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
Pfizer and Ligand Pharmaceuticals have announced the FDA acceptance of bazedoxifene/conjugated estrogens (BZA/CE) new drug application (NDA) for review. The BZA/CE is an investigational therapy developed by Wyeth Pharmaceuticals to tackle ...
Tags: estrogens NDA, Pharmaceuticals, FDA, menopausal symptoms
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 ...
BioCardia has announced positive results from a Phase I/II trial of its Helical Infusion system, designed to deliver donor's (allogeneic) or treated patient's (autologous) adult mesenchymal stem cells (MSCs) via transendocardial stem cell ...
Tags: Helical Infusion system, stem cell injection, device, Infusion System
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 cleared Boston Scientific's subcutaneous implantable cardioverter defibrillator (S-ICD) to treat patients at risk for sudden cardiac arrest (SCA). The CE-marked system, which the company ...
Tags: FDA, CE-marked system, S-ICD system
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 ...
European ErP Directive (2009/125/EC) provides mandatory ecodesign requirements for all kind of energy related products. Just like LVD Directive and EMC Directive, products covered by ErP Directive shall bear CE marking when they are placed ...
In February 2012, TÜV SÜD is officially announced to be accredited by NVLAP for Energy Efficient Lighting Program. Under this accreditation, TÜV SÜD is recognized by Environmental Protection Agency (EPA) for the ENERGY ...
Tags: SüD, LED, lighting, NVLAP's, accreditation
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 ...
Moximed has implanted the first patient with its KineSpring system in a prospective, single-arm clinical US study. The study, named SOAR, will enroll 30 patien,,ts to evaluate the safety and efficacy of the medical spring system in the ...
Tags: Moximed, patient, KineSpring system
Ball Packaging Europe announced that its Wrexham can plant is fully functional again, as all its four production lines are up and running beginning second week of August 2012. Earlier, the plant had to stop production following a fire ...
Tags: Ball Packaging Europe, Wrexham, production