Medtronic has obtained CE mark certification from the European Union for its Attain Performa portfolio of quadripolar leads. The quadripolar leads are compatible with the company's Viva/Brava Quad cardiac resynchronization therapy ...
Tags: Medtronic, CE mark certification, Attain Performa portfolio
CircuLite has obtained conditional approval from the US Food and Drug Administration (FDA) for its Synergy Circulatory Support System, designed for reversing the symptoms of heart failure in ambulatory chronic heart failure patients. The ...
Tags: CircuLite, FDA Conditional Approval, Micro-Blood Pump Device
The British Standards Institute (BSI) has awarded ISO 13485: 2003 certification to Zyomyx's quality management system. Zyomyx is involved in developing and commercializing proprietary diagnostic platforms including quantitative disposable ...
Tags: Zyomyx, CD4 diagnostics, proprietary diagnostic platforms
Medtronic has gained CE mark approval for its Engager transcatheter aortic valve implantation (TAVI) system with transapical delivery catheter, from the European Union (EU). The new TAVI system, which is inserted in the apex (the lower, ...
Tags: Medtronic, transcatheter aortic valve implantation, TAVI
The European Union has granted CE mark approval to ALung Technologies' Hemolung Respiratory Assist System (RAS) for the treatment of patients with acute hypercapnic respiratory failure including acute respiratory distress syndrome and acute ...
Tags: ALung Technologies, Respiratory Assist System, minimally invasive device
The European Union has granted CE mark certification to NxStage Medical's NxStage System One for nocturnal home hemodialysis. Available in simplicity and revolutionary size, the portable hemodialysis system provides convenient use in ...
Germany-based Biotronik has obtained CE mark approval for its Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) series. The Ilesto 7 series, which the company claims to include the ...
Tags: ProMRI technology, DF4 connector, MR scans
The European Union has granted CE mark certification to ApiFix's minimally invasive treatment system for use in patients with Adolescent Idiopathic Scoliosis (AIS). Designed as an alternative to complex spinal surgeries, the ApiFix AIS ...
Tags: ApiFix, CE mark certification, AIS
US-based medical technology provider Boston Scientific said it is launching the new polymer-based drug-eluting stent (DES) system in the European market as the product has obtained CE mark approval. The Promus Premier everolimus-eluting ...
True Diagnostics has obtained CE mark for TrueDXPSA, a quantitative prostate specific hormone (PSA) test. TrueDXPSA test will enable doctors to rapidly determine the PSA level in a patient. True Diagnostics president and CEO Jerry Lee ...
Tags: Diagnostics, clinical studies, health
Makies have become the world's first 3D printed toys to feature the CE mark. This means the dolls, which can be designed and customised by users online before being transformed into a real product, are now CE-certified EN71-compliant ...
Tags: Makies, 3D printed toys, CE mark
Pittsburgh-based ALung Technologies has gained Health Canada approval for its Hemolung Respiratory Assist System (RAS), designed for treating patients with acute hypercapnic respiratory failure including acute respiratory distress syndrome ...
Tags: ALung respiratory dialysis device, minimally invasive device
St Jude Medical has treated the first patient with 25 mm Portico Transcatheter aortic heart valve using the transfemoral delivery system in its ongoing non-randomized, multi-center European trial. Made of bovine pericardial tissue, the 25 ...
Tags: Portico aortic heart valve, Medical, minimally invasive device
Direct Flow Medical has obtained CE mark approval for its transcatheter aortic heart valve system, which features double-ring design for creating a tight and durable seal around the annulus. The Direct Flow Medical transcatheter aortic ...
Tags: Direct Flow Medical, CE mark, Medical Care
The European Union has granted CE mark to Covidien's EverFlex self-expanding peripheral stent for use with Entrust delivery system. Entrust system, which the company claims to be the only one-handed delivery device on the market, features ...