US-based Preventice has obtained CE Mark from the European Commission for its BodyGuardian remote monitoring system for use in detecting and monitoring non-lethal cardiac arrhythmias for ambulatory patients. Preventice has developed the ...
Tags: Remote Monitoring System, Medicine
Advanced Biological Laboratories (ABL) has received CE Mark approval to market its patient monitoring application TherapyEdge in Europe. TherapyEdge helps to not only capture but also to integrate all patient data and particular decision ...
Tags: CE Mark, Monitoring Application
Ventripoint Diagnostics has obtained CE mark certification from European notified body Intertek Semko for its NRV application for the VMS-2DE heart analysis system. The NRV database can be used in conjunction with right heart analysis ...
Tags: Ventripoint, CE Mark, NRV Application
The European Union (EU) has granted CE mark certification to Medtronic's Sentrant Introducer Sheath for the endovascular repair of aortic aneurysms. Designed for use with the company's Endurant II AAA and Valiant Captivia Stent Graft ...
Tags: aortic aneurysms, Medtronic, Sentrant Introducer Sheath
The British Standards Institution (BSI) has granted ISO 13485:2003 certification to Cardium Therapeutics' Excellagen advanced wound care gel product. Excellagen, which is designed for application at only one-week intervals, is a fibrillar ...
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
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 ...
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
St Jude Medical has obtained CE mark for its ViewFlex Xtra Intracardiac Echocardiography (ICE) catheter for providing improved control and maneuverability while performing complex cardiac ablation procedures using radiofrequency. The ICE ...
Tags: St Jude Medical, CE mark, ViewFlex Xtra ICE
BG Medicine has obtained CE mark certification for its automated Galectin-3 blood test, designed for the management of chronic heart failure. The test will be made available through bioMerieux's VIDAS immunoassay, which consists of about ...
Tags: EU, CE Mark, BG Medicine, Medicine
The European Union has granted CE mark certification to Blue Medical Devices' non compliant, high pressure drug eluting balloon (DEB). The new Protege NC device incorporates medication added to non compliant PTCA balloon, designed to ...
Tags: drug eluting balloon, post-dilatate stents, Blue Medical
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