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Tuesday, February 9, 2010
Volcano Receives FDA Clearance to Market the Eagle Eye(R) Platinum Digital IVUS Catheter
HSMN NewsFeed, 9 Feb 2010:   Devices, Interventional, FDA
[Volcano, Eagle Eye, IVUS catheter, IVUS imaging]

Clinical Study: Biologic Grafts Reduce Postoperative Pain While Creating a Repair as Durable as Synthetic Mesh in Treating Inguinal Hernias
HSMN NewsFeed, 9 Feb 2010:   Devices, Surgery
[Cook Medical, Biodesign, Inguinal Hernia Graft, synthetic mesh, hernioplasty]

FlowCardia, Inc. Initiates CENTRAL Study Enrollment
HSMN NewsFeed, 9 Feb 2010:   Devices, Interventional
[FlowCardia, chronic total occlusions, CENTRAL study, CROSSER Catheter]

Xencor Appoints Edgardo Baracchini, Ph.D., to Chief Business Officer
HSMN NewsFeed, 9 Feb 2010:   Biopharmaceuticals, Personnel
[Xencor]

Valtech Cardio Ltd. Announces Appointment of CEO -- Medtech Veteran Bruce H. KenKnight Joins Valtech Team
HSMN NewsFeed, 9 Feb 2010:   Devices, Cardiology, Personnel
[Valtech Cardio]

BioSante Pharmaceuticals Appoints Jeffrey W. Winkelman, Ph.D., J.D., Vice President, Oncology Programs
HSMN NewsFeed, 9 Feb 2010:   Biopharmaceuticals, Personnel
[BioSante Pharmaceuticals]

Adeona Appoints James S. Kuo, M.D., M.B.A., as Chairman, CEO and President
HSMN NewsFeed, 9 Feb 2010:   Biopharmaceuticals, Personnel
[Adeona Pharmaceuticals]

Debiopharm Group Grants an Exclusive Licence for the Development, Manufacture and Commercialisation of Debio 025
HSMN NewsFeed, 9 Feb 2010:   Biopharmaceuticals, Licensing
[Debiopharm, Novartis, Debio 025, alisporivir, hepatitis C]

Denosumab Demonstrated Superiority Over Zometa(R) in Pivotal Phase 3 Head-to-Head Trial in Prostate Cancer Patients With Bone Metastases
HSMN NewsFeed, 8 Feb 2010:   Biopharmaceuticals, Oncology
[Amgen, denosumab, Zometa, zoledronic, bone metastases]

Lupin Receives FDA Approval for Amlodipine/Benazepril Capsules
HSMN NewsFeed, 8 Feb 2010:   Biopharmaceuticals, FDA, Generics
[Lupin Pharmaceuticals, Amlodipine, Benazepril, Novartis, Lotrel]

Sagent Pharmaceuticals Announces FDA Approval of Labetalol Hydrochloride Injection, USP
HSMN NewsFeed, 8 Feb 2010:   Biopharmaceuticals, Generics, Cardiology, FDA
[Sagent Pharmaceuticals, labetalol, Prometheus Laboratories, Trandate]

Banyan Biomarkers Announces New Chief Executive Officer
HSMN NewsFeed, 8 Feb 2010:   Diagnostics, Neurology, Personnel
[Banyan Biomarkers, traumatic brain injury]

KineMed Broadens Collaboration with Bristol-Myers Squibb
HSMN NewsFeed, 8 Feb 2010:   Biopharmaceuticals, Personalized Medicine, Neurology
[KineMed, Bristol-Myers Squibb, Alzheimer’s disease]

Abbott Submits New Automated Ovarian Cancer Test for U.S. Approval
HSMN NewsFeed, 8 Feb 2010:   Diagnostics, Oncology, FDA
[Abbott, ARCHITECT HE4, HE4, ovarian cancer]

Aton Pharma Announces Michael H. Richardson to Head Orphan Drug Division
HSMN NewsFeed, 8 Feb 2010:   Biopharmaceuticals, Personnel
[Aton Pharma, Orphan Drug]

BD Announces Worldwide Voluntary Recall of BD Q-Syte(TM) Luer Access Devices and BD Nexiva(TM) Closed IV Catheter Systems
HSMN NewsFeed, 8 Feb 2010:   Devices, Product Recall
[ BD , Becton Dickinson, Q-Syte Luer Access, Nexiva Closed IV]

