Covidien has announced FDA 510(k) clearance to market its Covidien Nellcor™ Bedside SpO2 Patient Monitoring System.
Approval/Clearance
CE Mark For Teleflex’s Newly Acquired Vascular Access Catheter
Teleflex Incorporated has announced that its Semprus BioSciences subsidiary has gained CE mark for its Nylus™ Peripherally Inserted Central Catheter with Semprus Sustain™ technology.
CE Mark For Boston Sci’s MRI Compatible Pacemakers
Boston Scientific Corporation has received CE Mark approval for use of its MRI compatible INGENIO™ and ADVANTIO™ pacemakers
510(k) Clearance For Medtronic’s Orthopaedic Bipolar Sealer with Cutting
Medtronic, Inc. has announced the FDA 510(k) clearance for its Aquamantys®3 BSC 9.1S Bipolar Sealer with Cutting, a new addition to the orthopaedic portfolio of the company’s Advanced Energy business. Combining sealing with cutting in a single device should make procedures more efficient, according to the company.
CE Mark For Sunshine Heart’s C-Pulse® Heart Assist System
Sunshine Heart, Inc. has received CE Mark approval for its C-Pulse Heart Assist System for the treatment of Class III and ambulatory Class IV heart failure.
Milestone Alert! First FDA Cleared Robot-Assisted PCI System
Vascular robotics company Corindus Vascular Robotics, has announced FDA 510(k) clearance has been granted for its CorPath 200 System to be used in percutaneous coronary interventions (PCI).
FDA Clearance For Siemens’ MAGNETOM Spectra 3T MRI System
Siemens Healthcare has announced that its MAGNETOM Spectra 3 Tesla MRI system has received US FDA clearance. The company believes it has achieved the optimal blend of reduced ownership costs, excellent image quality and rapid scan times with this system which it says provides hospitals and radiological institutes with easier access to 3T technology.
CE Mark For Lazarus Effect Funnel™ Guide Catheter
Nice product, well done for the CE Mark, but should Lazarus Effect be issuing a press release when it’s website’s not even finished? As medtech marketers we’re stumped why anyone would do that.
CE Mark For Blockade Medical™ Barricade Coil System™
Another in a long line of Californian medtech start-ups, Blockade Medical™ has announced the gaining of CE Mark status for its Barricade Coil System™, designed to remove or endovascularly occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Brazilian Approval For Covidien’s Solitaire FR Revascularization Device
There’s no stopping Covidien’ s neurovascular clot retrieval device, which the company has announced can now add Brazil to Europe and USA as territories wher eit is approved for sale.
CE Mark For autoRIC™ Remote Ischemic Conditioning Device
Canadian company CellAegis Devices, Inc., has announced that it has received a CE Mark for its autoRIC™ Device, which the company says for the first time allows simple, consistent, reliable and cost-effective automation of remote ischemic conditioning at the point of care.
FDA Clears First Ever Bi-directionally Retrievable Vena Cava Filter From Crux Biomedical
Crux Biomedical has announced FDA clearance for its novel Vena Cava Filter which uniquely features bi-directional retrieval via either the femoral or jugular vein access.
Now Xlumena’s Axios Stent CE Mark Approval Includes Biliary Tract Drainage
Xlumena, Inc. has announced that it has received CE Mark approval to market its AXIOS Stent and Delivery System for biliary tract drainage. The device was previously approved for the treatment of pancreatic pseudocysts.
FDA Clears Expanded Size Range Of TriReme’s Glider™ PTCA Balloon Catheter
TriReme Medical, Inc. has announced that it has received FDA clearance for an expanded matrix of sizes for its unique Glider PTCA balloon catheter. Glider is now approved for the treatment of lesions in the coronary vasculature in balloon diameters from 1.5 3.5mm and in lengths from 4mm to 20mm.
FDA 510(k) Clearance For Olea Sphere Medical Imaging Software
Imaging specialist Olea Medical, has obtained FDA 510(k) clearance to market its Olea Sphere medical imaging enterprise software package in the US.
FDA Clears Kimberly Clark’s Kimguard One-Step Sterilisation Wrap Portfolio With One-Year Package Integrity
Kimberly-Clark Health Care has announced that it has received FDA 510(k) clearance for its KIMGUARD ONE-STEP portfolio with one-year maintenance of package integrity for KC300 to KC600 for Pre-vacuum Steam and Ethylene Oxide.