One of the smaller devices featured on our pages, but nonetheless significant. Californian ophthalmic device company Glaukos has gained FDA approval for its iStent device, which relieves intraocular pressure in glaucoma patients.
FDA Approval
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.
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) 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.
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.
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.
FDA Approves Longer Lengths Of PROMUS Element Plus Stent
Boston Scientific Corporation has announced the gaining of FDA clearance of two longer lengths (32mm and 38mm) of its PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System, opening the door for the treatment of longer lesions.
Boston Scientific Claims Its U.S. Defibrillators Enjoy Increased Longevity. FDA Agrees
The U.S. FDA has approved revised product labeling for the Boston Scientific Corporation INCEPTA™, ENERGEN™, PUNCTUA™, COGNIS® and TELIGEN® implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), to reflect increased longevity projections for these devices.
FDA Clearance For Teleflex ARROW FlexTip Plus Closed Tip, Multi-Port Epidural Catheter
Teleflex Inc. has announced that its Arrow FlexTip Plus Closed Tip, Multi-Port epidural catheter has received FDA 510(k) clearance, bringing claimed reduced complications to epidural catheter insertion.
FDA 510(k) Clearance for ViewRay’s MRI-Guided Radiation Therapy System
Cleveland medical device company ViewRay Inc., has received U.S. FDA 510(k) premarket notification clearance for its MRI-guided radiation therapy system. The ViewRay system features what the company calls a unique combination of radiotherapy delivery and simultaneous magnetic resonance imaging (MRI) for the treatment of cancer.
FDA Clearance For Endoscopic Gastro-Oesophageal Reflux Disease Device
Israeli device company Medigus Ltd. has announced that it has received FDA 510(k) clearance for its SRS endoscopic system, designed for minimally-invasive endoluminal treatment of Gastro-oesophageal reflux disease.
FDA Clears Boston Scientific To Expand Indications For CRE™ Balloon To Include Into Stone Extraction
Boston Scientific Corporation has announced the FDA clearance for an expanded use indication for the CRE™ Wireguided Balloon Dilator for endoscopic dilation of the Sphincter of Oddi following sphincterotomy, quite literally opening up the possibility of using it for dilation assisted stone removal.