The European Union has granted CE mark approval to InSightec's transcranial focused ultrasound system for the treatment of essential tremor, tremor dominant Parkinson's disease and neuropathic pain. The non-invasive ExAblate Neuro ...
Tags: transcranial focused ultrasound system, Parkinson's disease
TranS1 has obtained CE mark approval for its VEO minimally invasive lateral access fusion system for interbody fusions. The VEO lateral fusion system, featuring two-stage retraction method that focuses on nerve visualization and then ...
Tags: TranS1, VEO lateral fusion system, lateral interbody implants
IntelligentMDx has received CE mark approval for its automated molecular HSV-1/2 test, designed for the Abbott m2000 system. The HSV-1/2 for Abbott m2000 assay detects Herpes Simplex Virus (HSV) viral DNA and differentiates HSV-1 and ...
Tags: IntelligentMDx, HSV-1/2 test, Abbott m2000 system, HSV
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
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 ...
Tags: Praena test, LifeCodexx, Sequenom
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
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
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
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
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 ...
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
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
Boston Scientific has obtained the CE mark approval for the extended longevity provided by its INCEPTA, ENERGEN, PUNCTUA, COGNIS and TELIGEN implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators ...
Smiths Medical has obtained CE mark approval for its passive safety device, designed to help protect clinicians and healthcare workers from unintended needlesticks injuries. The passive device, Jelco IntuitIV Safety IV catheter, features ...