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
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
Quidel has received FDA 510(k) clearance for its Quidel Molecular Influenza A+B assay for the detection of influenza A and B for use with Cepheid's SmartCycler PCR system. Quidel received FDA clearance in December 2011 to run its Quidel ...
Tags: Quidel, FDA 510(k)clearance, Quidel Molecular Influenza A+B assay
Saladax Biomedical has received CE mark for its MyPaclitaxel and MyDocetaxel therapeutic dose management (TDM) MyCare assays, enabling commercialisation in the European Union (EU). Both paclitaxel and docetaxel are administered based on a ...
Tags: Saladax Biomedical, Saladax's MyCare technology platform, MyCare tests
The European Union has granted CE mark to W.L.Gore&Associates'endovascular stent-graft with a new 35 mm trunk-ipsilateral leg and 36 mm aortic extender. Inserted through a catheter-based delivery technique,the GORE EXCLUDER AAA ...
Tags: GORE, European Union, CE mark, aortic business
Ortho Clinical Diagnostics' Vitros Immunodiagnostic Product 25-OH Vitamin D Total assay has received CE mark approval. The Vitros 25-OH Vitamin D Total assay is a new diagnostic blood test designed to measure levels of vitamin D2 and ...
Merck Serono, a division of Merck, and Auxogyn have partnered to develop Early Embryo Viability Assessment (Eeva) test. Pursuant to the deal, Merck Serono will provide strategic, scientific and medical support for the development of ...
Tags: Early Embryo Viability Assessment test, eeva test, clinical development
W. L. Gore & Associates has received CE mark approval for new diameter sizes of Gore Excluder AAA Endoprosthesis endovascular stent-graft, designed as a treatment for abdominal aortic aneurysm (AAA). The new diameter sizes of the Gore ...
Medtronic has obtained CE mark approval for its Shilla Growth Guidance system to provide new option for children with life-threatening curvature of spine. The Shilla system is designed to correct multi-planar spinal deformities associated ...
Tags: Medtronic, Shilla Growth Guidance system, curvature of spine
Micro Interventional Devices has initiated first-in-man Sutureless Transapical Access and Closure study (STASIS) trial to demonstrate the efficacy of its transapical access device in providing hemostatic access to the left ventricle during ...
Tags: Micro Interventional Devices, man Sutureless, cardiac procedures
Neurotech, a developer of active implantable devices, has received CE mark approval for its ADNS-300 to treat refractory epilepsy. The surgically implanted ADNS-300 system operates as a pacemaker to produce stimulation towards the brain ...
Tags: active implantable devices, Neurotech, refractory epilepsy