US non-surgical obesity solutions company GI Dynamics, Inc. today announced that it has designated two new Centres of Excellence in Germany, bringing to three the number of specialist units offering the Endobarrier treatment in the country.
Regulatory
First Implant in St Jude Portico Transcatheter Aortic Heart Valve European Trial
St. Jude Medical, Inc. has announced the first implant of its Portico™ transcatheter aortic valve implant (TAVI) in a European clinical trial to support CE Mark approval.
Medical Device Alert: Molnlycke Health Care ProcedurePaks®
UK MHRA has issued a Medical Device Alert relating to Molnlycke Health Care ProcedurePaks® with devices containing latex, which have been labelled as latex-free.
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.
FDA Steps Up Publicity For Its “Preventing Surgical Fires” Initiative
The article outlines FDA’s recommended measures healthcare professionals could and should take to identify and avoid surgical fire risk.
CardioMEMS Trial: Device “Incredibly Compelling” But Concerns About Bias.
CardioMEMS nurse interventions thought by FDA panel to have introduced bias to randomised trial.
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.
CardioMEMS Device Safe According To FDA Panel, But Effectiveness Questioned.
A U.S.FDA panel has decided not to recommend CardioMEMS implantable heart device for treating heart failure because supporting clinical research may have been biased by human intervention.
Abbott Trials Absorb™ Bioresorbable Vascular Scaffold Against Metallic Drug Eluting Stent
Abbott today announced the initiation of ABSORB II, the first randomized, controlled, multi-center clinical trial to evaluate the safety, efficacy and performance of the Absorb™ bioresorbable vascular scaffold (BVS) compared to the company’s XIENCE PRIME™ Everolimus Eluting Coronary Stent System.
CE Mark Approval for Bausch & Lomb Victus Femtosecond Laser
First Single-Platform Femtosecond Laser Now Commercially Available in European Union
Medical Device Alert: Auxiliary Common Gas Outlet on Aestiva, Aisys, Aespire and Avance Anaesthetic Machinesed by Lifecare Hospital Supplies Ltd
UK MHRA has issued a Medical Devices Alert(MDA) relating to the Auxiliary Common Gas Outlet (ACGO) on all Aestiva, Aisys, Aespire and Avance anaesthetic machines manufactured by GE Healthcare.
Are You Carrying Your Pacemaker Donor Card?
Reusing Pacemakers from deceased donors is safe and effective, study finds.
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.
AtriCure Aiming At Thoracoscopic Indication For AtriClip LAA Occlusion Device
MedCity News has reported on AtriCure’s quest to gain approval for use of the device in a minimally invasive fashion in stand-alone procedures to close the LAA.
Rayner Receives CE Mark Approval for Sulcoflex® Multifocal Toric IOL
Rayner Intraocular Lenses Limited, the world’s original manufacturer of IOLs, has received CE Mark approval for the Sulcoflex® Multifocal Toric IOL.