receives FDA clearance for the cobas(R) Cdiff Test to detect Clostridium difficile
Diagnostics FDA

HSMN NewsFeed - 11 May 2015
Roche Receives FDA Approval for cobas(R) KRAS Mutation Test
Diagnostics Oncology FDA

HSMN NewsFeed - 17 Apr 2015
Accelerate Diagnostics Announces New Leadership Appointments
Diagnostics Personnel

HSMN NewsFeed - 3 Apr 2015
Bruker Announces FDA Clearance for Second, Expanded Claim for the MALDI Biotyper CA System
Diagnostics FDA

HSMN NewsFeed - 31 Mar 2015
EDP Biotech Signs Distribution Partnership Agreements for ColoMarker(R) Abroad
Diagnostics Oncology Distribution

HSMN NewsFeed - 26 Jan 2015
Roche receives FDA clearance for next generation cobas MRSA/SA Test
Diagnostics FDA

HSMN NewsFeed - 29 Dec 2014
Roche receives FDA Emergency Use Authorization for the LightMix(R) Ebola Zaire rRT-PCR Test
Diagnostics

HSMN NewsFeed - 1 Dec 2014
Cepheid Receives FDA Clearance for Xpert Norovirus, the First On-Demand Molecular Test for Detection of Norovirus
Diagnostics FDA

HSMN NewsFeed - 14 Aug 2014
Vermillion Announces Additions to Commercial Management Team
Diagnostics Personnel

HSMN NewsFeed - 6 Aug 2014
Tufts Medical Center and ATON Partners Announce Formation of CereVasc, LLC
Devices Neurosurgery

HSMN NewsFeed - 28 Jul 2014
Quidel Receives FDA Clearance for Its Hand-Held Molecular Diagnostic Test for Group A Strep
Diagnostics FDA

HSMN NewsFeed - 20 Jun 2014
ERBA Diagnostics, Inc. Appoints William Creech as Vice President Sales and Marketing
Diagnostics Personnel

HSMN NewsFeed - 16 Jun 2014
Agena Bioscience Announces FDA 510(k) Premarket Clearance of the IMPACT Dx(TM) Factor V Leiden and Factor II Genotyping Test on the IMPACT Dx(TM) System
Diagnostics FDA

HSMN NewsFeed - 28 Apr 2014
Vermillion Launches ASPiRA LABS
Diagnostics Personalized Medicine Oncology

HSMN NewsFeed - 24 Apr 2014
FDA Approves Roche's HPV Test for First-Line Primary Screening for Cervical Cancer
Diagnostics Oncology FDA

HSMN NewsFeed - 14 Apr 2014
Abbott Announces FDA Clearance for a New Test to Help Physicians Quickly and Accurately Diagnose Diabetes
Diagnostics Endocrinology FDA

HSMN NewsFeed - 9 Apr 2014
Patrick Roche, Ph.D. Joins HTG Molecular Diagnostics
Diagnostics Personnel

HSMN NewsFeed - 2 Apr 2014
Luoxis Obtains CE Marking for RedoxSYS(TM) Diagnostic System
Diagnostics Regulatory

HSMN NewsFeed - 31 Mar 2014
Johnson & Johnson Announces Acceptance Of Binding Offer From The Carlyle Group To Acquire Ortho-Clinical Diagnostics
Diagnostics Mergers & Acquisitions

HSMN NewsFeed - 22 Jan 2014
LipoScience Announces Appointment of Howard Doran as President and Chief Executive Officer
Diagnostics Personalized Medicine Personnel

HSMN NewsFeed - 16 Jan 2014
The Carlyle Group Agrees to Acquire Johnson & Johnson’s Ortho-Clinical Diagnostics for $4.15 Billion
Diagnostics Mergers & Acquisitions

HSMN NewsFeed - 16 Jan 2014
Johnson & Johnson Announces Binding Offer From The Carlyle Group To Acquire Ortho-Clinical Diagnostics
Diagnostics Mergers & Acquisitions

HSMN NewsFeed - 27 Nov 2013
Atlas Appoints David Whitaker as Operations Director
Diagnostics Personnel

HSMN NewsFeed - 20 Sep 2013
SurModics Announces Board Changes
Devices Personnel

HSMN NewsFeed - 4 Sep 2013
New Data Suggests Abbott's High Sensitive Troponin Test May Help Doctors More Accurately Diagnose Heart Attacks in Women
Diagnostics Cardiology

HSMN NewsFeed - 27 Aug 2013
BD ProbeTec(TM) Trichomonas vaginalis Q(x) Assay Launches on the BD Viper(TM) System with XTR(TM) Technology in the United States
Diagnostics FDA Product Launch

HSMN NewsFeed - 7 Aug 2013
Caldera Pharmaceuticals, Inc. and XRpro Corp Appoint Gary G. Altman as President, CEO and Member of Board of Directors
Biopharmaceuticals Personnel

HSMN NewsFeed - 23 Jul 2013
Instrumentation Laboratory Launches HemosIL(R) FDP Assay In Europe, Asia And Other International Regions
Diagnostics Product Launch

HSMN NewsFeed - 17 Jun 2013
Siemens to Create Companion Diagnostic Test for In-Development Janssen Heart Failure Drug
Diagnostics Personalized Medicine Cardiology

HSMN NewsFeed - 9 May 2013
BG Medicine Appoints Dr. Paul Sohmer as Chief Executive Officer
Diagnostics Cardiology Personnel

HSMN NewsFeed - 9 May 2013
Abbott Announces CE Mark for Test to Aid Doctors with Diagnosing and Monitoring Diabetes
Diagnostics Endocrinology Regulatory

HSMN NewsFeed - 16 Apr 2013
Abbott Introduces Next Generation Laboratory Automation Solution to Help Meet Increased Testing Demand
Diagnostics Product Launch