Neuraltus Pharmaceuticals Names Andrew Gengos President and CEO
HSMN NewsFeed, 8 Feb 2010:   Biopharmaceuticals, Personnel
[Neuraltus Pharmaceuticals]

Synovis Life Technologies Receives FDA Marketing Clearance for Flow Coupler(R)
HSMN NewsFeed, 8 Feb 2010:   Devices, Surgery, FDA
[Synovis Life Technologies, Flow Coupler, Microvascular Anastomotic Coupler]

Anthera Pharmaceuticals Announces Agreement With the FDA on a SPA for Planned Phase 3 Varespladib A-002 Study; Daniel K. Spiegelman Joins Board of Directors
HSMN NewsFeed, 8 Feb 2010:   Biopharmaceuticals, Cardiology, Personnel
[Anthera Pharmaceuticals, VISTA-16, Varespladib]

Stereotaxis Installs First System in Taiwan
HSMN NewsFeed, 8 Feb 2010:   Devices, Cardiology
[Stereotaxis, Magnetic Navigation System]

Novus Scientific Receives FDA Clearance for TIGR(TM) Matrix Surgical Mesh - World's 1st Long-Term Resorbable Synthetic Mesh
HSMN NewsFeed, 5 Feb 2010:   Devices, FDA
[Novus Scientific, TIGR Matrix, Surgical Mesh]

Study Suggests Slide-On(R) EndoSheath(R) System Provides Several Advantages over Traditional Germicidal Immersion
HSMN NewsFeed, 5 Feb 2010:   Devices
[Medtronic, Slide-On, EndoSheath]

Benefits of CyberKnife Radiosurgery for Lung Cancer Drive Continued Adoption
HSMN NewsFeed, 5 Feb 2010:   Devices, Oncology
[Accuray, CyberKnife, radiosurgery]

Teva Announces Settlement in Principle regarding Certain Drug Pricing Lawsuits
HSMN NewsFeed, 5 Feb 2010:   Biopharmaceuticals, Litigation
[Teva Pharmaceutical, Ven-A-Care]

Sorin Group Announces Market Release and First Implant of Next-Generation Cardiac Resynchronization Therapy Defibrillator
HSMN NewsFeed, 5 Feb 2010:   Devices, Cardiology
[Sorin Group, CRT-D, Paradym, cardiac resynchronization]

Amicus Therapeutics Board of Directors Names Chief Executive Officer John F. Crowley Chairman of the Board
HSMN NewsFeed, 5 Feb 2010:   Biopharmaceuticals, Personnel
[Amicus Therapeutics]

BioMarin to Acquire LEAD Therapeutics
HSMN NewsFeed, 4 Feb 2010:   Biopharmaceuticals, Mergers & Acquisitions, Oncology
[BioMarin Pharmaceutical, LEAD Therapeutics]

Elekta Expands Consultative Services Program to Help MOSAIQ Customers Demonstrate Meaningful Use Guidelines
HSMN NewsFeed, 4 Feb 2010:   Devices, Oncology
[Elekta, STRATEGIQ, HITECH Act]

Bioheart Launches First US FDA Approved Clinical Trial that Tests Gene-Modified Stem Cell Therapy in Patients with Congestive Heart Failure
HSMN NewsFeed, 4 Feb 2010:   Regenerative Medicine, Cardiology
[Bioheart, MyoCell, REGEN trial, stem cell]

ADVENTRX Announces Management Promotions
HSMN NewsFeed, 4 Feb 2010:   Biopharmaceuticals, Personnel
[ADVENTRX Pharmaceuticals]

NeurogesX Announces Management Team Promotions
HSMN NewsFeed, 4 Feb 2010:   Biopharmaceuticals, Personnel
[NeurogesX]

St. Jude Medical Announces European Approval of Smaller, Higher Power ICD and CRT-D Devices with New Heart Failure Monitors
HSMN NewsFeed, 4 Feb 2010:   Devices, Cardiology
[St. Jude Medical, Fortify ST, ICD , CRT-D]

Chimerix Names Wendy Painter, M.D., M.P.H., as Chief Medical Officer
HSMN NewsFeed, 4 Feb 2010:   Biopharmaceuticals, Personnel
[Chimerix]

