Codman Neuro has chosen the SNIS meeting at which to launch the ENVOY® DA XB Distal Access Guiding Catheter and the 7F ENVOY® Guiding Catheter for neurovascular procedures.
Neuro
Medtronic Boosts Neuro Portfolio with MIS Imaging Acquisition
Medtronic, Inc. has completed the acquisition of Visualase, Inc., and its FDA-approved MRI-guided laser and image guided system for minimally invasive neurosurgery.
NICE Consults on Device to Detect Diabetic Nerve Damage
The UK’s National Institute for Health and Care Excellence (NICE) has commenced a consultation on its draft medical technology guidance on a device which aims to diagnose nerve damage that is caused by diabetes.
FDA Approves Studies into Cooling of Heart Attack and Stroke Patients
The U.S. FDA has approved two investigational device exemptions (IDE’s) to study the use of the Life Recovery Systems ThermoSuit® in the treatment of heart attack and ischemic stroke.
FDA Class I Recall for Medtronic Duet External Drainage and Monitoring System
The Medtronic Duet External Drainage and Monitoring System is now the subject of a Class I recall because of concerns that tubing may separate, with serious consequences for patients.
European Launch of Covidien’s Pipeline™ Flex Embolization Device
Covidien has announced the launch of its new Pipeline Flex Neuro-Embolization device which is a minimally-invasive flow diversion device for unruptured brain aneurysms, now claiming more accurate, controlled placement.
InVivo Ditches Drug Delivery Gel and 28% of Staff
Getting a new technology to market is an expensive undertaking, and often painful too as InVivo Therapeutics is finding out as it ditches an R&D project and 28% of its staff while its Neuro-Spinal Scaffolds go through a lengthy regulatory approval process.
VBLOC® Vagal Blocking Obesity Therapy Would be First for Ten Years… if Approved
If FDA supports its advisory panel’s less than unanimous endorsement, EnteroMedics’ VBLOC will be the first device to be approved for Obesity treatment in ten years.
One-Year Results Back Up Vercise™ DBS System in Parkinsons
One year data demonstrate highly significant improvement in motor function for patients with Parkinson’s Disease when treated with Boston Scientific’s Vercise DBS system
FDA Approval for Covidien’s Neurovascular Micro Catheter
Covidien’s Apollo™ Onyx™ delivery Micro Catheter with Detachable Tip has gained FDA approval and will enhances the company’s Onyx™ Liquid Embolic System.
FDA IDE for PulseRider® Intracranial Bifurcation Aneurysm Device
Pulsar Vascular receives FDA IDE approval for the PulseRider® Aneurysm Neck reconstruction device for the treatment of intracranial bifurcation aneurysms
FDA Clearance for SpringTMS® Portable Migraine Treatment Device
With its new FDA clearance, SpringTMS becomes the first medical device available to patients in the United States to relieve the pain caused by migraine headaches that are preceded by an aura.
R&D Costs Ramp as InVivo Therapeutics Enters Clinical Phase
Less than a month ago we covered the news that InVivo Therapeutics Holdings Corp. was ready to start the first trial of its Neuro-Spinal Scaffold. Now the biomaterials company has reported financial results for the quarter ended March 31, 2014 and updated us on its business
Catch-up: Medtronic Wins CoreValve Stay and Covidien’s Pipeline Recall Gets FDA Class
Two of last week’s news items have moved on a bit over the Easter weekend: Medtronic’s increasingly acrimonious spat with Edwards over the respective companies’ transcatheter heart valve offerings, and Covidien’s recall being graded Class I by the FDA.
St. Jude Financials Show Revenue and Earnings Growth and Promise More of the Same
St. Jude is sounding punchy, expecting revenue gains based on a flurry of new product approvals.
FDA IDE Approval for BARREL® Intracranial Bifurcation Aneurysm Solution
Reverse Medical® Corporation has gained FDA IDE approval for clinical investigation of its BARREL® Vascular Reconstruction Device (VRD). The BARREL® Vascular Reconstruction Device is designed for use with occlusive devices in the treatment of intracranial bifurcation aneurysms.