HSMN NewsFeed - 13 Mar 2013
Vermillion Appoints Thomas McLain as President and Chief Executive Officer
Diagnostics Oncology Personnel

HSMN NewsFeed - 18 Feb 2013
Roche and Chiasma Announce Collaboration to Develop and Commercialize Chiasma's Octreolin(R) for Acromegaly and Neuroendocrine Tumors
Biopharmaceuticals Endocrinology Licensing

HSMN NewsFeed - 7 Feb 2013
ERBA Diagnostics, Inc. Appoints Mohan Gopalkrishnan V.P. Operations
Diagnostics Personnel

HSMN NewsFeed - 9 Jan 2013
Spinomix Closes a $ 3 Million Financing Round Led by Debiopharm Group
Diagnostics Venture Capital

HSMN NewsFeed - 4 Jan 2013
Predictive Biosciences Appoints Diagnostics Industry Veteran Pierre Cassigneul as Chief Executive Officer
Diagnostics Oncology Urology Personnel

HSMN NewsFeed - 20 Dec 2012
Venaxis Board Appoints Senior Diagnostics Executive to Board of Directors
Diagnostics Personnel

HSMN NewsFeed - 9 Nov 2012
Boulder Diagnostics Announces the European Market Launch of Its SpiroFind(TM) Lyme Disease Diagnostic Test
Diagnostics

HSMN NewsFeed - 22 Oct 2012
Vascular Solutions Launches R-Band(TM) Radial Hemostasis Device
Devices Interventional Cardiology

HSMN NewsFeed - 5 Sep 2012
LipoScience Receives FDA Clearance for Vantera Clinical Analyzer
Diagnostics Personalized Medicine Cardiology FDA

HSMN NewsFeed - 27 Aug 2012
SurModics Announces Resignation of Jeffrey Smith from the Board of Directors
Devices Personnel

HSMN NewsFeed - 10 Jul 2012
Abbott Announces New Test for the Management of Patients with Diabetes
Diagnostics Endocrinology Regulatory

HSMN NewsFeed - 2 Jul 2012
BG Medicine, Inc. Appoints Bill Densel, General Manager, CardioSCORE
Diagnostics Cardiology Personnel

HSMN NewsFeed - 5 Jun 2012
HYCOR Awarded with Novation Supplier Agreement
Diagnostics Group Purchasing

HSMN NewsFeed - 25 May 2012
Advanced Biological Laboratories' DeepChek(R) and ViroScore(R) Suite Clinical Genotyping Solutions For Personalized Treatment of HIV Receive CE Mark for In Vitro Diagnostic Use
Diagnostics HIV/AIDS Regulatory

HSMN NewsFeed - 24 May 2012
AspenBio Appoints Diagnostics Industry Veteran Don Hurd as Senior Vice President and Chief Commercial Officer
Diagnostics Personnel

HSMN NewsFeed - 16 May 2012
Roche and HYCOR Sign Global Distribution Agreement
Diagnostics Distribution

HSMN NewsFeed - 4 May 2012
New HydraSolve(TM) Lipoplasty System launched at American Society of Aesthetic Plastic Surgery Meeting
Devices Surgery

HSMN NewsFeed - 1 May 2012
Dr. Frank Basile Joins Miraca Life Sciences as President and Chief Executive Officer
Diagnostics Personnel

HSMN NewsFeed - 17 Apr 2012
QIAGEN Receives FDA Clearances for Rotor-Gene Q MDx Instrument and Compatible Influenza A/B Assay
Diagnostics FDA

HSMN NewsFeed - 28 Mar 2012
Kapil Dhingra, Former Head of Roche Oncology, Joins Exosome Diagnostics Board of Directors
Diagnostics Personalized Medicine Oncology Personnel

HSMN NewsFeed - 5 Mar 2012
diaDexus Launches PLAC(R) Test for Lp-PLA(2) Activity in Europe
Diagnostics Cardiology

HSMN NewsFeed - 22 Feb 2012
Integrated Diagnostics(R) Secures $10 Million Third Tranche of Series A Financing
Diagnostics Venture Capital

HSMN NewsFeed - 3 Feb 2012
Caris Diagnostics Announces Name Change to Miraca Life Sciences
Diagnostics

HSMN NewsFeed - 27 Jan 2012
Saladax Biomedical, Inc. Announces the Resignation of Edward L. Erickson as President and Chief Executive Officer
Diagnostics Personalized Medicine Personnel

HSMN NewsFeed - 27 Jan 2012
LipoScience Names Timothy J. Fischer Chief Operating Officer
Diagnostics Personnel

HSMN NewsFeed - 18 Jan 2012
diaDexus, Inc. Names Jean-Frederic Viret, Ph.D. Chief Financial Officer
Diagnostics Personnel

HSMN NewsFeed - 9 Jan 2012
BG Medicine, Inc. Appoints Eric Bouvier as Chief Executive Officer
Diagnostics Personnel

HSMN NewsFeed - 6 Dec 2011
Agendia Introduces the SYMPHONY(TM) Breast Cancer Profile With Paraffin Embedded Tissue
Diagnostics Personalized Medicine Oncology

HSMN NewsFeed - 30 Nov 2011
Abbott Receives FDA Clearance for New Test to Detect Vitamin D Levels
Diagnostics FDA

HSMN NewsFeed - 24 Oct 2011
Abbott's Genetic Test for Acute Myeloid Leukemia Prognosis Cleared by FDA
Diagnostics FDA

HSMN NewsFeed - 20 Sep 2011
Bristol-Myers Squibb and Saladax Biomedical Expand Collaboration for Diagnostic Assays for Alzheimer’s Disease
Diagnostics Neurology

HSMN NewsFeed - 20 Sep 2011
SurModics IVD Introduces A New BioFX(R) TMB Enhanced HRP Membrane Substrate
Diagnostics

HSMN NewsFeed - 23 Aug 2011
SurModics Announces Strategic Realignment of Business
Devices Interventional Drug Delivery Personnel

