Australia-based Allied Healthcare Group has received CE mark approval for its lead regenerative product called CardioCel, which is used in treating congenital heart disease and repairing heart valves. The approval will help the company to ...
Tags: Cardiocel, CE Mark Approval
Reverse Medical has received the 510(k) clearance from the US Food and Drug Administration (FDA) for its MVP Micro Vascular Plug system, which is designed for peripheral artery embolization. MVP Micro Vascular Plug system is used to ...
Tags: Reverse Medical, Medicine
Sweden-based Episurf Medical has secured CE Mark approval for its Episealer Femoral Condyle, a personalized implant that helps in treating the damage in knee cartilage. The company obtained CE Mark after the product and its technical ...
Tags: Episurf Medical, CE Mark, Knee Implant
CryoLife, a US-based tissue processing and medical device company, has secured conditional US FDA approval of its Investigational Device Exemption (IDE) for PerClot. A hemostat made of absorbable polysaccharide granules, PerClot is ...
Tags: Cryolife, Trials of Perclot
Micell, a US-based biomedical company, has received CE (Conformité Européenne) Mark clearance for its MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES). MiStent Sirolimus Eluting Absorbable ...
Tags: Micell, Mistent SES
Integrity Applications, an Israel-based medical device company, has received CE Mark approval for its GlucoTrack DF-F non-invasive device. The GlucoTrack DF-F is a glucose measuring device that uses a patented combination of ultrasound, ...
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
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
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
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
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
Medical device manufacturer Life Care Medical Devices (LCMD) has obtained CE mark approval for its Keyhole Cup Laparoscopic Access Device. The device, unlike the previous procedures that involved inherent risk of injury to organs lying ...
Tags: Medical device, Medical, CE Mark
Theradiag has received a CE mark approval for its anti cyclic citrullinated peptide (anti-CCP) in vitro diagnostic (IVD) kit in rheumatoid arthritis. The test further expands the Fidis portfolio of diagnostic tests for auto-immunes ...
NuvoLase has obtained CE mark approval for its PinPointe FootLaser device, designed for treating nail fungus infection. The approval will allow the company to market the device and continue to serve its customers throughout the European ...