NxStage Medical, Inc., has gained U.S. FDA clearance to market its System One™ to perform hemodialysis overnight while the patient is at home sleeping.
Regulatory
FDA Clearance and First U.S. Implant of Sorin’s Memo 3D ReChord Annuloplasty Ring
Sorin has gained U.S. FDA clearance for Memo 3D ReChord™, an innovative semi-rigid annuloplasty ring for mitral valve repair.
Bowel Glue Jumps Queue
Cohera Medical, Inc. has received Priority Review Status Designation from the US FDA for its Sylys® Surgical Sealant
FDA Nod for First 3D Stereoradiographic Planning Software For Hip Arthroplasty
French orthopaedic imaging specialist EOS imaging, tells us that the U.S. FDA has approved hipEOS, 3D hip arthroplasty planning software based on EOS stereo-radiographic 2D/3D imaging.
Medtronic Launches Chitosan-Based Nasal Packing and Stent for FESS
FDA cleared back in October, Medtronic is now to launch its Novashield, Chitosan-Based material for use in Functional Endoscopic Sinus Surgery.
Medtronic Touts FDA Approval and Launch of Two New CRT Quadripolar Leads
Newly FDA approved, additional Attain Performa® Quadripolar Leads deliver more options so physicians can optimize delivery of Cardiac Resynchronization Therapy
CE Mark for World’s Only MultiPoint Pacing Pacemaker
Quadra Allure MP™ CRT-P expands the St. Jude Medical heart failure portfolio and is supported by newly presented data that demonstrate an increase in patient response to multipoint pacing therapy
GORE® VIABAHN® Endoprosthesis CE Mark Extended to Include Arteriovenous Access
New CE approval extends to the revision of dialysis access vessels.
Aurora Spine Adds Canadian Approval for ZIP™ MIS Interspinous Fusion System
Aurora has added Health Canada to earlier FDA, CE and Australian TGA clearances.
FDA Clears CenterVue’s EIDON Fully-Automated Retinal Imaging System
New retinal scanning technology means “what was once a dream, is now a reality.”
FDA Clears ArtVentive EOS™ Vascular Occlusion Device
Vascular Occlusion just got a bit easier with the clearance of ArtVentive’s Endoluminal Occlusion Device.
Thoracic Insufficiency Syndrome Solution Upgraded from HDE to 510(k) Cleared
DePuy Synthes Spine’s VEPTR/VEPTR II Devices are the first spine devices to have such a change in regulatory status.
FDA Clears World’s First Injectable Wireless MicroSize Pain Relief System
Stimwave Technologies Inc., tells us it has received FDA clearance to market the world’s first wireless, microtechnology neuromodulation device for relief of chronic back and leg pain.
FDA Clears Aer-O-Scope™ 360° Colonoscope System
GI View Ltd., has announced that it has received U.S. FDA 510(k) clearance for its flagship product, the Aer-O-Scope™ Colonoscope System
FDA Clears Benvenue’s Luna® 360 Interbody Fusion System
Benvenue Medical has gained U.S. FDA 510(k) clearance for its Luna® 360 Interbody Fusion System for spinal fusion treatment of symptomatic degenerative disc disease
FDA Clears Supersonic Imagine’s New Musculoskeletal and Vascular Ultrasound Probes
It’s RSNA week, and SuperSonic Imagine is touting the FDA 510(k) clearance for two new probes used with its ultrasound machine, the Aixplorer®.