HSMN NewsFeed - 23 Aug 2011
IQuum Receives FDA 510(k) Clearance for Liat(TM) Influenza A/B Assay for Influenza Molecular Diagnostics in Approximately 20 Minutes
Diagnostics FDA

HSMN NewsFeed - 22 Aug 2011
FDA Clears Abbott's Genetic FISH Panel for Leukemia Patient Prognosis
Diagnostics Oncology FDA

HSMN NewsFeed - 19 Jul 2011
Dennis M. Flannelly Joins Phadia as Head of U.S. Marketing and Strategy
Diagnostics Personnel

HSMN NewsFeed - 19 Jul 2011
Roche acquires mtm laboratories AG, expanding offering in cervical cancer testing
Diagnostics Mergers & Acquisitions

HSMN NewsFeed - 15 Jun 2011
SurModics Comments on Johnson & Johnson Announcement
Devices Interventional Cardiology

HSMN NewsFeed - 18 May 2011
Abbott Receives FDA Approval for Molecular Test for Hepatitis C
Diagnostics FDA

HSMN NewsFeed - 2 May 2011
Saladax Biomedical, Inc. Announces European Commercialization Team
Diagnostics Personalized Medicine Personnel

HSMN NewsFeed - 27 Apr 2011
Instrumentation Laboratory Appoints Ramon E. Benet New Chief Executive Officer
Diagnostics Personnel

HSMN NewsFeed - 18 Mar 2011
Quest Diagnostics to Acquire Celera, Strengthening Position as World's Leading Innovator in Molecular Diagnostics and Development
Diagnostics Personalized Medicine Mergers & Acquisitions

HSMN NewsFeed - 8 Mar 2011
Sparton Corporation Completes Acquisition of Byers Peak for $4.35 Million; Jake Rost Appointed as Vice President and General Manager of Sparton Medical Systems
Devices Mergers & Acquisitions Personnel

HSMN NewsFeed - 22 Feb 2011
OraSure Technologies Receives FDA Approval for Its OraQuick(R) HCV Rapid Test Using Fingerstick Whole Blood
Diagnostics FDA

HSMN NewsFeed - 20 Jan 2011
Radient Pharmaceuticals Receives Updated European Union Certification for Onko-Sure(R); CE Mark Opens Large Market for Company's IVD Cancer Test
Diagnostics Regulatory

HSMN NewsFeed - 11 Jan 2011
EraGen Appoints Gregory D. Rodgers Vice President of Manufacturing
Diagnostics Personnel

HSMN NewsFeed - 4 Jan 2011
Accomplished Sales and Marketing Executive Joins OraSure Technologies Management Team
Diagnostics Personnel

HSMN NewsFeed - 29 Dec 2010
Radient Pharmaceuticals Signs Distribution Agreement With Hong Kong Based Bio-Asia Diagnostics Co. Ltd.
Diagnostics Distribution

HSMN NewsFeed - 8 Dec 2010
Prodesse ProAdeno+ Assay Cleared for US Marketing by FDA
Diagnostics FDA

HSMN NewsFeed - 1 Nov 2010
Ortho Clinical Diagnostics Receives FDA Clearance for Intact Parathyroid Hormone Assay
Diagnostics FDA

HSMN NewsFeed - 15 Oct 2010
SurModics Announces Organizational Changes to Reduce Cost Structure and Renew Focus on Business Units
Devices Drug Delivery Personnel

HSMN NewsFeed - 13 Oct 2010
Radient Pharmaceuticals and Provista Life Sciences Announce New Blood Test for Lung Cancer
Diagnostics Oncology

HSMN NewsFeed - 13 Oct 2010
Bio-Rad and Axis-Shield Announce FDA Clearance and U.S. Launch of an Anti-CCP Test for Rheumatoid Arthritis for Bio-Rad's BioPlex 2200 System
Diagnostics FDA

HSMN NewsFeed - 20 Sep 2010
Celera Signs Agreement with Abbott for Distribution of CE-marked KIF6 Test to Identify Patients at Risk of Coronary Heart Disease
Diagnostics Cardiology Distribution

HSMN NewsFeed - 16 Aug 2010
Radient Pharmaceuticals Strengthens Manufacturing Management; Hires Tenured Director of Onko-Sure Test Kit Manufacturing
Diagnostics Personalized Medicine Oncology Personnel

HSMN NewsFeed - 12 Aug 2010
Radient Pharmaceuticals Appoints Gary Giarratano as Director of North American Sales and Marketing
Diagnostics Personalized Medicine Oncology Personnel

HSMN NewsFeed - 29 Jul 2010
VaxGen and diaDexus Complete Merger
Diagnostics Cardiology Mergers & Acquisitions

HSMN NewsFeed - 27 Jul 2010
Instrumentation Laboratory Receives FDA Clearance for New Automated Total Bilirubin Assay on GEM Premier 4000 Critical Care Analyzer
Diagnostics FDA

HSMN NewsFeed - 22 Jul 2010
HYCOR Biomedical Announces Senior Executive Appointments
Diagnostics Personnel

HSMN NewsFeed - 21 Jul 2010
Radient Pharmaceuticals Announces Exclusive Distribution Agreement With AMDL Australia Pty Ltd.
Biopharmaceuticals Diagnostics Distribution

HSMN NewsFeed - 20 Jul 2010
Radient Pharmaceuticals Appoints Dr. Robert Beart Jr. MD to RPC's Board of Directors
Biopharmaceuticals Diagnostics Personnel

HSMN NewsFeed - 13 Jul 2010
Radient Pharmaceuticals Enters Into a Letter of Intent to Acquire Provista Diagnostics Inc.
Diagnostics Mergers & Acquisitions

HSMN NewsFeed - 9 Jul 2010
HYCOR Biomedical Announces Appointment of Richard Hockins as Vice President, Sales and Marketing
Diagnostics Personnel

