Israeli airway management specialist ETView Medical Ltd. has announced that the company has received CE Mark clearance for its VivaSight™-DL product family. VivaSight™-DL comprises a dual lumen airway ventilation tube with an integrated, continuous high-resolution video airway imaging system permitting airway control and lung isolation during certain surgical procedures.
Approval/Clearance
FDA Clears Bausch + Lomb’s enVista™ “Glistening Free” Intraocular Lens
Eye health company Bausch + Lomb claims its newly FDA approved IOL is uniquely able to claim to be glistening free.
FDA Clears InTouch’s Remote Presence Telemedicine Devices For Active Patient Monitoring
California’s InTouch Health has announced that it has received FDA 510(k) clearance with expanded indications for use for its Remote Presence devices. The range is now approved for active patient monitoring rather than a medical device data system, thereby exemplifying the FDA’s new approach to telemedicine device classification.
FDA Clears More Sizes Of Chocolate™ PTA Balloon Catheter
Trireme hasn’t really explained why its PTA balloon catheter is called chocolate, but clinicians won’t care if FDA’s approval of further sizes means they can use it for more peripheral vascular indications.
CE Mark For Maquet’s Intergard Synergy Antimicrobial Vascular Graft
Maquet is trumpeting its new generation of antibiotic/silver treated vascular grafts which it claims are effective against MRSA. The graft, branded Intergard Synergy, has gained CE mark status and is ready for launch.
KFx Gains Foot And Ankle Tissue Fixation Indication As 5mm AppianFx® Gains FDA Clearance
KFx Medical Corporation has announced it has received FDA 510(k) clearance for its 5mm AppianFx® Tissue Fixation Anchor, opening the door to the growing foot and ankle tendon fixation market.
St.Jude’s Amplatzer™ Vascular Plug 4 Cleared By FDA For Peripheral Vessels
St. Jude Medical, Inc. has received FDA clearance and will immediately launch the Amplatzer™ Vascular Plug 4 for use in transcatheter embolisation procedures within the peripheral vasculature.
FDA Clears KCI’s V.A.C.® Therapy For Closed Surgical Incisions
Kinetic Concepts, Inc. announced today that it has received FDA 510(k) clearance to market its proprietary Vacuum Assisted Closure®, or V.A.C.® Therapy System, for the management of closed surgical incisions.
FDA 510(k) Clearance For Cardiosolutions’ Dexterity™ Steerable Introducer
Cardiosolutions Inc., has announced that it has received FDA 510(k) clearance to market its Dexterity Steerable Introducer, a next generation structural heart access introducer and delivery conduit.
FDA Panel Votes To Extend Sapien Valve Indication To Include High-Risk Patients
It seems members of the FDA Circulatory Devices Advisory Panel have satisfied themselves that the benefits of Edwards’ Sapien heart valve outweighed the risks for as it voted 11-0 in favour of approval of the device for use in high risk patients. The final decision will now rest with FDA itself.
FDA 510(k) For TransCorp Spine’s SpinePort™ Cervical Minimally-Invasive Access and Visualisation System
TransCorp Spine has received FDA 510(k) clearance for its SpinePort™ Spinal Access System which provides direct access and visualisation to aid surgeons in treating cervical spine pathologies through a transcorporeal microdecompression procedure.
CE Mark Approval For World’s First Rechargeable Vagus Nerve Stimulator To Treat Refractory Epilepsy
Treatment of Refractory Epilepsy by Vagus Nerve Stimulation is to be made available in Europe as Neurotech’s unique rechargeable device gains CE mark approval.
FDA Says Edwards Can Start Trial Of CE Marked Valve Technology
Edwards Lifesciences Corporation has received conditional IDE approval from the US FDA to initiate a clinical trial to study its GLX next-generation tissue treatment platform applied to a surgical bovine pericardial heart valve. It seems EU regulatory barriers are somewhat lower, the product having been CE marked in May.
FDA 510(k) Clearance For Magellan™ Peripheral Vascular Robotic System
Hansen Medical, Inc. has announced that it has received FDA 510(k) clearance for its Magellan™ Robotic System, opening the door for transformation of vascular interventions.
CE Mark For NinePoint Medical’s NvisionVLE™ Imaging System
NinePoint Medical, Inc., an emerging leader in the development of medical devices for in vivo pathology, has announced that it has gained CE mark approval for the NvisionVLE™ Imaging System.
FDA Approval and First US Surgeries For Medicrea’s LigaPASS™ Spinal Fixation System
Medicrea’s LigaPASS™ system enables spinal fixation in cases where pedicle fixation is complex or compromised. Now the product has gained FDA approval and seen its first use in US patients.