Healthcare Sales & Marketing Network: FDA : Medical Device and Pharmaceutical News

Healthcare News Roundup: FDA

HSMN NewsFeed - 1 Aug 2014
FDA Approves Boehringer Ingelheim's Striverdi(R) Respimat(R) (olodaterol) Inhalation Spray for Maintenance Treatment of COPD
Biopharmaceuticals FDA

HSMN NewsFeed - 1 Aug 2014
MEDICREA’s K-JAWS(R) Obtains FDA Approval for Its Marketing in the United States
Devices Neurosurgery Orthopaedic FDA

HSMN NewsFeed - 31 Jul 2014
K2M Continues Momentum with Complex Spine & Minimally Invasive Line Extensions & Regulatory Clearances
Devices Neurosurgery Orthopaedic FDA Product Launch

HSMN NewsFeed - 29 Jul 2014
Teleflex Receives FDA Clearance for 150 cm Length Arrow(R) GPSCath(R) Balloon Dilatation Catheters
Devices Interventional FDA

HSMN NewsFeed - 29 Jul 2014
Intellijoint(TM) Wins FDA Clearance of New Instrument for Improving Hip Surgery
Devices Orthopaedic FDA

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

HSMN NewsFeed - 28 Jul 2014
New Chlamydia and Gonorrhea Assays on the BD Viper(TM) LT System Receive FDA 510k Clearance
Diagnostics FDA

HSMN NewsFeed - 28 Jul 2014
Aqua Pharmaceuticals, LLC Announces the U.S. Food and Drug Administration (FDA) Approval of ACTICLATE(TM) (doxycycline hyclate USP) Tablets, 150 mg and 75 mg
Biopharmaceuticals FDA

HSMN NewsFeed - 25 Jul 2014
Guided Therapeutics Files PMA Amendment with FDA for LuViva(R) Advanced Cervical Scan
Devices Diagnostics FDA

HSMN NewsFeed - 24 Jul 2014
Philips receives FDA 510(k) clearance for its innovative ultra mobile VISIQ ultrasound system
Devices FDA

HSMN NewsFeed - 23 Jul 2014
FDA Approves Eagle Pharmaceuticals’ Ryanodex(R) for the Treatment of Malignant Hyperthermia
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Jul 2014
Teleflex Receives FDA Clearance for ARROW-Clark(TM) VectorFlow(TM) Chronic Hemodialysis Catheter
Devices FDA

HSMN NewsFeed - 22 Jul 2014
FDA Grants Genentech’s Avastin Priority Review for Recurrent Platinum-Resistant Ovarian Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 21 Jul 2014
CorMatrix(R) Reports FDA Clearance of CorMatrix ECM(R) for Vascular Repair
Devices Regenerative Medicine FDA

HSMN NewsFeed - 21 Jul 2014
Varian Medical Systems Receives FDA 510(k) Clearance for Calypso(R) Soft Tissue Beacon(R) Transponder
Devices Oncology FDA

HSMN NewsFeed - 21 Jul 2014
Expanding Orthopedics Inc. has obtained FDA Clearance for its FLXfit(TM), the world's first 3D expandable interbody cage
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 17 Jul 2014
Bausch + Lomb's VICTUS(R) Femtosecond Laser Platform Receives 510(k) Clearance from FDA for Lens Fragmentation Procedure
Devices Ophthalmology FDA

HSMN NewsFeed - 17 Jul 2014
Salix and Pharming Announce FDA Approval of RUCONEST(R) for the Treatment of Acute Angioedema Attacks in Patients with Hereditary Angioedema (HAE)
Biopharmaceuticals FDA

HSMN NewsFeed - 15 Jul 2014
FDA Grants Genentech’s Avastin Priority Review for Certain Types of Cervical Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 14 Jul 2014
Titan Spine Receives FDA Clearance to Launch Endoskeleton(R) TL Device for Lateral Spinal Fusion
Devices Neurosurgery Orthopaedic FDA

HSMN NewsFeed - 3 Jul 2014
Akashi Therapeutics Receives Fast Track Designation for HT-100 from FDA for the Treatment of Duchenne Muscular Dystrophy
Biopharmaceuticals FDA

HSMN NewsFeed - 2 Jul 2014
Insys Therapeutics Receives FDA Orphan Drug Designation for Its Pharmaceutical Cannabidiol as a Potential Treatment for Dravet Syndrome, a Rare Form of Epilepsy
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 30 Jun 2014
Allergan Announces R&D Pipeline Update and U.S. FDA Approval; Company to Host Conference Call Today, Monday, June 30th at 10:30 AM ET
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 30 Jun 2014
Flamel Technologies Announces FDA Approval of VAZCULEP
Biopharmaceuticals FDA

HSMN NewsFeed - 18 Jun 2014
Solace Therapeutics Receives Two FDA Clearances towards Providing Women an Office-Based Treatment for Stress Urinary Incontinence (SUI).
Devices Urology FDA

HSMN NewsFeed - 18 Jun 2014
AngioDynamics Announces FDA Clearance for Celerity Tip Location System
Devices FDA

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 - 12 Jun 2014
FDA approves Bayer's Gadavist (gadobutrol) Injection as the first magnetic resonance contrast agent for evaluation of breast cancer in the United States
Biopharmaceuticals Radiology FDA

HSMN NewsFeed - 10 Jun 2014
Auxogyn Receives FDA Clearance for Its Eeva(TM) System
Devices FDA

HSMN NewsFeed - 10 Jun 2014
Pulsar Vascular Receives FDA IDE Approval for the PulseRider(R) Aneurysm Neck Reconstruction Device for the Treatment of Intracranial Bifurcation Aneurysms
Devices Interventional FDA

HSMN NewsFeed - 10 Jun 2014
Cohera Medical, Inc.(R)'s TissuGlu(R) Surgical Adhesive Advances to Food and Drug Administration Advisory Panel Meeting
Devices Surgery FDA

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