HSMN NewsFeed - 25 Jun 2010
OraSure Technologies Receives FDA Approval for OraQuick(R) HCV Rapid Test, the First Rapid HCV Test Approved for Sale in the U.S.
Diagnostics FDA

HSMN NewsFeed - 21 Jun 2010
FDA Approves First-of-Its-Kind HIV Test Which Can Detect HIV Days Earlier Than Current U.S. Tests
Diagnostics HIV/AIDS FDA

HSMN NewsFeed - 15 Jun 2010
Epocal Announces FDA Clearance of Lactate Test
Diagnostics FDA

HSMN NewsFeed - 3 Jun 2010
Abbott Receives FDA Clearance for New Ovarian Cancer Test
Diagnostics Oncology FDA

HSMN NewsFeed - 1 Jun 2010
SurModics Announces Departure of CEO Bruce Barclay
Devices Personnel

HSMN NewsFeed - 19 May 2010
Abbott Receives FDA Approval for First Fully Automated Blood Test for 'Kissing Bug' Disease
Diagnostics FDA

HSMN NewsFeed - 10 May 2010
AltheaDx Announces Appointment of New CEO and President and Adds Dr. Ann Kessler to the Board of Directors
Personalized Medicine Diagnostics Personnel

HSMN NewsFeed - 31 Mar 2010
Abbott Submits Test to Aid in Identifying Patients at Risk of Developing Kidney Injury
Diagnostics FDA

HSMN NewsFeed - 30 Mar 2010
Hycor Biomedical Announces Appointment of Dick Aderman as President and CEO
Diagnostics Personnel

HSMN NewsFeed - 10 Mar 2010
Cylex(TM) Elects Richard A. Sandberg as Independent Director
Diagnostics Personnel

HSMN NewsFeed - 5 Mar 2010
Saladax Biomedical Closes $8 Million Series C Financing
Personalized Medicine Diagnostics Venture Capital

HSMN NewsFeed - 5 Mar 2010
SurModics Announces Organizational and Leadership Changes
Devices Personnel

HSMN NewsFeed - 4 Mar 2010
IVAX Diagnostics' Diamedix Subsidiary Signs Three Year Exclusive Distribution Agreement with Fumouze Diagnostics
Diagnostics Distribution

HSMN NewsFeed - 23 Feb 2010
Instrumentation Laboratory Receives 510(K) Clearance From FDA and Canadian License for HemosIL(R) D-Dimer HS 500 Assay
Diagnostics FDA Regulatory

HSMN NewsFeed - 8 Feb 2010
Banyan Biomarkers Announces New Chief Executive Officer
Diagnostics Neurology Personnel

HSMN NewsFeed - 8 Feb 2010
Abbott Submits New Automated Ovarian Cancer Test for U.S. Approval
Diagnostics Oncology FDA

HSMN NewsFeed - 3 Feb 2010
Linden Acquires Hycor Biomedical Business from Agilent Technologies
Diagnostics Acquisitions

HSMN NewsFeed - 19 Jan 2010
OraSure Technologies and Roche Diagnostics Sign Worldwide Commercialization Agreement for Fully Automated Oral Fluid Drugs of Abuse Assays
Diagnostics

HSMN NewsFeed - 14 Jan 2010
Abbott Receives European Regulatory Approval for New Ovarian Cancer Diagnostic Test
Diagnostics Regulatory Oncology

HSMN NewsFeed - 7 Jan 2010
Instrumentation Laboratory Awarded New Contract With Novation
Devices Group Purchasing

HSMN NewsFeed - 6 Jan 2010
T2 BioSystems Appoints Ken Toso Vice President, Product Development
Diagnostics Personnel

HSMN NewsFeed - 4 Jan 2010
Cepheid Receives FDA Emergency Use Authorization (EUA) for First 2009 H1N1 Influenza Assay for CLIA 'Moderate Complexity' Laboratories
Diagnostics FDA

HSMN NewsFeed - 17 Dec 2009
FDA Broadens Clearance for Agendia's MammaPrint(R)
Diagnostics Oncology FDA

HSMN NewsFeed - 17 Nov 2009
bioMerieux and GSK Sign Theranostics Agreement to Develop Predictive Test for Selecting Breast Cancer Treatment
Biopharmaceuticals Diagnostics Oncology

HSMN NewsFeed - 17 Nov 2009
Abbott to Develop New Heart Failure Test on ARCHITECT(R) Immunochemistry Diagnostics Platform
Diagnostics Cardiology

HSMN NewsFeed - 20 Oct 2009
FDA Approves New Test to Aid in the Diagnosis of Rheumatoid Arthritis
Diagnostics FDA

HSMN NewsFeed - 15 Oct 2009
Biocartis Raises EUR10 Million in Series A Financing Round
Diagnostics Venture Capital

HSMN NewsFeed - 14 Oct 2009
Ortho Clinical Diagnostics Receives FDA Approval for First Anti-HIV 1+2 Test for Use on Random Access, Integrated Laboratory Testing System
Diagnostics FDA HIV/AIDS

HSMN NewsFeed - 6 Oct 2009
SurModics Enters Ophthalmic License and Development Agreement with Roche and Genentech
Biopharmaceuticals Ophthalmology Drug Delivery Licensing

HSMN NewsFeed - 22 Sep 2009
Agendia Raises US $23 Million in Series E Financing
Diagnostics Venture Capital

HSMN NewsFeed - 22 Sep 2009
FDA Clears Sysmex XE-2100D Hematology Analyzer for Blood Processing Center Quality Control Release Testing
Diagnostics FDA

HSMN NewsFeed - 21 Sep 2009
Abbott Receives FDA Approval for First Fully Automated Blood Screening Test for HIV-1/HIV-2
Diagnostics HIV/AIDS FDA

HSMN NewsFeed - 5 Aug 2009
XDx Completes $14.4 Million Series G Financing
Diagnostics Venture Capital