American Shared Hospital Services Announces Contract to Supply a Leksell Gamma Knife Perfexion System to Methodist Hospital in San Antonio
HSMN NewsFeed, 4 Feb 2010:   Devices, Oncology, Neurosurgery
[Elekta, American Shared Hospital Services, Leksell Gamma Knife, Perfexion]

Toshiba Receives FDA Clearance for Viamo Ultrasound System
HSMN NewsFeed, 4 Feb 2010:   Devices, Radiology
[Toshiba America Medical Systems, Viamo, laptop ultrasound]

Launch of Ipsen's Decapeptyl(R) 6-Month Formulation (LP 22.5 mg) in France for the Treatment of Locally Advanced or Metastatic Hormone-Dependent Prostate Cancer
HSMN NewsFeed, 4 Feb 2010:   Biopharmaceuticals, Oncology
[Ipsen, Debiopharm, Decapeptyl, triptorelin embonate, prostate cancer]

Cardiac Science Notifies AED Customers of Voluntary Medical Device Recall
HSMN NewsFeed, 3 Feb 2010:   Devices, Product Recall
[Cardiac Science, automated external defibrillators, Powerheart, CardioVive]

Poniard Pharmaceuticals Announces Management Changes and Reduction in Force
HSMN NewsFeed, 3 Feb 2010:   Biopharmaceuticals, Personnel
[Poniard Pharmaceuticals]

Noven Appoints Patrick Gallagher as Vice President
HSMN NewsFeed, 3 Feb 2010:   Biopharmaceuticals, Personnel
[Noven Pharmaceuticals]

Penrose-St. Francis Health Systems adopts TandemHeart(R) - versatile circulatory support device from CardiacAssist
HSMN NewsFeed, 3 Feb 2010:   Devices, Cardiology
[CardiacAssist, TandemHeart, extracorporeal circulatory support]

Viroblock SA Hires Dr. Jamie Paterson as CEO and Closes Financing Round
HSMN NewsFeed, 3 Feb 2010:   Biopharmaceuticals, Personnel, Venture Capital
[Viroblock]

Scott Canute Joins Genzyme to Head Manufacturing and Corporate Operations
HSMN NewsFeed, 3 Feb 2010:   Biopharmaceuticals, Personnel
[Genzyme]

PSS World Medical Appoints Gary A. Corless as President and Chief Executive Officer
HSMN NewsFeed, 3 Feb 2010:   Devices, Personnel
[PSS World Medical]

Speedus Engages Morgan Joseph to Evaluate Strategic Alternatives for Zargis Subsidiary
HSMN NewsFeed, 3 Feb 2010:   Devices, Cardiology
[Zargis Medical, Speedus, Cardioscan]

NxStage(R) and Nordic Medcom Sign Distribution Agreement for the System One(TM)
HSMN NewsFeed, 3 Feb 2010:   Devices, Distribution
[NxStage Medical, Nordic Medcom, NxStage System One, hemodialysis]

Cymbalta(R) Significantly Reduced Chronic Low Back Pain in New Study
HSMN NewsFeed, 3 Feb 2010:   Biopharmaceuticals
[Eli Lilly, Cymbalta, duloxetine, back pain]

Medicis Receives Approval for RESTYLANE(R) and PERLANE(R) With Lidocaine
HSMN NewsFeed, 3 Feb 2010:   Devices, Dermatology, FDA
[Medicis Pharmaceutical, RESTYLANE, PERLANE, hyaluronic acid, dermal filler]

Linden Acquires Hycor Biomedical Business from Agilent Technologies
HSMN NewsFeed, 3 Feb 2010:   Diagnostics, Acquisitions
[Agilent Technologies, Hycor Biomedical, Linden LLC]

St. Jude Medical Announces IRASE AF Clinical Trial to Evaluate Cardiac Ablation Catheter System for Treatment of Atrial Fibrillation
HSMN NewsFeed, 3 Feb 2010:   Devices, Cardiology
[St. Jude Medical, tip irrigated ablation catheter, atrial fibrillation]

Sanomedics Names Jordan Serlin Chief Operating Officer
HSMN NewsFeed, 3 Feb 2010:   Devices, Personnel
[Sanomedics]

