Health News
The U.S. Food and Drug Administration has cleared for marketing a new safety engineered short-term peripheral Intra-Venous (IV) Catheter. The product, VantageCath, is designed to significantly reduce exposure to bloodborne pathogens during the placement of the catheter and also provide the clinician with desirable feature sets.
Existing safety engineered peripheral IVs have mechanisms to protect the [...]
Continue reading " Advantage Medical Devices Receives FDA Clearance for VantageCath "
Medtronic, Inc. (NYSE: MDT) today announced that the FDA has cleared the OneTouch UltraLink Meter as the new wireless meter exclusively certified by Medtronic to wirelessly communicate with Medtronic diabetes management products in the United States. This new meter uses Medtronic-certified wireless technology to transmit glucose readings directly to MiniMed Paradigm insulin pumps and the [...]
Continue reading " Medtronic Announces FDA Clearance of New OneTouch UltraLink Blood Glucose Meter "
DynaMed Systems, LLC announced today that the U.S. Food and Drug Administration (FDA) has approved its investigational Device Exemption (IDE) Application to study the Traxon Spinal Cord Repair Stimulation System (TRAXON System) in acute spinal cord injured patients. The study is designed to assess the safety and effectiveness of the TRAXON System, a surgically implanted [...]
Yulex Corporation, a company that produces natural rubber found to be safe for medical devices, received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the first medical device made from guayule, a desert crop native to the U.S. Southwest.
The examination gloves made with patented Yulex(R) natural rubber, and cleared by [...]
Continue reading " FDA Clears First Medical Product Made From Yulex Natural Rubber "
ARYx Therapeutics, Inc. (NASDAQ:ARYX) today announced that it has received clearance from the Food and Drug Administration (FDA) to initiate clinical testing of ATI-9242, a novel antipsychotic for the treatment of schizophrenia and other psychiatric disorders. The company has begun dosing healthy volunteers with ATI-9242 in a Phase 1 safety study being conducted under an [...]
Continue reading " Novel Antipsychotic Drug for Patients with Schizophrenia "
Alcon, Inc. (NYSE: ACL) announced today that the U.S. Food and Drug Administration (FDA) has approved PATANASE (olopatadine hydrochloride) nasal spray for the relief of the symptoms of seasonal allergic rhinitis in patients 12 years of age and older. PATANASE nasal spray, an extension to Alcon’s market-leading ocular allergy product line, will be available in [...]
Cephalon, Inc. (Nasdaq:CEPH) today announced that the U.S. Food and Drug Administration (FDA) has approved TREANDA (bendamustine hydrochloride) for Injection for the treatment of patients with chronic lymphocytic leukemia (CLL), a slowly progressing blood and bone marrow disease. The American Cancer Society estimates that more than 15,000 new cases of this rare disease will be [...]
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