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.
Regulatory
Bone Solutions Inc. receives FDA 510(K) clearance for bone void filler, OsteoCrete
Bone Solutions Inc. announced today that it has received FDA 510(k) clearance for the first device in its technology pipeline—a proprietary bone void filler, OsteoCrete™.
Innovia LLC announced that it has received FDA 510(k) clearance to market the InnoPort™
Innovia LLC announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the InnoPort™ to facilitate single port access laparoscopy.
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.
FDA Approves SBi’s S.T.A.R. Total Ankle Replacement System
Small Bone Innovations, Inc., a leading provider of innovation, products, technology and education for the small bone & joint segment of the orthopedics industry, announced today that the FDA has approved SBi’s Scandinavian Total Ankle Replacement (S.T.A.R.®) system to treat U.S. patients.
FDA Clears Boston Scientific’s SpyScope® Access and Delivery Catheter
Boston Scientific Corporation today announced that it has received FDA 510(k) clearance to market its SpyScope® Access and Delivery Catheter for diagnostic and therapeutic applications in the pancreatico-biliary system.
FDA Approves Boston Scientific’s Next-Generation TAXUS® Liberte® Atom™ Stent System
Boston Scientific Corporation today announced it has received approval from the U.S. Food and Drug Administration to market its TAXUS® Liberte® Atom™ Paclitaxel-Eluting Coronary Stent System.
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.
FDA to Review Its Approval of Knee Device
The Food and Drug Administration said it will re-examine its decision to approve a knee-surgery device last December over the objections of several scientists and managers at the agency, according to a letter from the FDA that the Senate Finance Committee reviewed Monday.
St. Jude Medical Announces FDA Approval of Current Plus ICD and Promote Plus CRT-D Devices
St. Jude Medical, Inc. today announced U.S. Food and Drug Administration approval of the Promote® Plus cardiac resynchronization therapy defibrillator and Current® Plus implantable cardioverter defibrillators.
Edwards Lifesciences Receives FDA Approval for New Heart Valve
Edwards Lifesciences Corporation, the world leader in the science of heart valves, today announced that it has received approval from the U.S. Food and Drug Administration for the Carpentier-Edwards PERIMOUNT Magna Ease aortic valve, designed for easier implantation in the heart.
Gore Receives FDA Clearance For GORE BIO-A Fistula Plug
W. L. Gore & Associates announced that the US Food and Drug Administration has given the company 510(k) clearance to market the GORE BIO-A Fistula Plug, the next generation of anal fistula repair.