HSMN NewsFeed - 29 Jul 2009
Response Biomedical Receives U.S. FDA 510(k) Market Clearance of Rapid Respiratory Syncytial Virus Test
Diagnostics FDA

HSMN NewsFeed - 13 Jul 2009
Monitoring Circulating Tumor Cells With the CellSearch(R) System Can Predict Prognosis in Metastatic Breast Cancer
Diagnostics Oncology

HSMN NewsFeed - 13 Jul 2009
IVAX Diagnostics, Inc. Signs Distribution Agreement with Augurix SA for the First Approved Rapid Test for Celiac Disease
Diagnostics Distribution

HSMN NewsFeed - 27 May 2009
Accumetrics, Inc. Announces European Distribution Channels for France, Austria, Switzerland, Netherlands, Belgium and Luxembourg
Diagnostics Cardiology Distribution

HSMN NewsFeed - 5 May 2009
Instrumentation Laboratory Launches ACL AcuStar(TM) Hemostasis Testing System
Diagnostics FDA

HSMN NewsFeed - 24 Apr 2009
An Independent Study Reports on the Utility of ImmuKnow(R), the Cylex(TM) Immune Cell Function Assay, for Monitoring Heart Transplant Recipients
Diagnostics Cardiology

HSMN NewsFeed - 23 Apr 2009
Banyan Biomarkers, Inc. Targets Protein Biomarkers to Detect Mild to Moderate Traumatic Brain Injury
Diagnostics Neurology

HSMN NewsFeed - 2 Apr 2009
Roche to Introduce New LightCycler(R) MRSA Advanced Test in the EU
Diagnostics Regulatory

HSMN NewsFeed - 31 Mar 2009
Cepheid Announces European Release of First On-Demand Molecular Pre-Surgical Screening Test for Simultaneous Detection of Methicillin-Sensitive and Resistant S. aureus
Diagnostics

HSMN NewsFeed - 30 Mar 2009
Inverness Medical Innovations Launches New FDA Cleared C. DIFF QUIK CHEK COMPLETE(TM) Rapid Test
Diagnostics

HSMN NewsFeed - 18 Feb 2009
Agendia Publishes Direct Evidence That MammaPrint Predicts Benefit of Chemotherapy in Breast Cancer
Diagnostics Oncology

HSMN NewsFeed - 11 Feb 2009
Abbott Receives FDA Clearance for New CELL-DYN(R) Emerald(TM) Hematology Instrument
Diagnostics FDA

HSMN NewsFeed - 11 Feb 2009
Adaltis Announces Changes to Board of Directors
Diagnostics Personnel

HSMN NewsFeed - 4 Feb 2009
Agendia's Breast Cancer Test MammaPrint(R) Standard of Care at Netherlands Cancer Institute - AVL
Diagnostics Oncology

HSMN NewsFeed - 27 Jan 2009
SurModics and Nexeon MedSystems to Collaborate on Development of Novel Stent System for Renal Artery Disease
Devices Interventional

HSMN NewsFeed - 26 Jan 2009
Sequenom Expands Molecular Diagnostics Portfolio with Acquisition of SensiGen
Diagnostics Acquisitions

HSMN NewsFeed - 31 Dec 2008
FDA Approves Most Comprehensive System to Test Donated Blood for HIV, Hepatitis B & Hepatitis C
Diagnostics FDA

HSMN NewsFeed - 23 Dec 2008
Beckman Coulter Announces FDA Clearance of UniCel(R) DxH 800
Devices Diagnostics FDA

HSMN NewsFeed - 12 Dec 2008
Agendia's MammaPrint(R) Predicts Response to Neoadjuvant Chemotherapy in Breast Cancer
Diagnostics Oncology

HSMN NewsFeed - 10 Nov 2008
Cepheid Launches First On-Demand Molecular Diagnostic Test for Clostridium Difficile Into European Market
Diagnostics

HSMN NewsFeed - 5 Nov 2008
OraSure Technologies to Sell OraQuick ADVANCE Rapid HIV-1/2 Antibody Test Directly to U.S. Hospitals
Diagnostics

HSMN NewsFeed - 4 Nov 2008
SurModics Acquires Drug Delivery Assets of PR Pharmaceuticals
Biopharmaceuticals Drug Delivery Acquisitions

HSMN NewsFeed - 30 Oct 2008
SurModics Licenses Hydrophilic Coating for Elixir's Drug-Eluting and Bare Metal Stent Delivery Systems
Devices Interventional Cardiology Licensing

HSMN NewsFeed - 28 Oct 2008
OraSure Technologies Files For FDA Approval of OraQuick Rapid Hepatitis C Test
Diagnostics

HSMN NewsFeed - 27 Oct 2008
Medingo Appoints Pete Wehrly as President and Chief Executive Officer and Establishes US-based Operations
Devices Endocrinology Personnel

HSMN NewsFeed - 8 Oct 2008
Pathwork Diagnostics Announces Key Additions to Management Team
Diagnostics Personnel

HSMN NewsFeed - 30 Sep 2008
Premier Awards Contract to Instrumentation Laboratory for Critical Care Portfolio
Diagnostics Group Purchasing

HSMN NewsFeed - 17 Sep 2008
Merck & Co., Inc. Discontinues License and Research Collaboration Agreement with SurModics
Biopharmaceuticals Drug Delivery Licensing

HSMN NewsFeed - 11 Sep 2008
bioMerieux Gains Critical Oncology and Theranostics Capabilities with the Acquisition of Molecular Diagnostics Company AviaraDx
Diagnostics Oncology Mergers & Acquisitions

HSMN NewsFeed - 10 Sep 2008
Brian W. Reid to Join OraSure Technologies as Vice President, International Sales
Diagnostics Personnel

HSMN NewsFeed - 28 Aug 2008
Instrumentation Laboratory Receives FDA Clearance to Expand the Intended Use of HemosIL(R) D-Dimer Assay
Diagnostics FDA

