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 ...
Do you ever wonder how controversial ingredients end up in your food in the first place? For instance, why are energy drink companies allowed to add novel ingredients such as botanical extracts to their products? And why were companies ever ...
Tags: processed foods, Food Additives
US-based Medac Pharma has reported the US Food and Drug Administration (FDA) acceptance of a new drug application (NDA) for its lead product candidate, MPI-2505, a subcutaneous injectable methotrexate (MTX) in a ready-to-use injection ...
Teva Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for its supplemental new drug application (sNDA) for three-times-a-week COPAXONE 40mg/mL, a new dose of COPAXONE. COPAXONE (glatiramer acetate ...
Benvenue Medical, a medical device company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Kiva VCF treatment system for the reduction and treatment of spinal fractures. The FDA marketing clearance is ...
AtheroMed has obtained marketing approval from the US Food and Drug Administration (FDA) for its Phoenix atherectomy system for treating peripheral artery disease (PAD). Phoenix atherectomy system is a peripheral atherectomy catheter ...
Tags: FDA, pPAD, debulked material, Archimedes Screw
US-based Pressure Products has obtained the US Food and Drug Administration (FDA) approval for its SafeSept needle free transseptal guidewire for use with any introducer system when crossing the interatrial septum. SafeSept, which assists ...
Tags: FDA, Dr James McCready, Royal Sussex County, SafeSept
Medtronic, a medical device company, has obtained the US Food and Drug Administration (FDA) approval for its CoreValve self-expanding transcatheter system. The device is designed for severe aortic stenosis patients who are too ill or ...
Tags: medical device, Medtronic
Affymetrix, a manufacturer of DNA microarrays, has obtained marketing authorization from the US Food and Drug Administration (FDA) for its Affymetrix CytoScan Dx assay that can detect chromosomal variations which may be responsible for a ...
Tags: FDA Approval, Cytoscan DX Assay
US-based medical device company Varian Medical Systems has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its updated ProBeam proton therapy system. Using the ProBeam system, clinicians can deliver the dose ...
Tags: Varian Medical, IMPT, ProBeam system
Illumina has entered into an agreement with Amgen to develop and commercialize a multigene, NGS-based test as a companion diagnostic for Vectibix (panitumumab), a fully human anti-EGFR monoclonal antibody therapeutic for the treatment of ...
Tags: Amgen, FDA, CE, Illumina Oncology
If Google's latest project is successful, the finger prick test for blood sugar levels could eventually become a thing of the past for diabetics. Google X lab is developing a smart contact lens that can measure glucose levels in tears ...
Tags: Smart Contact Lens, Google
Brian Otis gingerly holds what looks like a typical contact lens on his index finger. Look closer. Sandwiched in this lens are two twinkling glitter-specks loaded with tens of thousands of miniaturized transistors. It's ringed with a ...
Tags: Consumer Electronics, Electronics
Radius Medical has announced the US Food and Drug Administration (FDA) approval and product introduction of its new Prodigy support catheter. The company has designed the Prodigy support catheter for providing back up support to the ...
Tags: Radius Medical, Medicine