Denmark-based Novo Nordisk has announced that the European Medicines Agency (EMA's) Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of the NovoRapid PumpCart in Europe. NovoRapid PumpCart is a 1.6ml ...
US-based BioMarin Pharmaceutical has announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) voted in favor of approval of Vimizim for the treatment of Morquio A ...
The RNS device receiced FDA approval via the PMA pathway. NeuroPace (Mountain View, CA) landed FDA PMA approval for its RNS Stimulator, a device that can detect and treat patients suffering from drug-resistant epilepsy. Seizures occur ...
Tags: RNS, FDA approval, PMA pathway, NeuroPace
Inovio Pharmaceuticals has announced that preclinical testing of a DNA synthetic vaccine for the virulent Middle East Respiratory Syndrome coronavirus (MERS) induced robust and durable immune responses, demonstrating the potential for a ...
Tags: DNA Vaccine, MERS Virus
Kinetic Concepts (KCI) has obtained the US Food and Drug Administration (FDA) approval for its next generation V.A.C.Via negative pressure wound therapy system. The V.A.C.Via therapy system is a single-patient-use, ultra-portable V.A.C. ...
Tags: Therapy System, Medicine
GlaxoSmithKline (GSK) and Amicus Therapeutics have announced that Amicus has received global rights for the global drug development, regulatory and commercial activities of migalastat HCl as a monotherapy and in combination with enzyme ...
Tags: GlaxoSmithKline, Fabry Agreement
AtriCure, a developer of solutions to treat atrial fibrillation (Afib), has announced the US Food and Drug Administration’s (FDA) approval to begin enrollment in a clinical study of its AtriClip left atrial appendage exclusion system. ...
Tags: AtriCure, Stroke Prevention
Biotronik, a manufacturer of cardiovascular medical devices, has obtained the US Food and Drug Administration (FDA) approval for Phase B of the company’s ongoing ProMRI clinical trial. Biotronik has recently completed Phase A of the ...
Tags: Promri Clinical Trial, Biotronik
US-based Boston Scientific has obtained CE Mark approval for its Vercise deep brain stimulation (DBS) system for the treatment of intractable primary and secondary dystonia. Dystonia is a neurological movement disorder characterized by ...
Tags: Dystonia Treatment, DBS System
The US Food and Drug Administration (FDA) has approved Janssen Therapeutics' NS3/4A protease inhibitor 'Olysio (simeprevir)' for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with ...
Myriad Genetics, a molecular diagnostic company, and biotechnology firm BioMarin Pharmaceutical have signed a research collaboration agreement for identifying tumor types that may be sensitive to BioMarin's investigational product ...
Tags: Myriad Genetics, Biomarin
Medtronic's Valiant 'Mona LSA' branch thoracic stent graft system demonstrated proof of concept in a first-in-human study being conducted under the US Food and Drug Administration (FDA)'s ‘Innovation Pathway’ early feasibility ...
Tags: stent graft system, Medicine
Big Rock Brewery Inc announces Cuvée Bru, its newest Alchemist Edition beer created by Brewmaster Paul Gautreau and his team. In collaboration with Therapy Vineyards & Guesthouse located on the Naramata Bench, British Columbia, ...
Posted in Cardiovascular by Qmed Staff on November 19, 2013 The Sapien 3 could be used in a broader range of patients than earlier TAVR products introduced internationally. Edwards Lifesciences (Irvine, CA) is in the news after The ...
Today I'm ecstatic about being able to bring you exciting new holistic solutions for health, and today we've got something amazing for you in the realm of holistic dentistry and gum care: O3 Essentials (www.O3essentials.com) Over the past ...
Tags: Natural News, miracle, dentistry, gum, O3