HSMN NewsFeed - 27 Aug 2008
XDx's AlloMap(R) Gene Expression Test Cleared by U.S. Food and Drug Administration (FDA)
Diagnostics FDA

HSMN NewsFeed - 8 Aug 2008
EXACT Sciences Announces Next Generation Stool-based DNA Technology Study Results of 92% for Colorectal Cancer Detection
Diagnostics Gastroenterology Oncology

HSMN NewsFeed - 31 Jul 2008
FDA Clears the Pathwork(R) Tissue of Origin Test for Hard-To-Identify Tumors
Diagnostics Oncology FDA

HSMN NewsFeed - 30 Jul 2008
Escalon(R) Receives FDA 510(k) Clearance to Market the LIASYS(TM) Clinical Chemistry and Immunoturbidimetric Analyzer
Diagnostics FDA

HSMN NewsFeed - 21 Jul 2008
FDA Clears Osmetech's Warfarin Sensitivity Test and New eSensor(R) XT-8 Platform
Diagnostics FDA

HSMN NewsFeed - 16 Jul 2008
Alverix Appoints James D. Merselis as President and CEO
Devices Diagnostics Personnel

HSMN NewsFeed - 15 Jul 2008
Agendia and Ferrer Announce Exclusive Agreement for Sales of Cancer Diagnostic Services in Four Major European Markets
Diagnostics

HSMN NewsFeed - 8 Jul 2008
Power Medical Interventions, Inc. Files Special 510(k) for i45V 45mm Vascular Stapler and Reload Cartridge
Devices Surgery FDA

HSMN NewsFeed - 7 Jul 2008
BD Announces CE Marking of a New Molecular Test to Diagnose Patients with Clostridium difficile Infections
Diagnostics Regulatory

HSMN NewsFeed - 5 May 2008
ParagonDx Receives FDA 510(k) Marketing Clearance for Warfarin Sensitivity Genotyping Kit
Diagnostics FDA

HSMN NewsFeed - 17 Apr 2008
OraSure Technologies to Defend Patent Infringement Lawsuit
Diagnostics HIV/AIDS Litigation

HSMN NewsFeed - 17 Apr 2008
Response Biomedical Receives U.S. FDA 510(k) Market Clearance of Rapid Influenza A+B Test
Diagnostics FDA

HSMN NewsFeed - 17 Apr 2008
mtm laboratories Increases Series C Financing Round to Euro 31.6 Million (USD 50 Million)
Diagnostics Venture Capital

HSMN NewsFeed - 8 Apr 2008
Cylex Announces Brad L. Stewart as President of the Company
Diagnostics Personnel

HSMN NewsFeed - 31 Mar 2008
SurModics Announces First Human Use of SynBiosys(TM) Biodegradable Polymer on CardioMind Drug-Eluting Stent
Devices Interventional Cardiology

HSMN NewsFeed - 20 Mar 2008
Vermillion Announces Positive Results From Clinical Trial of Ovarian Tumor Triage Test; Study Meets Primary Endpoints
Diagnostics Oncology

HSMN NewsFeed - 13 Mar 2008
Biomarkers and Innovation Push Global Cancer Diagnostics Market Toward $8 Billion
Diagnostics Oncology

HSMN NewsFeed - 10 Mar 2008
Vermillion's Biomarkers Prove Beneficial in Identifying Women With Ovarian Cancer and Detecting Early-Stage Disease
Diagnostics Oncology

HSMN NewsFeed - 4 Mar 2008
FDA Grants Market Clearance to Aerocrine Inc.'s NIOX MINO(R): a New Hand-Held Device to Measure Airway Inflammation in Asthma
Devices FDA

HSMN NewsFeed - 25 Feb 2008
Cepheid and Instrumentation Laboratory Introduce Xpert(TM) HemosIL(R) FII & FV Assay to European Clinical Testing Market
Diagnostics

HSMN NewsFeed - 11 Feb 2008
Schering-Plough and OraSure Technologies Sign International Collaboration for Rapid Point-of-Care Oral Hepatitis C Test
Diagnostics

HSMN NewsFeed - 31 Jan 2008
Predictive Biosciences Appoints Martin Madaus, Millipore CEO and Chairman, to Board of Directors
Diagnostics Personnel

HSMN NewsFeed - 29 Jan 2008
SurModics Announces New Board Directors
Devices Drug Delivery Personnel

HSMN NewsFeed - 28 Jan 2008
SurModics Expands License Agreement with Merck & Co., Inc.
Biopharmaceuticals Drug Delivery Licensing

HSMN NewsFeed - 18 Jan 2008
Abbott Announces Approval of First Fully Automated Blood Screening Test for HTLV-I/HTLV-II
Diagnostics FDA

HSMN NewsFeed - 14 Jan 2008
Third Wave Responds to Court Ruling on Anti-Trust Claims in Digene Suit
Diagnostics Litigation

HSMN NewsFeed - 9 Jan 2008
Third Wave Announces Appointment of GE Healthcare Executive Christopher Burton as Senior Vice President of Sales and Marketing
Diagnostics Personnel

HSMN NewsFeed - 8 Jan 2008
Third Wave Announces First European HPV Distribution Partners
Diagnostics Distribution

HSMN NewsFeed - 3 Jan 2008
Luminex Corporation Receives U.S. Food and Drug Administration Clearance for xTAG(TM) Respiratory Viral Panel
Diagnostics FDA

HSMN NewsFeed - 2 Jan 2008
Debra Fraser-Howze to Join OraSure Technologies as Vice President, Government and External Affairs
Diagnostics Personnel

HSMN NewsFeed - 17 Dec 2007
MammaPrint(R) Breast Cancer Test Shown To Be Powerful Tool for Prognosis Prediction in Postmenopausal Breast Cancer Patients
Diagnostics Oncology

