Flexible Stenting Solutions, Inc., a leading developer of next-generation flexible stents, announced today it has received CE Mark for its FlexStent™ Biliary Self Expanding Stent System.
Regulatory
Kensey Nash Announces IDE Submission For Cartilage Repair Device
Kensey Nash Corporation announced that it has submitted an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) to study the use of the Company’s unique biomaterials technology for treating articular cartilage defects of the knee.
Bone Medical Receives Positive FDA Feedback On CaPTHymone™
Bone Medical Limited announced that it has had discussions with FDA on the US regulatory process for CaPTHymone™, Bone’s oral Parathoid Hormone product.
Benvenue Medical Receives CE Mark Approval for Kiva VCF Treatment System
Benvenue Medical, Inc., a developer of minimally invasive solutions for spine repair, announced today that it has received CE Mark approval in Europe for the Kiva™ Vertebral Compression Fracture (VCF) Treatment System.
Small Bone Innovations Receives European Union CE Mark for Its PRECISE SD Distal Volar Radius Plating System
Extends SBi’s wrist management portfolio Addresses most common fracture treated by hand surgeons Geometry provides optimized fit for a broad range of anatomic variations
New Rules For Bone And Skin Products – Human Tissue Authority, UK
The HTA (Human Tissue Authority) is announcing new rules for bone and skin products to protect patients from diseases such as HIV, Hepatitis C and CJD. The HTA already regulates the use of tissue containing cells to treat patients.
CYPHER SELECT® Plus Sirolimus-eluting Coronary Stent Now Approved In The EU For Treatment Of Patients With Diabetes
The CYPHER SELECT®Plus Sirolimus-eluting Coronary Stent has received CE marking within the European Union for treatment of patients with diabetes, a complex and often difficult-to-treat patient population.
Edwards Lifesciences Receives CE Mark For New Transfemoral Transcatheter Valve Delivery System
Edwards Lifesciences Corporation announced today that it received CE Mark approval for European commercial sales of the new RetroFlex 3 transfemoral delivery system for the Edwards SAPIEN transcatheter heart valve.
St. Jude Medical Announces U.S. Approval of Industry’s First Connector System Designed to Simplify Implant Process for Cardiac Resynchronization Therapy Devices
New lead and cardiac resynchronization system design is expected to offer implanting physicians a simpler and quicker procedure and reduces the volume of the leads and device in the chest pocket for heart failure patients
Neovasc Receives CE Mark Approval for Peripatch™ Aegis Staple Line Reinforcement Product
Aegis Can Now Be Marketed for Use in European Union.
Neovasc Also Announces Senior Management Changes and Issues Options.
St. Jude Medical Announces European CE Mark Approval For Libra Deep Brain Stimulation Systems For Parkinson’s Disease
St. Jude Medical, Inc. announced European CE Mark approval of its Libra® and LibraXP™ deep brain stimulation systems for treating the symptoms of Parkinson’s disease, a neurological disorder that progressively diminishes a person’s control over his or her movements and speech.
Flexible Stenting Solutions, Inc. Receives CE Mark for New FlexStent™ Femoropopliteal Self Expanding Stent System
Flexible Stenting Solutions, Inc., a leading developer of next-generation flexible stents, announced today it has received CE Mark for its FlexStent™ Femoropopliteal Self Expanding Stent System.
Adhezion Biomedical Announces CE Mark Approval for Film-Forming Microbial Sealant Floraseal™
Adhezion Biomedical LLC announced today that it received European CE Mark (Conformité Européene) approval for FloraSeal, a film-forming, cyanoacrylate-based microbial sealant in a ready-to-use applicator.
Orthomimetics Secures CE Mark Approval for Chondromimetic
Orthomimetics Limited, the UK-Based Regenerative Medicine Company, has Received CE Mark Approval for Chondromimetic, its Flagship Product for the Repair of Articular Cartilage and Bone
AGA Medical Receives European CE Mark Approval for AMPLATZER® Cardiac Plug – Device will enable minimally-invasive transcatheter closure of cardiac structures
AGA Medical Corporation announced today that it received European CE Mark approval for its AMPLATZER® Cardiac Plug (ACP). The ACP provides an innovative, minimally invasive solution for closing cardiac structures not involving the septal wall.
Live Total Knee Replacement Webcast
Live Total Knee Replacement Webcast Eases Patient Concerns