In vitro diagnostic company Venaxis has filed for CE mark approval of blood-based appendicitis test, APPY1, in Europe. The company expects to receive CE Mark by the end of 2012 and anticipates initiating commercialization in first quarter ...
Tags: appendicitis test, blood based appendicitis test, FDA, Venaxis
Surefire Medical, a developer of infusion systems, has received CE mark approval for its new Surefire infusion system, designed for use in chemo and radioembolization procedures. The CE mark approval is based on a recent retrospective ...
Tags: CE mark, infusion system, Surefire
St Jude Medical has received CE mark approval for its Portico Transcatheter aortic heart valve which is designed to treat patients with severe aortic stenosis who are at intermediate risk for undergoing open-heart surgery. The 23 mm ...
Tags: CE mark, aortic heart valve, medical device, Medical equipment
Boston Scientific has obtained CE mark approval for its Synergy Everolimus-Eluting platinum chromium coronary stent system, designed to improve post-implant vessel healing. The coronary stent, which features a combination of ...
Boston Scientific has completed enrolling first patient in REPRISE II clinical trial, designed to assess the safety and efficacy of the Lotus Valve system in minimizing aortic regurgitation (leaking). The Lotus Valve system, which the ...
Tags: Boston Scientific, first patient, REPRISE II clinical trial
ETView Medical has obtained CE mark approval for its VivaSight-DL airway management system. Single-use, disposable VivaSight-DL system comprises of a dual lumen airway ventilation tube with an integrated, continuous high-resolution video ...
Philosys, a contract design, development and manufacturing company, has obtained CE mark approval for its new Gmate SMART blood glucose monitor. By using the operating system of the smart phone, the patent pending technology of the Gmate ...
Tags: Philosys, Gmate SMART blood glucose monitor, Gmate SMART
Medtronic has introduced the Endurant II AAA Stent Graft system in the US, following the US Food and Drug Administration's (FDA) approval. The Endurant II AAA Stent Graft system is designed for the treatment of abdominal aortic aneurysms ...
Tags: Medtronic, Endurant II AAA Stent Graft system, FDA, EVAR
CardioKinetix has started enrolling patients for its PARACHUTE III, a post-market safety surveillance trial, in Germany. The dual-arm, multi-center, open-label trial, which will enroll up to 100 ischemic heart failure patients, is ...
AirXpanders has obtained CE mark approval for its needle-free, patient-controlled tissue expander, designed for patients undergoing breast reconstruction after a mastectomy. The new technology, AeroForm, incorporates new capabilities ...
Tags: AirXpanders, AeroForm, mastectomy
Global healthcare firm Abbott's everolimus eluting coronary stent system has been accorded with CE Mark in Europe. The XIENCE Xpedition everolimus eluting coronary stent system, which is used to treat coronary artery disease, provides ...
Tags: Abbott, CE mark, coronary stent system, coronary artery disease
Maquet Cardiovascular has obtained CE mark approval for its new Intergard Synergy antimicrobial vascular graft. The Intergard Synergy graft releases broad spectrum antimicrobial agents including silver acetate and triclosan from its ...
Tags: Maquet Cardiovascular, approval, antimicrobial vascular graft
Endosense has obtained CE mark approval for its TactiCath Quartz force-sensing ablation catheter for the treatment of atrial fibrillation and supraventricular tachycardia. The TactiCath Quartz includes a new force sensor that provides ...
Tags: Endosense, TactiCath Quartz
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