Medtronic, Inc. has announced the global market introduction of the CD HORIZON® SOLERA® Spinal System Sagittal Adjusting Screw (SAS) which … continue reading “Medtronic’s New Screw for Medtronic’s CD HORIZON® SOLERA® Spinal System Offers Enhanced Positioning”
Products
Stentys Self-Apposing Stent Gets Broader Coronary Indications
Stentys, developer of the world’s first and only Self-Apposing® Stent to treat acute myocardial infarction (AMI), has received approval to … continue reading “Stentys Self-Apposing Stent Gets Broader Coronary Indications”
Remote Medical System Provides Global Remote Access To Medical Advice
Remote Medical International launched RMI CONNECT, a global telemedicine service that provides integrated medical support.
Pitched at people working in far flung reaches of the world, the company says RMI CONNECT clients receive unlimited access to comprehensive medical advice and logistical support worldwide, 24 hours a day, 7 days a week, 365 days a year.
FDA PMA for CryoLife’s New Sologrip Minimally Invasive TMR Laser Fiber-Optic Delivery System
CryoLife, Inc.has announced that it has received U.S. FDA premarket approval for its new Sologrip® minimally invasive laser fiber-optic delivery system, a single-use, disposable handset designed for use with the Company’s Cardiogenesis transmyocardial revascularization system.
Japanese Approval For Abbott’s XIENCE Xpedition™ Drug Eluting Stent
Abbott has announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved the XIENCE Xpedition™ Everolimus Eluting Coronary … continue reading “Japanese Approval For Abbott’s XIENCE Xpedition™ Drug Eluting Stent”
FDA Clears Antibacterial Pacemaker Envelope
Tyrx Inc’s, Inc. fully Resorbable AIGISRx® R Antibacterial Envelope for use with pacemakers and implantable cardioverter defibrillators has gained U.S. FDA clearance.
SENSUS™ Diabetes Pain Management System Now Indicated While Sleeping
NeuroMetrix, Inc., a medical device company focused on the treatment of the neurological complications of diabetes, reported that the SENSUS Pain Management System has become the first transcutaneous electrical nerve stimulator to receive FDA 510(k) clearance for use during sleep.
CE Mark for Cormedix Neutrolin® Catheter Lock Solution
CorMedix Inc. has gained CE Mark approval for Neutrolin®, a catheter lock solution for patients with central venous catheters on hemodialysis secondary to advanced chronic kidney disease.
CE Mark For Episurf’s Episealer® Customised Cartilage Replacement Device
Stockholm based Episurf Medical has gained CE Mark certification for its personalised Episealer® implant for the treatment of femoral condyle cartilage defects in the knee.
CE Mark And EU Launch Of Integra® Smart Cervical Solution
Integra LifeSciences Holdings Corporation has received European CE Mark for its Integra® Smart Cervical Solution, a device for treating degenerative diseases of the cervical spine that require stabilization and fusion of two or more cervical vertebrae.
FDA Clearance For Philips AlluraClarity Interventional X-ray System
Philips says its newly FDA cleared AlluraClarity system with its powerful ClarityIQ technology provides high quality imaging for a comprehensive range of clinical procedures, achieving excellent visibility at low X-ray dose levels for patients of all sizes.
Retina Implant AG’s Alpha IMS Wins CE Mark
Retina Implant AG, the leading developer of subretinal implants for patients blinded by retinitis pigmentosa, has announced that its wireless subretinal implant technology, the Alpha IMS, has received CE Mark.
MRI Systems Market to 2018: MRI Compatible Pacemakers A Growth Driver
A new market intelligence report provides the landscape and market trends on the three MRI systems market segments: low-field MRI systems, mid-field MRI systems and high-field MRI systems segments.
Orthofix Launches Trinity® ELITE™ Moldable Bone Graft
Orthofix International N.V., in collaboration with the Musculoskeletal Transplant Foundation (MTF), has announced the full market release of Trinity® ELITE™ … continue reading “Orthofix Launches Trinity® ELITE™ Moldable Bone Graft”
FDA’s Sleep-Over At Intuitive Yields Troubling Observations
Just in case you don’t think the FDA keeps on top of the companies under its watchful eye, take a … continue reading “FDA’s Sleep-Over At Intuitive Yields Troubling Observations”
Globus Medical Launches LATIS™ MIS Expandable Lumbar Interbody Spacer
Spinal implant manufacturer Globus Medical, Inc. is launching a minimally invasive (MIS) lumbar interbody fusion spacer for patients suffering from … continue reading “Globus Medical Launches LATIS™ MIS Expandable Lumbar Interbody Spacer”