GlaxoSmithKline (GSK) has announced the FDA approval of four-strain seasonal influenza (flu) virus vaccine, Fluarix Quadrivalent, to immunize adults and children of three years age and more, in the US. The intramuscular vaccine is ...
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Quidel's non-instrumented molecular diagnostic assay, designed for the detection of toxigenic Clostridium difficile (C difficile) bacterial DNA. The AmpliVue C. ...
Tags: FDA, Non-Instrumented C Difficile Detection Assay, medical technology
Abbott has received US Food and Drug Administration clearance for its new testosterone test, ARCHITECT 2nd generation testosterone assay. The testosterone assay is expected to help physicians to accurately measure the wide range of ...
Tags: FDA, testosterone test, clinical technology
Teleflex has received FDA 510(k) clearance to market its pressure injectable ARROW PICC preloaded with the ARROW VPS Vascular Positioning System Stylet. The preloaded ARROW PICC enables clinicians to save the time and process of ...
Tags: FDA, Teleflex, medical system
US-based True Taste is recalling seafood products as they may have the potential to be contaminated with Clostridium botulinum,a bacterium which can cause life-threatening illness or death. The products being recalled are vacuum packaged ...
Tags: seafood products, True Taste, Hot Smoked Products, Clostridium botulinum
GlaxoSmithKline (GSK) has announced FDA approval of raxibacumab anti-toxin as a combination therapy along with antibacterial drugs for the treatment of inhalational anthrax in both adult and pediatric patients with limited treatment ...
The USFDA has approved Novartis' Signifor (pasireotide) injection to treat Cushing's disease, an endocrine disorder. The only approved pituitary-directed therapy in the US, for the patients who are not suitable for pituitary surgery, ...
Tags: USFDA, Cushing's disease, clinical treatment
Syneron Medical has received the US Food and Drug Administration (FDA) approval for its new elos Plus multi-platform device. The new elos Plus device utilizes the company's proprietary elos technology of optical energy and bi-polar ...
Tags: FDA, elos Plus multi-platform device, medical technology
US-based Clearly Clean Products has introduced its new recyclable modified atmosphere package (MAP) tray for meat, poultry, entrées and kebobs. Simple for the processors to seal and easy for consumers to use, the FDA-compliant tray ...
The US Food and Drug Administration (FDA) has cleared Dexcom's new continuous glucose monitoring (CGM) system. The G4 PLATINUM system comprises a tiny sensor which is inserted by the user under the skin on the abdomen and a transmitter ...
Tags: Dexcom, continuous glucose monitoring system, G4 PLATINUM system
The Food and Drug Administration (FDA) Ophthalmic Devices Advisory Panel has scheduled to review the data presented in the Second Sight Medical Products' humanitarian device exemption (HDE) market approval application, for its Argus II ...
Tags: FDA, Argus II System, medical technology
C R. Bard has entered into a definitive agreement to purchase Neomend, a developer of sprayable surgical sealants and anti-adhesion products, for $140m. Neomend commercial products include FDA-approved Progel Air Leak Sealant, ...
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Teleflex Incorporated's new line of Weck reusable obturators, designed for use during laparoscopic procedures. The stainless steel obturators, which are ...
Tags: FDA, laparoscopic procedure, medical tool, medical technology
Uroplasty has reported positive results from subcutaneous tibial nerve stimulator's nine-year follow-up study. The FDA-approved stimulator, Urgent PC neuromodulation system, is a minimally invasive device used for treating overactive ...
Tags: Uroplasty, Urgent PC neuromodulation system, minimally invasive device
The US Food and Drug Administration (FDA) has cleared Respiratory Motion's ExSpiron respiratory monitoring system, designed for monitoring breathing abnormalities often associated with potentially lethal respiratory depression. ...
Tags: FDA, respiratory monitoring system, clinical technology