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
BioAlliance Pharma, an innovative Company dedicated to the development of orphan oncology, announced today that Validive (clonidine Lauriad) received a Fast Track designation from the US Food and Drug Administration (FDA) for the prevention ...
Tags: FDA, BioAlliance Pharma, disease, Validive
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
Hi-Tech Pharmacal Co., Inc. (NASDAQ:HITK), a specialty pharmaceuticals company, announced today that the US Food and Drug Administration, (FDA) granted final approval for the Company's Abbreviated New Drug Application, (ANDA) for Bromfenac ...
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
Global standards organisation GS1 has received accreditation by the US Food and Drug Administration (FDA) as issuing agency for unique device identifiers (UDI). Global GS1 Standards meet the government’s criteria for UDI and will ...
Tags: FDA Accreditation, GS1
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
Caffeine may help long-term memory Whether it's a mug full of coffee, a cup of hot tea, or a can of soft drink, consuming caffeine is the energy boost of choice for millions who want to wake up or stay up. But the popular stimulant could ...
Tags: Caffeine, long-term memory, memory enhancer
Argon Medical Devices, Inc. announced today that the company has received clearance from the US Food and Drug Administration to begin marketing the Option™ELITE retrievable inferior vena cava (IVC) filter with a new over-the-wire ...
Australia's proposed Health Star Rating System for food labelling New Zealand’s nutritional food labels are not as effective as once thought and could be impacting on the health of New Zealanders, according to new research from the ...
Tags: Health Star Rating System, food labelling, nutritional food labels
Headquartered in a traditional courtyard in downtown Beijing, Tongrentang (TRT), a pharmaceutical giant with a history of more than 300 years, is increasing its international reach with its legacy products: traditional Chinese medicine ...
Tags: TCM Companies, Global Market
US-based pharmaceutical company Merck & Co has recalled Liptruzet products from wholesalers in the domestic market due to a defect in the product's packaging. The defective outer laminated foil pouches are liable to allow air and moisture ...
Integrity Applications and Ultramedix Australasia have signed an agreement for the distribution of Integrity Applications’ GlucoTrack non-invasive blood glucose measurement device in Australia and New Zealand. Subject to the ...