HSMN NewsFeed - 14 Dec 2007
Study Shows MammaPrint(R) Breast Cancer Test Provides Benefits to Patients from Personalized Treatment Regimen
Diagnostics Oncology

HSMN NewsFeed - 12 Dec 2007
Agendia's MammaPrint(R), the Only FDA-Cleared Breast Cancer Prognosis Test, is Now Widely Available to U.S. Patients
Diagnostics Oncology FDA

HSMN NewsFeed - 4 Dec 2007
Cepheid Launches New GeneXpert(R) Tests in Europe for Simultaneous, Rapid Detection of Staphylococcus Aureus and Methicillin Resistant Staphylococcus Aureus
Diagnostics

HSMN NewsFeed - 26 Nov 2007
Corgenix Releases Clinical Trial Data on AtherOx(TM)
Diagnostics

HSMN NewsFeed - 26 Nov 2007
CellSearch(TM) Circulating Tumor Cell Kit Receives FDA Clearance for Monitoring Patients with Metastatic Colorectal Cancer
Diagnostics FDA

HSMN NewsFeed - 14 Nov 2007
OraSure Technologies and Schering-Plough to Settle Patent Infringement Litigation
Biopharmaceuticals Litigation

HSMN NewsFeed - 6 Nov 2007
Siemens Completes Acquisition of Dade Behring
Diagnostics Mergers & Acquisitions

HSMN NewsFeed - 31 Oct 2007
SurModics and OakRiver Technology Collaborate on Advanced Coating Equipment
Devices

HSMN NewsFeed - 18 Oct 2007
FDA Clears bioMerieux's VIDAS(R) B.R.A.H.M.S PCT(R) Assay
Diagnostics FDA

HSMN NewsFeed - 15 Oct 2007
AMDL Submits Data to FDA for Clearance to Market Its DR-70(R) Diagnostic Test to Monitor Colorectal Cancer Patients
Diagnostics Oncology

HSMN NewsFeed - 9 Oct 2007
Instrumentation Laboratory Receives FDA Clearance to Expand the Intended Use for HemosIL(R) D-Dimer HS Assay
Diagnostics FDA

HSMN NewsFeed - 2 Oct 2007
Abbott Broadens Use of i-STAT Handheld Blood Analyzer with CLIA Waiver Granted by FDA for CHEM8+ Test Cartridge
Diagnostics FDA

HSMN NewsFeed - 1 Oct 2007
GE and Lilly Announce Research Collaboration to Co-Develop Molecular In Vitro Diagnostics for Cancer Treatments
Diagnostics Oncology

HSMN NewsFeed - 1 Oct 2007
bioMerieux Launches VIDAS(R) NT-proBNP, an Aid for Diagnosis and Prognosis of Heart Failure
Diagnostics Cardiology Regulatory

HSMN NewsFeed - 25 Sep 2007
Instrumentation Laboratory Receives FDA Clearance for HemosIL RecombiPlasTin 2G Assay
Diagnostics FDA

HSMN NewsFeed - 18 Sep 2007
AdvanDx Closes $15 Million Series C Financing Round From bioMerieux, LD Pensions and SLS Venture
Diagnostics Venture Capital

HSMN NewsFeed - 29 Aug 2007
ParagonDx Prepares Molecular Diagnostics Expansion After Acquisition of Gentris Diagnostics, Inc.
Diagnostics Mergers & Acquisitions Personnel

HSMN NewsFeed - 15 Aug 2007
Future Lies in Service for In Vitro Diagnostic Equipment Manufacturers
Diagnostics

HSMN NewsFeed - 13 Aug 2007
SurModics Acquires BioFX Laboratories
Diagnostics Mergers & Acquisitions

HSMN NewsFeed - 8 Aug 2007
Haemonetics(R) Announces Expanded Roles for Executive Management
Devices Personnel

HSMN NewsFeed - 30 Jul 2007
Corgenix Submits 510(k) Filing for IgG Anti-AtherOx(TM) Test Kit
Diagnostics FDA

HSMN NewsFeed - 18 Jul 2007
OraSure Technologies Appoints Vice President, Consumer Marketing
Diagnostics Personnel

HSMN NewsFeed - 12 Jul 2007
Abbott Announces Approval of First Fully-Automated Blood Screening Test for Hepatitis C Antibodies
Diagnostics FDA

HSMN NewsFeed - 11 Jun 2007
Response Biomedical Files for US FDA 510(k) Market Clearance of Rapid Influenza A+B Test
Diagnostics FDA

HSMN NewsFeed - 11 Jun 2007
OraSure Technologies Receives CE Mark for OraQuick ADVANCE(R) Rapid HIV Test
Diagnostics Regulatory HIV/AIDS

HSMN NewsFeed - 7 Jun 2007
In 2009 Exonhit Aims to ask for Market Clearance in Europe for a Blood Diagnostic Test for Alzheimer's Disease
Diagnostics Neurology

HSMN NewsFeed - 5 Jun 2007
EXACT Sciences and NorDiag Announce International Collaboration and License Agreement for Colorectal Cancer
Diagnostics Oncology Licensing

HSMN NewsFeed - 4 Jun 2007
Abbott Signs Agreement With Novation for Diagnostic Equipment and Tests
Diagnostics Group Purchasing

HSMN NewsFeed - 31 May 2007
AcroMetrix Receives 510(k) Clearance for VeriSure(R) Pro HBV Blood Screening Controls
Diagnostics FDA

HSMN NewsFeed - 23 May 2007
AdvanDx and bioMerieux Partner to Provide Rapid Results for Bloodstream Infections
Diagnostics

HSMN NewsFeed - 22 May 2007
Hana Biosciences Announces Vice President Appointment in Regulatory Affairs and Quality Assurance
Biopharmaceuticals Personnel

HSMN NewsFeed - 16 Apr 2007
Abbott and Premier Sign Contract for Diagnostic Tests
Diagnostics Group Purchasing