Acorda Therapeutics Announces Pricing and Patient Assistance Programs for AMPYRA (dalfampridine)
HSMN NewsFeed, 3 Feb 2010:   Biopharmaceuticals, Neurology
[Acorda Therapeutics, AMPYRA, dalfampridine, multiple sclerosis]

Silodosin (Urorec(R)/Silodyx) Approved by the European Commission for the Treatment of the Signs and Symptoms of BPH (Benign Prostatic Hyperplasia)
HSMN NewsFeed, 3 Feb 2010:   Biopharmaceuticals, Urology, Regulatory
[RECORDATI, Urorec, Silodyx, benign prostatic hyperplasia]

Medco Acquires Leading Genetics Healthcare Company, DNA Direct
HSMN NewsFeed, 2 Feb 2010:   Diagnostics, Personalized Medicine, Mergers & Acquisitions
[Medco Health Solutions, DNA Direct, genomic medicine]

Auxilium Announces U.S. Food and Drug Administration Approval for XIAFLEX(TM) for the Treatment of Dupuytren's Contracture
HSMN NewsFeed, 2 Feb 2010:   Biopharmaceuticals, FDA
[Auxilium Pharmaceuticals, XIAFLEX, Dupuytren's contracture]

Sensors for Medicine and Science, Inc. Names Dr. Paul Strumph as Chief Medical Officer
HSMN NewsFeed, 2 Feb 2010:   Devices, Monitoring, Endocrinology, Personnel
[Sensors for Medicine and Science, implanted continuous glucose monitor]

Two Studies Find Artefill(R) to Be a Long-Term Treatment Option for Facial Lipoatrophy
HSMN NewsFeed, 2 Feb 2010:   Devices, Dermatology
[Suneva Medical, Artefill, lipoatrophy]

Bio-Matrix Scientific Group's Majority Owned Subsidiary Entest BioMedical Initiates Studies to Support Stem Cell / Laser Regenerative Therapy for COPD
HSMN NewsFeed, 2 Feb 2010:   Regenerative Medicine
[Bio-Matrix Scientific Group, Entest BioMedical, stem cell, COPD]

Veran Medical Receives FDA Clearances to Expand Uses for ig4 Navigation System to Use Ultrasound and 3D Fluoroscopic X-ray
HSMN NewsFeed, 2 Feb 2010:   Devices, Oncology, FDA
[Veran Medical Technologies, ig4, electromagnetic navigation, thermal ablation]

FDA Accepts Javelin Pharmaceuticals' Submission and Files New Drug Application for Dyloject(TM)
HSMN NewsFeed, 2 Feb 2010:   Biopharmaceuticals, FDA, Mergers & Acquisitions
[Myriad Pharmaceuticals, Javelin Pharmaceuticals, Dyloject]

Addenbrooke's Hospital Begins Treating Patients on Second TomoTherapy(R) Cancer Treatment System
HSMN NewsFeed, 2 Feb 2010:   Devices, Oncology
[TomoTherapy, Hi-Art, radiotherapy, IMRT]

Alphatec Spine Receives CE Mark for its OsseoScrew(TM) Spinal Fixation System and Its GLIF/ ARC(TM) Portal Access System
HSMN NewsFeed, 2 Feb 2010:   Devices, Orthopaedic, Neurosurgery, Regulatory
[Alphatec Spine, OsseoScrew, Spinal Fixation, Guided Lumbar Interbody Fusion]

Guided Therapeutics, Inc. Receives New Funding Commitment from Konica Minolta Opto, Inc. to Expand Cancer Detection Product Line
HSMN NewsFeed, 2 Feb 2010:   Devices, Diagnostics, Oncology
[Guided Therapeutics, LightTouch, cervical cancer]

STAAR Surgical's Visian(R) ICL(TM) is First Phakic Lens to Be Approved in Japan
HSMN NewsFeed, 2 Feb 2010:   Devices, Ophthalmology, Regulatory
[STAAR Surgical, Visian, Implantable Collamer Lens, myopia]

Journal of American College of Cardiology Publishes Study Demonstrating Safety & Effectiveness of Laser Assisted Lead Removal
HSMN NewsFeed, 2 Feb 2010:   Devices, Cardiology
[Spectranetics, LExICon study, laser assisted lead removal]






 
     

 

 

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