Smith & Nephew plc has followed last year’s launch of PICO in Europe, Canada, and Australia by announcing that its pocket-sized PICO single use Negative Pressure Wound Therapy (NPWT) system has now received FDA clearance.
Approval/Clearance
CE Mark For Biomerix ASSURE Soft Tissue Repair Mesh
California-based Biomerix Corporation has announced that it has received CE Mark approval for its ASSURE soft tissue repair mesh.
CE Mark For Airstrip Mobile Patient Monitoring Applications
Texas based AirStrip Technologies, Inc. has received CE Mark certification to market its innovative mobile patient monitoring applications in the European Community as well as other international territories outside Europe.
FDA Likes “Chocolate”… PTA Balloon Catheter
TriReme Medical, Inc.has received 510(K) FDA approval to market its “Chocolate” PTA balloon catheter for the treatment of occluded peripheral arteries in the United States.
Bioptigen’s Ophthalmic Imaging System Gains CE Mark
US ophthalmologic imaging technology company Bioptigen Inc., has received regulatory approval to market its hand-held Envisu C2000-series systems for clinical use within the European Union
Covidien Announces CE Mark for Nellcor™ Respiration Rate Software
Covidien extends the functionality of its Nellcor respiratory monitoring platform with CE Mark approval for its Nellcor™ Respiration Rate Version 1.0 Software and the Adult Respiration Rate Sensor.
CE Mark For SonoSite’s New Edge Ultrasound System
SonoSite, Inc.has received CE Mark approval to market its next generation point-of-care product: EDGE™ ultrasound system in the European Union.
FDA Approves AtriCure’s Synergy Ablation System For Atrial Fibrillation Treatment
First and Only System in the United States Approved to Treat Patients with Persistent and Long-Standing Persistent Atrial Fibrillation
CE Mark For Robotic Catheter Guidance Control and Imaging™System .
California-based Magnetecs Corporation has reported that the company’s Robotic Catheter Guidance Control and Imaging™ (CGCI) System has received CE Marking certification.
Infrascan Gains FDA Approval For Its Hand-Held Intracranial Haematoma Detection Device.
FDA permits marketing of Infrascanner 1000, the first hand-held device to aid in the detection of intracranial haematoma.
da Vinci Single Site Lap Chole System Gains FDA Approval
Intuitive Surgical, Inc. the global leader in minimally invasive robotic-assisted surgery, has announced that it has received FDA clearance to market its Single-Site Instrumentation for laparoscopic cholecystectomy procedures.
FDA Approves DePuy’s AOX ™Antioxidant Polyethylene Bearing
DePuy Orthopaedics, Inc.has received FDA Premarket Approval to use its AOX ™ Antioxidant Polyethylene material with the company’s SIGMA ® Rotating Platform Knee System and LCS ® COMPLETE ® Mobile Bearing Knee System.
iPhone Glucose Meter Now Gains FDA Approval
Sanofi’s iBGStar™ , already available in Germany, France, Switzerland, the Netherlands and Italy has now gained FDA 510(k) premarket clearance in USA.
Two New Products From Boston Scientific
Boston Scientific launchea CHARGER™ PTA Balloon catheter in USA and Infinion 16, first and only 16-contact percutaneous lead for treatment of patients suffering chronic pain.
CE Mark Approval for Bausch & Lomb Victus Femtosecond Laser
First Single-Platform Femtosecond Laser Now Commercially Available in European Union
CE Mark For Sorin’s New Oxygenator
Sorin Group has received CE Mark approval for INSPIRE™6, the first model of an entire new family of oxygenator systems bringing improved performance and flexibility during cardiopulmonary bypass procedures in adult patients.