UK-based Biofortuna has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its line of SSPGo HLA PCR kits, designed for transplantation genotyping and identification of genes that may be associated with various ...
Tags: Biofortuna, Medicine
ZetrOZ has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the marketing of its ultrasound pain management device sam, a wearable, long-duration, ultrasonic diathermy device for use in applying deep ...
Tags: Ultrasound Therapy Device, Medicine, FDA
Low-calorie sugars offer new way to solidify vegetable oils and gels Researchers at the City College of New York have reported the successful transformation of vegetables oils into a semi-solid form using low-calorie sugars as a ...
Tags: Low-calorie sugars, solidify vegetable oils and gels, semi-solid form
US-based XOMA Corporation (XOMA) has received Orphan Drug Designation from the US Food and Drug Administration (FDA) for its IL-1 beta modulating antibody 'gevokizumab' for the treatment of pyoderma gangrenosum (PG). Gevokizumab is a ...
Tags: Orphan Drug, Medicine
Biosense Webster has obtained an approval from the US Food and Drug Administration (FDA) for its Thermocool Smarttouch catheter that enables direct and real-time measurement of contact force during catheter ablation procedures for patients ...
Tags: FDA Approval, Biosense Webster
Anika Therapeutics (ANIK) has received marketing approval for MONOVISC from the US Food and Drug Administration (FDA) for the treatment of patients suffering from osteoarthritis (OA) of the knee. MONOVISC is a single injection supplement ...
Tags: FDA Approval, Anika
Bristol-Myers Squibb (BMS) has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for its investigational DCV Dual Regimen (daclatasvir and asunaprevir) for use as a combination therapy in the treatment ...
Tags: Bristol-Myers, Medicine
Salix Pharmaceuticals and Pharming Group have announced that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) Action Date to 16 July 2014 for the Biologics License Application (BLA) for the ...
Tags: Drug, Pharming Group
US-based biotechnology firm Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for a supplemental New Drug Application (sNDA) of its Kalydeco (ivacaftor) for the treatment of people with cystic ...
Tags: FDA Approval, Vertex, Kalydeco sNDA
Stryker has announced the global launch of its new Trevo XP ProVue retriever, which expands the ProVue retriever line with additional size and shape options for physicians. Stryker claims that the Trevo ProVue retrievers are the ...
Admedus has obtained the US Food and Drug Administration (FDA) clearance to market an advanced cardiovascular scaffold, CardioCel, which is designed to repair and treat a range of cardiovascular and vascular defects. The approval is ...
Tags: Cardiocel, FDA Clearance
US-based AliveCor has obtained the US Food and Drug Administration (FDA) approval to sell its AliveCor heart monitor without prescription, previously available by prescription only. It is claimed to be the only FDA cleared mobile ECG ...
Tags: Heart Monitor, AliveCor
BrainStorm Cell Therapeutics has received a notice of allowance from the US Patent Office for its ‘Mesenchymal Stem Cells for the Treatment of CNS Diseases’ (serial number 12/994,761) patent application. This patent relates to ...
Tags: Cell Technology Patent, Medicine
German biotechnology company Miltenyi Biotec has received the US Food and Drug Administration's(FDA)approval for its CliniMACS CD34 reagent system to prevent graft-versus-host disease(GVHD)in the treatment of acute myeloid leukemia(AML). ...
Tags: Miltenyi Biotec, Blood, Medicine
The Gagnon Cardiovascular Institute at Morristown Medical Center became the first hospital in the tri-state area to adopt a new minimally invasive medical device to treat patients with severe aortic stenosis who are too ill or frail to ...