When the purveyor of a new technology suggests its use should be mandated, we have to raise questions. When its decontamination related, who’s going to argue though?
Regulatory
FDA Approves CoreValve for Valve-In-Valve Use, Expanding Treatment Options
CoreValve becomes first TAVR device to be indicated for replacement of failed surgical heart valves, expanding the patient population that can benefit from this minimally invasive procedure
FDA Clearance for Wright Medical’s External Fixator
The SALVATION™ external fixation system forms an integral part of Wright’s Limb Salvage product portfolio
FDA Approval for Impella 2.5 in Elective and Urgent High Risk PCI
With this approval, Impella 2.5 becomes the only FDA-approved percutaneous hemodynamic support device for high risk indications
FDA and CE Mark Approval for Boston Scientific’s Thinner S-ICD System
Boston Scientific will be hoping its new S-ICD will prove popular based on its advantages over conventionally placed leads
FDA Approves Medtronic Protégé™ GPS™ Stent for Iliac Artery Stenosis
Supporting study points to 96% nine month patency and 99% freedom from target vessel revascularization
FDA Approves Boston’s WATCHMAN™ Left Atrial Appendage Closure Device
First-Of-Its-Kind alternative to long-term Warfarin therapy for stroke risk reduction in patients with non-valvular atrial fibrillation
CE Mark for Software to Help Diagnose Serial Lesions and Diffuse Coronary Disease
Philips’ newly acquired Volcano business has seen its iFR Scout Pullback software gain European regulatory approval
Otto Bock Claims New Michelangelo® Prosthesis Closest to a Human Hand
The most technologically advanced prosthetic hand in the world is changing the life of a 30 year amputee
FDA Clearance for joimax Percusys® Pedicle Screw-Rod System
Percutaneous pedicle screw-rod system aims at simple stabilization with minimal soft tissue damage
FDA Clears Office Alzheimers Test System
Neuronetrix’s Cognision™ system delivers the capability to test for Alzheimers in a primary care setting
FDA Panel Supports VertiFlex® Superion® Interspinous Spacer
FDA approval beckons with the strongly supportive expert panel vote for Vertiflex’s spinal implant
FDA Approval for Varicose Vein Glue
Less than 18 months since submitting the first part of a modular PMA, the VenaSeal varicose vein treatment system has now gained FDA PMA approval
12,000 GE MRI Systems at Risk of Life-Threatening Condition
GE Healthcare is pointing to in-field modifications for the introduction of a serious condition to many of its installed MRI systems around the world
Chair Appointed for Newly-formed UK’s Devices Expert Advisory Committee
Dr Peter Nightingale has been appointed as the first chairman of the UK MHRA’s newly formed Devices Expert Advisory Committee.
Precision Spine Talks Up Future
Precision Spine, Inc. says it has finalized a major financial agreement that will enable the company to refinance its existing debt and pursue strategic acquisitions.