Los Angeles-based NeuroSigma, a developer of early stage neuromodulation technologies, has won ISO 13485: 2003 certification. The certificate indicates that the company meets the quality standards to design, and manufacture its external ...
Tags: NeuroSigma, neuromodulation technologies, ISO certification, eTNS
Neusoft Positron Medical Systems, a joint venture between China's Neusoft and America's Positron has obtained two key certifications for its Attrius Positron Emission Tomography (PET) systems. The new certifications comprise CE mark ...
Tags: Neusoft Positron, PET, key certifications
Medtronic has treated the first US patient in a global, multicenter clinical trial, designed to compare the accuracy of its CoreValve system with surgical aortic valve replacement in treating patients with severe aortic stenosis and who are ...
Biotronik has reported that the first US patient has been implanted with its Lumax 740 dual-chamber implantable cardioverter defibrillator (ICD). Lumax 740 dual-chamber ICD features SMART detection, which discriminate between atrial and ...
Tags: Lumax 740 dual-chamber implantable cardioverter defibrillator
Boston Scientific, a provider of cardiovascular implants, has completed enrolling patients in its Prevail confirmatory study. The CE-marked self-expanding nitinol frame Watchman device, placed in the left atrial appendage (LAA) via the ...
Tags: Boston Scientific, cardiovascular implants, Prevail confirmatory study
Flexible Stenting Solutions has received CE mark approval for its FlexSten Iliac Self Expanding Stent system for the treatment of symptomatic atherosclerotic disease of the common and/or external iliac arteries. The FlexStent Iliac Stent ...
Tags: Flexible Stenting Solutions, FlexSten Iliac Self Expanding Stent system
CardioKinetix has obtained CE mark approval for its full size matrix of its percutaneous ventricular restoration device to treat patients with ischemic heart failure. The Parachute ventricular partitioning device uses a small catheter ...
Tags: CE Mark, heart failure, medical device
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
The European Union (EU) has granted CE mark to Boston Scientific's deep brain stimulator to treat Parkinson's disease. The Vercise deep brain stimulator, which includes multiple independent current control, uses electrical signals to ...
Tags: Parkinson, Vercise, deep brain stimulator, Wurzburg neurology department
Blockade Medical has obtained CE mark for its Barricade coil system, designed to remove or endovascularly occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. The Barricade coil system, which includes ...
Tags: Blockade Medical, Barricade coil system, platinum microcoils
CardioComm Solutions has signed a three year enterprise cloud services (ECS) agreement with SunGard Availability Services, a subsidiary of SunGard Data Systems. The ECS agreement will provide CardioComm with the systems infrastructure to ...
SinuSys has obtained CE mark for its AerOs Sinus Dilation system, designed to open the maxillary ostia (openings that connect a sinus to the nasal cavity) and treat painful chronic sinusitis. The low pressure, self-expanding AerOs device ...
Tags: SinuSys, AerOs System, sinus disease
ReCor Medical has presented six-month follow-up data of eight patients treated via renal denervation with the company's Paradise system. The CE-marked Paradise system for renal denervation is based on ultrasound, not radiofrequency, ...
Tags: ReCor Medical, renal denervation, resistant hypertension patients
Restoration Robotics, a provider of image-guided devices, has received CE mark for its minimally invasive ARTAS system. The ARTAS system, which utilizes physician controlled, computer assisted technology, is designed to enhance the ...
Tags: ARTAS system, image-guided devices, Restoration Robotics
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 ...