Cook Medical has received the 510(k) approval from the US Food and Drug Administration (FDA) for its Evolution Biliary Controlled-Release Uncovered Stent. Adding to the Cook's line of Evolution controlled-release stents for the ...
Tags: Cook Medical, Biliary Stent
Medtronic has received both the US Food and Drug Administration (FDA) approval and the CE (Conformité Européenne) Mark clearance for its Pacific Plus percutaneous transluminal angioplasty (PTA), the new peripheral balloon ...
Tags: Angioplasty Balloon, Medicine
Advanced Biological Laboratories (ABL) has received CE Mark approval to market its patient monitoring application TherapyEdge in Europe. TherapyEdge helps to not only capture but also to integrate all patient data and particular decision ...
Tags: CE Mark, Monitoring Application
Traumatic injury medical devices developer iTraumaCare has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its iTClamp Hemorrhage Control System. iTClamp is designed to control severe bleeding, in seconds, and ...
Tags: Itraumacare, FDA Approval
Boston Scientific has received CE Mark approval for use of the GUIDE DBS System, a deep brain stimulation (DBS) visual simulation system. GUIDE DBS offers clinicians with 3D visualization information that simulates stimulation output, ...
Tags: CE Mark, DBS System
US-based medical devices developer Elixir Medical has announced that the results of its CE Mark-approved DESyne BD Novolimus Eluting Coronary Stent System with biodegradable polymer coating were outstanding. Its CE Mark-approved DESyne BD ...
Direct Flow Medical, a developer of novel transcatheter heart valve technologies, has met its primary endpoint in the Discover CE Mark Trial by achieving 99% freedom from all-cause mortality at 30 days. The trial had enrolled 100 patients ...
Tags: Aortic Valve, Medicine
St. Jude Medical has received CE Mark approval for its Ilumien Optis Percutaneous Coronary Intervention (PCI) Optimization System. PCI, also known as coronary angioplasty, is a non-surgical procedure designed to provide disease assessment ...
Tags: St.Jude Medical, Medical
CircuLite has received an approval from the Federal Agency for Medicines and Health Products to begin the CE Mark trial of the Synergy IC Circulatory Support System (SICSS), which is designed for interventional cardiologist cannula ...
Tags: Circulite, CE Mark Trial
Reverse Medical has announced the CE Mark approval and initial clinical use of its MVP Micro Vascular Plug system for peripheral artery embolization. MVP Micro Vascular Plug system is used to obstruct or reduce the rate of flow of blood ...
Tags: Reverse Medical, Peripheral
Boston Scientific has received CE Mark approval for the Rhythmia Mapping System, a next-generation 3D mapping and navigation solution for use in cardiac catheter ablations and other electrophysiology (EP) procedures to treat abnormal heart ...
Tags: CE Mark, 3D Mapping System
Corgenix Medical has received the notification of CE Mark for its Relasv antigen rapid test for Lassa fever diagnosis. Relasv is the diagnostic test developed by Corgenix and members of the Viral Hemorrhagic Fever Consortium (VHFC), a ...
Tags: Corgenix Medical, Rapid Test
Abbott has received CE Mark for its Architect clinical chemistry Hemoglobin A1c (HbA1c) test, which may assist physicians in diagnosing and monitoring diabetes as well as identifying patients at risk for developing diabetes. The HbA1c ...
St. Jude Medical, a US-based medical device company, has announced CE Mark approval of its next-generation Ellipse and SJM Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy ...
Tags: St.Jude Medical, Mark
Cook Medical has obtained CE mark for PVA Foam Embolization Particles, designed for the treatment of symptomatic benign prostatic hyperplasia (BPH), also known as prostate enlargement. BPH can lead to lower urinary tract symptoms and is ...
Tags: Cook Medical, CE Mark, PVA Foam