HSMN NewsFeed - 2 Apr 2007
OraSure Technologies Signs Agreement for Development of Counseling and Referral System for Home Use Rapid HIV Test Kit
Diagnostics

HSMN NewsFeed - 22 Mar 2007
Cepheid Introduces CE Mark Certified Smart HBV(TM) Test for SmartCycler(R) System
Diagnostics Regulatory

HSMN NewsFeed - 19 Mar 2007
Cepheid's Xpert(TM) EV Test for Enteroviral Meningitis, Run on the GeneXpert Platform, Receives FDA Clearance
Diagnostics FDA

HSMN NewsFeed - 5 Mar 2007
Corgenix Signs Licensing Agreement and Gains Full Rights to AspirinWorks(R) Aspirin Response Test
Diagnostics

HSMN NewsFeed - 15 Feb 2007
Cepheid Acquires Sangtec Molecular Diagnostics AB
Diagnostics Mergers & Acquisitions

HSMN NewsFeed - 6 Feb 2007
Agendia Receives U.S. FDA Clearance for MammaPrint Breast Cancer Diagnostic Test
Diagnostics FDA

HSMN NewsFeed - 17 Jan 2007
Cepheid and bioMerieux Enter Into Strategic Agreements to Develop and Market Sepsis and MRSA Products
Diagnostics

HSMN NewsFeed - 17 Jan 2007
bioMerieux Licenses Technology From Norchip to Launch a HPV Test For Cervical Cancer Risk Detection
Diagnostics Oncology Licensing

HSMN NewsFeed - 11 Jan 2007
Bio-Rad and Axis-Shield PLC Sign Agreement for Anti-CCP Test for Early Detection of Rheumatoid Arthritis
Diagnostics

HSMN NewsFeed - 8 Jan 2007
Abbott m2000(TM) Molecular Diagnostic Instrument and Viral Load Tests for HIV-1 and HCV Approved in Canada
Diagnostics Regulatory

HSMN NewsFeed - 4 Jan 2007
Schering-Plough and OraSure Technologies Sign Agreement for Development and Promotion of Rapid Point-of-Care Oral Hepatitis C Test
Diagnostics

HSMN NewsFeed - 3 Jan 2007
Third Wave Submits 510(k) to FDA for InPlex(TM) Cystic Fibrosis Molecular Test
Diagnostics

HSMN NewsFeed - 18 Dec 2006
Study Results Show GeneSearch(TM) Breast Lymph Node Assay Rapidly Detects Breast Cancer Metastases With Greater Sensitivity Than Traditional Tests
Diagnostics Oncology

HSMN NewsFeed - 27 Nov 2006
Otsuka Pharmaceutical Co., Ltd. Announces FDA Clearance for the RAPIRUN(R) H. pylori Antibody Detection Kit
Diagnostics FDA

HSMN NewsFeed - 8 Nov 2006
Instrumentation Laboratory Receives FDA Clearance for Homocysteine Assay
Diagnostics FDA

HSMN NewsFeed - 26 Oct 2006
Cepheid Extends European Product Line With Launch of Xpert(TM) MRSA Test for GeneXpert(R) System
Diagnostics

HSMN NewsFeed - 21 Oct 2006
HistoRx Announces Resignation of CEO & Co-Founder Robert A. Curtis
Diagnostics Personnel

HSMN NewsFeed - 20 Oct 2006
Abbott Signs Exclusive Worldwide Distribution Agreement With Verax Biomedical for Rapid Platelet Bacteria Test
Diagnostics Distribution

HSMN NewsFeed - 5 Oct 2006
OraSure Technologies Announces Director Appointments and Organizational Changes
Diagnostics Personnel

HSMN NewsFeed - 4 Oct 2006
Roche Diagnostics and OraSure Technologies Sign Letter of Intent to Develop Fully Automated Oral Fluid Drugs of Abuse Assays
Diagnostics

HSMN NewsFeed - 28 Sep 2006
Dade Behring Launches CardioPhase(R) hsCRP Test for Use on Its Stratus(R) CS Acute Care(TM) Diagnostic System
Diagnostics Cardiology

HSMN NewsFeed - 21 Sep 2006
Ciphergen Announces Data Supporting the Use of Protein Biomarkers to Improve Patient Diagnosis for Ovarian Cancer
Diagnostics Oncology

HSMN NewsFeed - 21 Jul 2006
Exagen Diagnostics Names Luc Van Hove Vice President, Quality, Regulatory, Medical Affairs and Chief Medical Officer
Diagnostics Personnel

HSMN NewsFeed - 21 Jul 2006
Exagen Diagnostics Creates an Executive Committee and Adds Corporate Controller
Diagnostics Personnel

HSMN NewsFeed - 21 Jul 2006
Exagen Diagnostics Adds Three Director-Level Employees
Diagnostics Personnel

HSMN NewsFeed - 19 Jul 2006
Abbott Announces FDA Clearance of Cell-Dyn Ruby(TM) Hematology Instrument
Diagnostics FDA

HSMN NewsFeed - 18 Jul 2006
Abbott Announces Approval of First Fully-Automated Blood Screening Tests for Hepatitis B Surface Antigen
Diagnostics FDA

HSMN NewsFeed - 27 Jun 2006
Abbott Enters Agreement With Cincinnati Children's Hospital to Develop Test to Detect Acute Kidney Failure
Diagnostics

HSMN NewsFeed - 31 May 2006
Fujirebio Diagnostics Acquires CanAg Diagnostics
Diagnostics Mergers & Acquisitions

HSMN NewsFeed - 16 May 2006
Abbott Enters Agreement With Advanced Life Science Institute to Develop Lung Cancer Test
Diagnostics Oncology

HSMN NewsFeed - 15 May 2006
Dade Behring Launches CardioPhase(R) hsCRP Test for Use on Its Dimension(R) Systems
Diagnostics Cardiology

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