InspireMD has received approval for its investigational device exemption (IDE) application from the US Food and Drug Administration (FDA) to initiate MASTER II clinical study of its MGuard embolic protection stent (EPS). The CE-marked ...
Tags: InspireMD, Protection Stent Study
MagForce has obtained German Federal Institute for Drugs and Medical Devices' (BfArM) approval for the start of a post-marketing clinical study in recurrent glioblastoma patients. The controlled, open-label and randomized study will ...
The Chinese State Food and Drug Administration (SFDA) has approved Symrise's SymWhite 377 as an ingredient for cosmetic applications. Thanks to the SFDA approval of SymWhite 377, Symrise now offers its successful and potent solution for ...
BioControl Medical has gained the US Food and Drug Administration approval to begin the third and largest phase of INOVATE-HF (INcrease Of VAgal TonE in Heart Failure), a global, multi-center, investigational device exemption (IDE) clinical ...
Tags: BioControl Medical, FDA, Medical
St. Jude Medical, a US-based provider of medical technologies, has presented positive results from RESPECT clinical study of its Amplatzer PFO occluder device. The double-disc transcatheter PFO closure device, which is comprised of ...
Medrio, a US-based integrated eClinical software manufacturer, is offering its web-based Electronic Data Capture (EDC) Software for Clinical Research to universities under its Medrio Scholars program. The firm claims that the EDC software ...
Tags: Medrio, free EDC Software, Clinical Research
Cohera Medical, a developer of absorbable surgical adhesives and sealants, has obtained regulatory approval to commence human clinical trials on its single-part synthetic surgical sealant in Europe. Designed as an adjunct to standard ...
Tags: Cohera Medical, absorbable surgical adhesives, sealants
Abbott has presented clinical study data from a Endovascular Valve Edge-to-Edge REpair STudy (EVEREST II ) High Surgical Risk cohort of its MitraClip System for the treatment of mitral regurgitation (MR). The CE-marked catheter-based ...
Tags: clinical study, MitraClip System, medical
St. Jude Medical has implanted the first patient in a clinical study of its Amplatzer Cardiac Plug (ACP) device, designed for the prevention of stroke in patients with non-valvular atrial fibrillation (AF). The self-expanding occlusion ...
Tags: St.Jude Medical, clinical study, ACP device
CircuLite has obtained conditional approval from the US Food and Drug Administration (FDA) for its Synergy Circulatory Support System, designed for reversing the symptoms of heart failure in ambulatory chronic heart failure patients. The ...
Tags: CircuLite, FDA Conditional Approval, Micro-Blood Pump Device
Cohera Medical has treated the first patient in a US no-drain clinical study of its TissuGlu Surgical Adhesive, designed for use during large flap surgeries such as abdominoplasty (tummy tuck). The CE-marked internal surgical adhesive ...
Tags: Cohera Medical, no-drain clinical study, TissuGlu Surgical Adhesive
Swedish medical device company Dignitana's subsidiary Brain Cool has announced that its medical brain cooling system is being tested in a Phase One clinical trial at the University of Edinburgh. The Brain Cool system, which uses a ...
The US Food and Drug Administration (FDA) has accepted Biogen Idec's biologics license application (BLA) for the marketing approval of recombinant factor IX Fc fusion protein (rFIXFc) for the treatment of hemophilia B. Using the company's ...
Tags: FDA, Idec BLA, hemophilia B
The US Food and Drug Administration (FDA) has approved Tenaxis Medical's ArterX Surgical Sealant, designed for use in vasculature reconstruction in various surgical procedures. ArterX Surgical Sealant is a two-part liquid system that will ...
US-based biopharmaceutical company Spring Bank Pharmaceuticals has closed a $10.5m Series A financing round from Brock Securities with Gilford Securities as a participator. The firm is planning to invest the fund in its Phase I clinical ...