NLT Spine’s eSPIN and PROW FUSION™ Together Offer a Complete Lumbar Interbody Fusion Procedure. FDA clearance means the system is good to go.
Regulatory
Sorin’s Perceval™ S Bio Valve CE Indication Extended To Over 65’s
Sorin has announced CE Mark approval for extended indications of the Perceval™ S sutureless valve, expanding the market and, the company says, paving the way for adoption of Minimally Invasive Cardiac Surgery
FDA Clears Thoracic-Length Aptus HeliFX™ Aortic Securement System
EVAR specialist Aptus Endosystems, Inc., has received 510(k) clearance from the U.S. FDA for its thoracic-length HeliFX™ Aortic Securement System.
Pediatric Clearance Sees K2M’s MESA® & Rail 4D™ Spinal Systems Indicated For Adolescent Idiopathic Scoliosis
K2M focuses its efforts on developing devices to address complex spine disorders, so will be delighted to have gained an extended FDA clearance for its clever spinal rod system, which can now be used in adolescent idiopathic scoliosis.
South Korean Knee Prosthesis Gains FDA Clearance
South Korean manufactured Lospa Knee® System from Corentec features cruciate retaining and posterior stabilised knee within a single system
Precision Spine, Inc. Announces FDA Approval for Slimplicity® Solo Anterior Cervical Plate System
Precision Spine subsidiary Spinal USA, Inc., has received 510(k) clearance from the FDA for the Slimplicity® Solo Anterior Cervical Plate System, adding another important cervical product to its broad and expanding product portfolio.
Teleflex’s New Arrow®PICC System Aims At Zero Complication Catheter Placement
Teleflex says its Arrow® VPS replaces the need for confirmatory chest X-ray by using state-of-the-art, real-time intravascular Doppler, ECG and advanced algorithmic logic to notify the clinician that the central catheter tip has reached the optimal location.
FDA Clears Covidien’s LigaSure™ Small Jaw Sealer/Divider For ENT Use
Covidien has announced that it has received 510(k) clearance from the U.S. FDA for its LigaSure™ curved, small jaw, open sealer/divider surgical instrument to be used in ear, nose and throat (ENT) procedures.
FDA Approves AF Ablation Device, But Not Yet For Use As An AF Ablation Device
Estech’s breakthrough technology for the first time combines the benefits of a bipolar clamp with the flexibility of an endoscopically guided probe with the capability of creating linear lesions anywhere on a beating heart. It’s for investigational use in AF ablation treatment in U.S right now.
Preventice receives FDA clearance to market BodyGuardian Remote Monitoring System™
Preventice™, Inc., a leading developer of mobile health applications and remote monitoring systems, announced today that the U.S. FDA has given the company 510(k) clearance for its BodyGuardian Remote Monitoring System.
FDA Approves Abiomed’s Higher Flow Impella®
Abiomed Receives FDA 510(k) Clearance for New, Higher Flow Impella Percutaneous Heart Pump, With Peak Flows of 4L/min
UK Regulator Issues Further Device Alert For Riata, Focusing On Early Lead Failure
UK regulatory authority the MHRA is very keen to ensure that all pertinent information on the management of the potential for externalised ICD leads, reaches the appropriate medical professional, so has issued a follow up device alert with updated guidance.
Will EU Adopt FDA’s New Post Marketing Surveillance Approach?
No great surprises as FDA proposes four key areas in which it believes improvements will lead to more (and more meaningful) post-marketing surveillance feedback. It’s been issued for comment from stakeholders.
Nellix® EndoVascular Aneurysm Sealing System Gets CE Mark: Launch Next Year
Californian vascular device company Endologix, Inc., has gained CE Mark approval of the current version of its unique Nellix® EndoVascular Aneurysm Sealing System which involves filling the aneurysm sac with a bag full of a biostable polymer in patients with abdominal aortic aneurysms.
SinuSys Gains CE Mark for AerOs™ Sinus DiIation System And Noses Towards U.S Clearance
Sinus health company SinuSys Corporation, has announced that it has received CE Mark for its AerOs™ Sinus Dilation System. AerOs is designed to gently open the sinus ostia, thereby restoring natural sinus drainage and ventilation using a simple, two-step interventional approach.
LOQTEQ® Trauma Plating System Gets Initial 510(k). More To Follow
Trauma and biomaterials company aap Implantate AG. has announced that it has received 510(k) clearance from the U.S FDA for the small fragment plating line of its Loqteq® product family.