BG Medicine's CardioSCORE test has received CE Mark, which enables the commercial sale of it in the EU and other countries that recognize the CE Mark. The CardioSCORE test is a patented diagnostic blood test designed to improve risk ...
Tags: BG Medicine, Cardioscore Test, blood test, Medicine
Cohera Medical has gained investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to commence the first no-drain clinical trial of its internal surgical adhesive. Designed for use during abdominoplasty ...
Tags: Cohera Medical, Cohera, Surgical Adhesive, surgeries
The US Food and Drug Administration (FDA) has granted approval to Actuated Medical's TubeClear system that clears patient feeding and decompression tubes. The CE-marked TubeClear system, which comprises of reusable control boxes and ...
Tags: FDA, TubeClear system, medical technology
CellAegis Devices has obtained Health Canada's investigational testing (ITA) approval to initiate a pilot clinical trial of its noninvasive autoRIC device for remote ischemic conditioning (RIC). The CE-marked device is placed around ...
Tags: Health Canada, ITA, clinical trial, RIC
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
W. L. Gore & Associates has won CE mark for the GORE hybrid vascular graft designed to expand treatment options for optimal outflow by maximizing the number of access sites available. The GORE hybrid vascular graft is indicated for ...
Bausch + Lomb and Technolas Perfect Vision have received 510(k) clearance from the US Food and Drug Administration (FDA)for Victus Femtosecond Laser platform, designed for use during cataract and corneal surgical procedures. The CE-marked ...
Tags: FDA, Victus platform, surgical procedures, platform
Blockade Medical has reported that the first patients have been treated with the Barricade Coil system to treat cerebral aneurysms. The Barricade Coil system, an embolization coil line, is designed to remove or endovascularly occlude ...
Tags: Blockade Medical, Barricade Coil system, cerebral aneurysms
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
BD Diagnostics and Diagenode have together launched Diagenode Respiratory FLU A/B assay in Europe. The CE-marked FLU A/B primers and probes kit, which is designed to run on the BD MAX system, provides customers with a fully automated ...
Tags: Diagenode Respiratory FLU A/B assay, BD Diagnostics, diagnostic system
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