The U.S. FDA has cleared new nitinol-based Phusion Metal™ Cervical Cage which aims to maximize bone growth through a fully interconnected porous structure, while matching the modulus of living cancellous bone.
Products
FDA Inks De Novo Approval for VasoPrep Surgical’s Surgical Marker Pen
VasoPrep Surgical tells us that the U.S. FDA has cleared its surgical marking pen under the agency’s de novo pathway
FDA Approves Medtronic Drug-Coated Balloon for Peripheral Artery Disease in Upper Leg
Medtronic has gained U.S. FDA approval for its IN.PACT Admiral drug-coated balloon for the interventional treatment of peripheral artery disease (PAD) in the upper leg.
FDA Clears First Home Nocturnal Hemodialysis
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.
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
Band-Aid with No Batteries Sends Temperature to Your Smartphone
What’s wrong with the old technology? Well, nothing, but this sounds like a winner and exemplifies wearable technology state of play
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.
Transcatheter Technologies Adds Transfemoral Approach to Trinity TAVI System
The German TAVI peddlers reckon Trinity’s a world beating “third generation” device. And now it can be delivered transfemorally.
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.