Guideline to ecodesign for circulators available The Guideline on the application of Commission Regulation 641/2009/EC and the amendment 622/2012/EC with regard to ecodesign requirements for circulators is available on the Europump ...
Tags: Europump guideline, pump, pump industry
Cytori Therapeutics has expanded its Celution system's CE mark approval to include several new indications including cryptoglandular fistula. The Celution system, which pulls stem cells and other regenerative cells out of fat , provides ...
Tags: Cytori Therapeutics, cryptoglandular fistula, celution system
European Medicines Agency (EMA) has accepted to review Pfizer's marketing authorization application (MAA) for bazedoxifene/conjugated estrogens (BZA/CE). BZA/CE is designed for postmenopausal women with a uterus for the treatment of ...
Tags: bazedoxifene conjugated estrogens, BZA/CE, estrogen deficiency symptoms
Sequenom's European licensing partner LifeCodexx has launched its Praena test service in more than 70 prenatal clinics and hospitals in Germany, Austria, Liechtenstein and Switzerland following the CE mark approval. LifeCodexx CEO Michael ...
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True Diagnostics has gained CE-mark approval to distribute its TrueDX platform and quantitative thyroid-stimulating hormone (TSH) test in Europe. The TrueDX platform helps physicians to determine whether a patient suffers from a ...
Tags: TrueDX platform, thyroid-stimulating hormone test, TSH test
BG Medicine has filed 510(k) premarket notification for regulatory clearance of an expanded indication for its BGM Galectin-3 test with the FDA. The blood test is at present indicated for use in patients with chronic heart failure who are ...
Tags: BG Medicine, blood test, heart failure
The US Food and Drug Administration (FDA) has cleared Bausch + Lomb's enVista glistening-free, single-piece hydrophobic acrylic Intraocular Lens (IOL). enVista lens, developed by Advanced Vision Science (AVS), is designed to provide ...
Tags: FDA, Bausch+Lomb's, enVista lens
The US Food and Drug Administration (FDA) has granted 510(k) approval to Synergetics' VersaVIT vitrectomy system for use during performing retinal surgeries. Synergetics president and CEO David Hable said, "We believe that VersaVIT is ...
ADA Medikal has entered into an agreement to distribute BSD Medical's MicroThermX Microwave Ablation line of products in the Turkish market. The mobile MicroThermX system includes a microwave generator, single-patient-use disposable ...
Tags: mobile MicroThermX system, Turky distribution, clinical technology
Maquet Cardiovascular has gained US and European marketing rights for its new SENSATION PLUS 7.5Fr. 40Cc intra-aortic balloon (IAB) catheter, following the US Food and Drug Administration (FDA) and CE mark approvals respectively. The ...
Tags: marketing rights, catheter, FDA
Covidien will market its Nellcor bedside respiratory patient monitoring system in the US and European Economic Area (EEA), following the Food and Drug Administration and CE mark approvals. The new system, which can connect to the ...
Tags: respiratory monitoring system, FDA, clinical technology
The US Food and Drug Administration (FDA) has approved St Jude Medical's Amplatzer Vascular Plug 4. Amplatzer Plug is delivered using a standard diagnostic catheter and is designed for use in transcatheter embolization procedures ...
Tags: FDA, Amplatzer Vascular Plug 4, embolization
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Semprus BioSciences' vascular access catheter, designed to provide peripheral access to the central venous system. Using Semprus Sustain technology, the ...
Online Business Applications (OBA) has launched a lighter, web-based version of its Information Request Management System (IRMS) software, IRMS-CE. The new Web-based version is fully compatible with the company's legacy IRMS software, and ...
Quidel has gained CE mark for the Quidel Molecular Direct C difficile Tox A/B assay to detect toxigenic Clostridium difficile bacterial DNA. The Quidel Molecular Direct C difficile Tox A/B assay kits consist of an extraction-free, ...
Tags: Quidel, Quidel Molecular Direct C difficile Tox A/B assay kits, CE mark