The European Union has granted CE mark to NeoChord's minimally invasive device, DS1000, that allows implantation of artificial chordae tendinae for the repair of mitral valve prolapse, via a transapical, off-pump procedure. In addition, ...
Tags: European Union, CE mark, NeoChord's minimally invasive device, Medicine
Accumetrics' VerifyNow II System has received CE marking for point-of-care measurement of platelet reactivity to antiplatelet agents. The receival of Ce mark is expected to expand the market opportunities for the VerifyNow System in both ...
Tags: Accumetrics, VerifyNow II System, CE marking, platelet reactivity
In vitro diagnostic company Venaxis has filed for CE mark approval of blood-based appendicitis test, APPY1, in Europe. The company expects to receive CE Mark by the end of 2012 and anticipates initiating commercialization in first quarter ...
Tags: appendicitis test, blood based appendicitis test, FDA, Venaxis
Flexible Stenting Solutions (FSS) has received CE Mark for 6 Fr Reconstrainable FlexStent self-expanding stent system and will now be able to market the stent delivery technology in the European Union. The new device, which integrates the ...
Tags: Flexible Stenting Solutions, stent system, stent delivery technology
Boston Scientific has implanted the first patient with a new version of its Ingevity pacing leads, designed for use in the magnetic resonance imaging (MRI) environment, in a clinical study. The pacing leads, which are expected be paired ...
Matrix Surgical has obtained CE mark and ISO 13485:2003 certification for its OMNIPORE High-density Porous Polyethylene craniofacial implants. The craniofacial implants, which are manufactured in the US, are designed for use in ...
Tags: CE Mark, ISO Certification, Surgical OMNIPORE Craniofacial Implants
Medpace has purchased MediTech Strategic Consultants, an European contract research organization which provides services to support medical device clinical trials. Under the acquisition, Medpace will add MediTech to its existing ...
Tags: acquisition, medical device clinical trials, expansion
Uroplasty has reported positive results from subcutaneous tibial nerve stimulator's nine-year follow-up study. The FDA-approved stimulator, Urgent PC neuromodulation system, is a minimally invasive device used for treating overactive ...
Tags: Uroplasty, Urgent PC neuromodulation system, minimally invasive device
SRS Medical, a provider of urology products, has purchased AbbeyMoor Medical's Spanner temporary prostatic stent. SRS Medical CEO Lee Brody said the Spanner is a synergistic addition to the company's suite of urology products for the ...
Tags: acquisition, urology product, clinical trial
The biotechnology and personalized medicine company, Epistem, has gained CE mark for its in vitro diagnostic medical device (CE-IVD), Genedrive Tuberculosis (TB) test. Epistem said the registration enables to place its TB test and ...
Tags: Epistem, CE mark, CE-IVD, diagnostic medical device, TB test
The European Union has granted CE mark to Hygieia's new diabetes insulin guidance system (DIGS), designed for insulin treated patients with poor glycemic control. The d-Nav system automatically updates insulin dosage as needed and ...
Tags: Hygieia, DIGS, CE mark, diabetes insulin guidance system, glycemic control
Surefire Medical, a developer of infusion systems, has received CE mark approval for its new Surefire infusion system, designed for use in chemo and radioembolization procedures. The CE mark approval is based on a recent retrospective ...
Tags: CE mark, infusion system, Surefire
St Jude Medical has received CE mark approval for its Portico Transcatheter aortic heart valve which is designed to treat patients with severe aortic stenosis who are at intermediate risk for undergoing open-heart surgery. The 23 mm ...
Tags: CE mark, aortic heart valve, medical device, Medical equipment
The European Union has granted CE mark to Abacus Diagnostica's molecular diagnostic assay, designed for detecting toxin-producing Clostridium difficile. The GenomEra C. difficile assay, which is designed for use with the company's ...
OncoSec Medical has obtained CE certification for its proprietary gene and drug delivery technology, designed to treat solid tumor cancers. The assessment and certification process was supervised by SGS Group, a provider of inspection, ...
Tags: OncoSec, CE certification, proprietary gene, drug delivery technology