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

Healthcare News Roundup: FDA

HSMN NewsFeed - 1 Nov 2011
LDR Announces FDA Clearance of the ROI-A(R) Oblique ALIF Cage
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 31 Oct 2011
Cyberonics Receives FDA Approval for Expansion of MRI Use With VNS Therapy(R) Systems
Devices FDA

HSMN NewsFeed - 31 Oct 2011
FDA Approves Gen-Probe's APTIMA(R) HPV Assay, New Molecular Test to Detect Virus that Causes Cervical Cancer
Diagnostics Oncology FDA

HSMN NewsFeed - 31 Oct 2011
Pacira Pharmaceuticals, Inc. Announces U.S. FDA Approval of EXPAREL(TM) For Postsurgical Pain Management
Biopharmaceuticals FDA

HSMN NewsFeed - 28 Oct 2011
Spinal USA Gets FDA Approval for Two New Spinal Treatment Products
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 26 Oct 2011
St. Jude Medical Announces FDA Clearance of First and Only Combined FFR and OCT System
Devices Cardiology FDA

HSMN NewsFeed - 25 Oct 2011
Accuray Receives 510(k) Clearance for a Rotational Dose Control for the TomoTherapy System
Devices Oncology FDA

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

HSMN NewsFeed - 24 Oct 2011
FDA Approves ONFI(TM) (clobazam) for the Adjunctive Treatment of Seizures Associated with Lennox-Gastaut Syndrome in Patients Two Years and Older
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 19 Oct 2011
Safety to the Power of Three: B. Braun Medical Inc. Announces Introcan Safety(R) 3 Closed IV Catheter
Devices FDA

HSMN NewsFeed - 19 Oct 2011
Crospon receives FDA clearance for External Channel endoscopic accessory
Devices Gastroenterology FDA

HSMN NewsFeed - 18 Oct 2011
Spineology Receives FDA Clearance for Rampart(TM) Interbody Fusion System
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 17 Oct 2011
New Stent Provides Relief to Patients with Advanced Small Intestine Cancer
Devices Gastroenterology FDA

HSMN NewsFeed - 17 Oct 2011
Medtronic Announces 510(k) Clearance for the Aquamantys(R)3 System with Combined Hemostatic Sealing and Cutting Functionality
Devices FDA

HSMN NewsFeed - 14 Oct 2011
PLC Systems Receives FDA Approval to Commence Pivotal Study of RenalGuard in the U.S.
Devices FDA

HSMN NewsFeed - 12 Oct 2011
CorMatrix Receives Carotid Artery Repair Indication for its CorMatrix(R) ECM(R)
Devices FDA

HSMN NewsFeed - 10 Oct 2011
FDA Approves Combivent(R) Respimat(R) (ipratropium bromide and albuterol) Inhalation Spray for the Treatment of Patients with Chronic Obstructive Pulmonary Disease
Biopharmaceuticals FDA

HSMN NewsFeed - 7 Oct 2011
Cialis(R) for Once Daily Use Now FDA-Approved to Treat Men With Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) and Men With Both Erectile Dysfunction (ED) and Signs and Symptoms of BPH
Biopharmaceuticals FDA

HSMN NewsFeed - 3 Oct 2011
Siemens Mobilett Mira Mobile Digital X-Ray System Receives FDA Clearance
Devices Radiology FDA

HSMN NewsFeed - 2 Oct 2011
Nucletron, an Elekta Company, Receives FDA 510(k) Clearance for Precise Vaginal CT/MR Multi Channel Applicator
Devices Oncology FDA

HSMN NewsFeed - 29 Sep 2011
CorMedix Announces FDA Designation for Neutrolin (CRMD003)
Biopharmaceuticals

HSMN NewsFeed - 28 Sep 2011
TandemHeart Cleared for Use with Oxygenator
Devices Cardiology FDA

