Roche announced has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for the use of four additional specimen types with the cobas CT/NG v2.0 test to help physicians diagnose Chlamydia trachomatis (CT) and Neisseria ...
US-based TYRX has obtained an approval from the US Food and Drug Administration (FDA) for expanded indications in marketing the AIGISRx N antibacterial envelope for use with spinal cord neuromodulators. Recently, TYRX has also obtained an ...
Cochlear, a provider of implantable hearing solutions, has obtained an approval from the US Food and Drug Administration (FDA) for the Cochlear Baha 4 attract system for use in the US. The new Baha 4 attract system is a magnetic Baha bone ...
Under pressure from the FDA, 23andMe says it will stop selling health-related genetic test analysis until it has resolved its dispute with the federal regulatory agency. "We remain firmly committed to fulfilling our long-term mission to ...
US-based Sense4Baby has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its smartphone-based maternal/fetal monitoring system. The company has also obtained CE Mark approval from the European Commission for its ...
PrimeraDx, a molecular diagnostics company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its ICEPlex C. difficile assay kit and the ICEPlex system. The ICEPlex system is a multiplex real-time PCR system ...
NanoViricides has received results of detailed lab analysis studies from the initial non-GLP toxicology studies of intravenously administered FluCide. No overt adverse safety and toxicology effects were observed in this study of the ...
Biogen Idec announced that the US Food and Drug Administration (FDA) has extended its review of a marketing application for the long-lasting recombinant factor IX Fc fusion protein Alprolix for haemophilia B by three months. The company ...
Baxter International has filed an amended biologics license application (BLA) to the US Food and Drug Administration (FDA) to re-start the review process for approval of HyQvia facilitated subcutaneous infusion to treat adult patients with ...
The US Food and Drug Administration (FDA) has granted orphan drug status for Teva Pharmaceutical's Treanda injection through October 2015 for indolent B-cell non-Hodgkin lymphoma (iNHL) that has progressed during or within six months of ...
BioDelivery Sciences International (BSDI) announced that it engaged in a positive meeting with the US Food and Drug Administration (FDA) regarding the clinical development program for Clonidine topical gel that will allow the program to ...
Global Vision, the industry leader in the development of innovative proofreading technologies, today announced the immediate availability of ScanBook, a new high-speed booklet scanner designed for the medical device and pharmaceutical ...
Tags: New High-Speed Inspection Technology, Booklet Inspection
A faulty electronic component in some Philips HeartStart automated external defibrillators may prevent the device from delivering a needed shock to a person suffering a cardiac emergency, the FDA recently warned. The Dutch multinational's ...
Tags: Philips Defibrillator, FDA
More than a week after the FDA told 23andMe to stop marketing its Personal Genomic Service tests, the Mountain View, CA–based company says it is complying. "23andMe halted all marketing last week in accordance with the FDA’s ...
The US Food and Drug Administration (FDA) has granted orphan drug designation to Conatus Pharmaceuticals' drug candidate emricasan for the treatment of liver transplant patients with reestablished fibrosis to delay the progression to ...