Elixir Medical has gained CE Mark approval for its DESyne BD Novolimus Eluting Coronary Stent System with biodegradable polymer coating. The Elixir DESyne BD stent leverages the technology that enables an ultrathin (< 3 microns) polymer ...
Tags: Elixir Medical, Elixir DESyne BD stent, biodegradable polymer coating
Endologix, a developer of cardiovascular devices, has obtained CE mark approval for its Nellix endovascular aneurysm sealing system. The system is designed to simplify endovascular procedures and to treat patients with abdominal aortic ...
Tags: Endologix, Nellix endovascular aneurysm sealing system
Boston Scientific has received the US Food and Drug Administration (FDA) approval for 32 mm and 38 mm lengths of the Promus Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent system. The Promus Element Stent is made with a ...
Tags: FDA, Boston Scientific, Promus Element Stent, coronary artery disease
Dexcom has obtained CE mark approval for its new Dexcom G4 continuous blood glucose monitoring system. The Dexcom G4 system is designed to help diabetes patients to better manage their diabetes and control their glucose levels. Dexcom ...
Tags: Dexcom, CE mark approval, G4 system, diabetes, glucose levels
Boston Scientific has entered into a definitive agreement to buy a developer of-gener nextation mapping and navigation systems, Rhythmia Medical. US based Rhythmia Medical's mapping and navigation technologies are used with catheter ...
Tags: mapping and navigation system, acquisition, clinical technology
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
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
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