HSMN NewsFeed - 26 Sep 2011
Smiths Medical Receives 510(k) U.S. FDA Clearance for Wireless Version of the Medfusion(R) 4000 Syringe Infusion System
Devices Drug Delivery FDA

HSMN NewsFeed - 26 Sep 2011
Zynex Receives FDA 510(k) Clearance for the NexWave Medical Device
Devices Neurology FDA

HSMN NewsFeed - 20 Sep 2011
Anulex Technologies, Inc. Announces FDA Clearance of the fiXate(TM) Tissue Band
Devices Neurology FDA

HSMN NewsFeed - 20 Sep 2011
Mylan's Matrix Receives Tentative FDA Approval Through PEPFAR for Novel "Co-Packaged" Version of HIV/AIDS Treatment
Biopharmaceuticals HIV/AIDS FDA

HSMN NewsFeed - 19 Sep 2011
FDA Approves New Indications for Prolia(R) (Denosumab) for the Treatment of Bone Loss in Patients With Prostate or Breast Cancer Undergoing Hormone Ablation Therapy
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 15 Sep 2011
Medtronic Announces 510(k) Clearance for the TSRH(R) Spinal System Pedicle Screw for the Treatment of Adolescent Idiopathic Scoliosis
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 14 Sep 2011
ApoPharma Announces FDA Advisory Committee Recommendation in Favor of Ferriprox(R) (deferiprone) Approval
Biopharmaceuticals FDA

HSMN NewsFeed - 14 Sep 2011
Zimmer Receives Pediatric Clearance for Universal Clamp Spinal Fixation System
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 13 Sep 2011
Advanced Bionics Announces FDA Approval for U.S. Market Re-Entry of the HiRes 90K Cochlear Implant
Devices FDA

HSMN NewsFeed - 12 Sep 2011
FDA Clears IsoRay's GliaSite(R) Treatment for Brain Cancer
Devices Oncology FDA

HSMN NewsFeed - 12 Sep 2011
Genentech Submits New Drug Application to FDA for Vismodegib for Rare Form of Advanced Skin Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 10 Sep 2011
Boston Scientific Issues Statement Regarding FDA Advisory Committee Meeting on Surgical Mesh to Treat Pelvic Organ Prolapse and Stress Urinary Incontinence
Devices Urology Surgery FDA

HSMN NewsFeed - 9 Sep 2011
Mylan Receives Approval for Promethazine Hydrochloride Tablets, USP
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 8 Sep 2011
FDA Grants Fluke Biomedical 510(k) Clearance for New ProSim(TM) Vital Signs Simulators
Devices Monitoring FDA

HSMN NewsFeed - 8 Sep 2011
FDA Advisory Committee Recommends Approval of Oral Anticoagulant Rivaroxaban for the Prevention of Stroke and Systemic Embolism in Patients with Non-Valvular Atrial Fibrillation
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 8 Sep 2011
Nexera Medical, Inc. Announces That It Plans to Submit New Data to the U.S. Food and Drug Administration (FDA) to Amend Its Current 510k Medical Device Clearance to Include Certain Strains of Viruses
Devices

HSMN NewsFeed - 6 Sep 2011
ViroPharma's Buccolam(R) (Midazolam, Oromucosal Solution) Granted European Marketing Authorization for Treatment of Acute Seizures
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 6 Sep 2011
FDA Clears Next-Generation Biomarker Test to Determine Likelihood of Ovarian Cancer in Women Who Present with Adnexal Mass
Diagnostics Oncology FDA

HSMN NewsFeed - 6 Sep 2011
Oceana Therapeutics Announces U.S. Launch of Solesta(R), The Only Nonsurgical FDA Approved Treatment for Patients Who Fail Conservative Therapy for Fecal (Bowel) Incontinence
Devices

HSMN NewsFeed - 6 Sep 2011
DelMar Pharmaceuticals Receives FDA IND Approval to Begin Clinical Trials With A New Brain Cancer Treatment
Biopharmaceuticals Oncology FDA

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