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
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
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
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 ...
Boston Scientific has received CE mark approval for an expanded indication of Watchman Left Atrial Appendage (LAA) Closure device, designed to capture any clots that may form in the appendage. The Watchman device also reduces the risk of ...
Tags: CE mark approval, Watchman Device
EndoStim has received CE mark approval for its LES Stimulation system, designed to treat gastro-esophageal reflux disease (GERD) and eliminate the need for daily proton pump inhibitor (PPI) medication. By using low energy electrical ...
BG Medicine has obtained CE mark approval for its diagnostic blood assay, CardioSCORE, designed for identifying individuals who are at high risk for near-term major cardiovascular events including heart attack and stroke. The multivariate ...
Medical device company Nexstim in Finland,has obtained CE mark approval for its non-invasive Navigated Brain therapy(NBT)system. The system featuring MRI-based navigation allows users to visualize the electric field inside the patient's ...
Tags: medical device, Nexstim, NBT system, brain
Boston Scientific has obtained CE mark approval for its spinal cord stimulator(SCS)system with 32 contacts and 32 dedicated power sources. The Precision Spectra system,which has four lead ports offering more coverage of the spinal cord,is ...
Tags: Boston Scientific, CE mark approval, SCS system, spinal cord
The European Union has granted CE mark approval to BiO2 Medical's inferior vena cava(IVC)filter for use in critically ill patients who are at increased risk of pulmonary embolism and temporarily contraindicated for anticoagulation therapy. ...
Tags: European Union, CE mark approval, BiO2 Medical, IVC filter
Advanced Biological Laboratories (ABL) has received CE mark approval for its DeepChek and ViroScore Suite clinical genotyping solutions. The approval is based on several evaluations of the company's next generation sequencing (NGS) ...
Tags: Advanced Biological, ABL, CE mark approval, evaluations
Medtronic has obtained the CE mark approval for its Sentrino continuous glucose monitor (CGM), designed for use in hospital critical care units (CCU). Designed to optimize glucose management, the minimally invasive system displays ...
Tags: CGM, continuous glucose monitor, Medtronic, CCU