Orthofix International N.V. announced that the Company has received CE Marking for its Advent™ Cervical Disc, allowing it to begin selling the new device in Europe.
CE Mark Approval
CardioFocus Receives CE Mark For Atrial Fibrillation Ablation Catheter
CardioFocus, Inc. announced that it has received a CE Mark allowing the company to commence European marketing of the Endoscopic Ablation System (EAS) to treat patients with atrial fibrillation.
Abbott Receives CE Mark For Company’s Next-Generation XIENCE PRIME™ Drug Eluting Stent
Abbott announced that it has received CE Mark for its next-generation XIENCE PRIME™ Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease.
CorNova® Receives CE Mark Approval For Valecor Platinum® Coronary Stent System
CorNova Inc. announced that it has received CE mark approval for its Valecor Platinum Coronary Stent System.
Medtronic Receives CE Mark for Second-Generation MRI Pacemaker
Medtronic, Inc. today announced it has received CE Mark for the company’s second-generation pacemaker designed, tested, approved for use as labeled with MRI machines, the Advisa DR MRI™ SureScan™ pacing system.
EarlySense’s EverOn™ System Receives FDA Clearance and CE Mark Certification
EarlySense announced today that its EverOn contact-free patient supervision system has been cleared for marketing by the U.S. Food and Drug Administration and has received a CE Mark certification from KEMA, a Dutch notified body.
CE Mark Extended for Disc Dynamics’ DASCOR Disc Arthroplasty System
Disc Dynamics, Inc. announced that the CE Mark received in the European Union for its DASCOR® Disc Arthroplasty System has been expanded to incorporate a posterior-lateral surgical approach, as well as an endoscopic approach.
Ingen Moves Toward $4 Billion Dollar Respiratory Market in Europe and Asia
Ingen Technologies, Inc. announced today agreements with Emergo Global Consulting LLC to prepare and register the ISO and CE mark certifications required to market and sell Oxyview in Europe, Asia and Canada.
Endeavor Drug-Eluting Stent is First to Receive CE Mark for Treating Acute Coronary Syndrome
Medtronic, Inc., today announced that its Endeavor drug-eluting stent (DES) is the first and only coronary stent to have received CE Mark approval for treating patients with acute coronary syndrome.
Invatec Receives CE Mark Approval for the IN.PACT Admiral Drug Eluting Balloon
Invatec, a comprehensive innovator of interventional products, today announced the receipt of the CE Mark and the European launch of its IN.PACT™ Admiral paclitaxel-eluting PTA balloon catheter at the EuroPCR Congress 2009 in Barcelona, Spain.
St. Jude Medical Announces European Approval of Accent RF and Anthem RF Pacemakers
St. Jude Medical, Inc. today announced European CE Mark approval of its Accent™ RF and Anthem™ RF CRT-P Pacemakers, equipped with wireless technology.
AxioMed Spine Corporation Receives CE Mark For Freedom Lumbar Disc
AxioMed® Spine Corporation announces the receipt of CE Mark approval for its Freedom® Lumbar Disc, an elastomeric total spinal disc replacement device.
St. Jude Medical Announces European Approval of Its Newest and Most Efficient Heart Failure Devices
St. Jude Medical, Inc. today announced European CE Mark approval of its Promote Accel™ implantable cardiac resynchronization therapy defibrillator (CRT-D).
Endosense Receives CE Mark for TactiCath Force-Sensing Ablation Catheter
Endosense, a medical technology company focused on enabling the broad adoption of catheter ablation for the treatment of cardiac arrhythmias, has announced that it has received the CE mark for its TactiCath system.
Amedica Receives CE Mark For Valeo™ Ceramic Spinal Implant System Incorporating CSC Technology
Amedica Corporation announced that it has received a CE mark for initial rollout of their spinal intervertebral spacers using novel CSC (cancellous-structured ceramic) technology.
St. Jude Medical Announces CE Mark Approval of Remote Care System for Implantable Cardiac Devices
St. Jude Medical, Inc. today announced European CE Mark approval of its Merlin.net™ Patient Care Network. Merlin.net PCN is a secure, Internet-based remote care system that gathers and stores data from the implant procedure, a clinic follow-up visit or from remote follow-up transmissions of patients with implanted cardiac devices.