Auxogyn has obtained CE mark approval for its non-invasive early embryo viability assessment (Eeva) test, designed to improve in vitro fertilization (IVF) outcomes. By using intelligent computer vision software, Eeva test measures ...
EnteroMedics has reported subgroup analysis data from EMPOWER trial of its pacemaker-like device, designed to target the multiple digestive functions under control of the vagus nerves and to affect the perception of hunger and fullness. ...
Tags: EnteroMedics, VBLOC, Maestro system
Boston Scientific has received CE mark approval for an expanded indication of Watchman Left Atrial Appendage (LAA) Closure device, designed to capture any clots that may form in the appendage. The Watchman device also reduces the risk of ...
Tags: CE mark approval, Watchman Device
Avedro, a global ophthalmic medical device and pharmaceutical company, has expanded its portfolio of proprietary riboflavin formulations for corneal collagen cross-linking. The new formulations when used in conjunction with Avedro's ...
Healthcare products company Covidien has received Health Canada's approval for its revascularization device. The FDA-cleared and CE mark approved Solitaire FR device restores blood flow to the brain in patients with acute ischemic stroke, ...
Tags: FR revascularization device, Healthcare products, Treatment
The US Food and Drug Administration (FDA) has granted 510(k) approval to Avery Dennison Medical Solutions' new non-cytotoxic, grade 0 profile transparent wound film dressing, designed to treat catheter-related blood stream infections. ...
Tags: FDA, wound film dressing, clinical product, clinical application
ETView Medical has obtained European pre-market clearance for Viva-EB line of endobronchial blockers. The Viva-EB product family are designed to provide endobronchial blockade of the right or left lung for thoracic surgical procedures ...
Tags: Viva-EB line of endobronchial blockers, clinical application, CE Mark
EndoStim has received CE mark approval for its LES Stimulation system, designed to treat gastro-esophageal reflux disease (GERD) and eliminate the need for daily proton pump inhibitor (PPI) medication. By using low energy electrical ...
BG Medicine has obtained CE mark approval for its diagnostic blood assay, CardioSCORE, designed for identifying individuals who are at high risk for near-term major cardiovascular events including heart attack and stroke. The multivariate ...
The European Union has granted CE mark to Sequent Medical's VIA Microcatheter, which is available in VIA and the VIA PLUS models. The VIA Microcatheter is designed for the delivery and deployment of the company's low porosity ...
Tags: European Union, low porosity, neurovascular embolization device, health
European directive ErP(Energy related Products-2009/125/EC)defines a general legislative framework concerning the consumptions of"devices that consume energy"to which all manufacturers must conform. Thus manufacturers will have to ...
Tags: EU, energy efficiency, water pumps, manufacture
Medical device company Nexstim in Finland,has obtained CE mark approval for its non-invasive Navigated Brain therapy(NBT)system. The system featuring MRI-based navigation allows users to visualize the electric field inside the patient's ...
Tags: medical device, Nexstim, NBT system, brain
Boston Scientific has obtained CE mark approval for its spinal cord stimulator(SCS)system with 32 contacts and 32 dedicated power sources. The Precision Spectra system,which has four lead ports offering more coverage of the spinal cord,is ...
Tags: Boston Scientific, CE mark approval, SCS system, spinal cord
Guided Therapeutics has completed one of two major third-party electromagnetic compatibility testings of its non-invasive cervical scan device. Using the company's patented biophotonic technology, LuViva advanced cervical scan detects ...
IRIDEX has obtained FDA's 510(k) approval and CE mark for its non-invasive laser delivery system, designed for treating serious retinal diseases. Using MicroPulse technology, the new TxCell Scanning laser delivery system saves time in a ...
Tags: IRIDEX, non-invasive, laser delivery system, CE mark approvals