Neuro

St. Jude Medical, Inc. has reported sales and net earnings for the second quarter ended June 29, 2013. Background We … continue reading “Mixed Bag for St.Jude Medical Sees Cardiac Rhythm Business Propped Up by The Rest”

Israeli neuro device company, HeadSense, which is developing a non-invasive neurological monitor focused initially on an intracranial pressure application, has announced it has secured necessary financing for its venture.

For the first time in the UK, the RhinoChill® IntraNasal Cooling System is being jointly evaluated by an ambulance service … continue reading “First UK Evaluation of Continuous Targeted Brain Cooling In Cardiac Arrest From Street To ITU”

The U.S. FDA has cleared for marketing Rhythmlink’s Disposable MR Conditional Cup Electrodes, the first of a kind to be formally authorized for use.

Covidien has announced that the final results of the PUFs (Pipeline for Uncoilable or Failed Aneurysms) clinical study of its … continue reading “Pivotal Study Results For Covidien’s Pipeline™ Embolization Device”

Codman Neuro has announced the gaining of CE mark approval for its self-expanding clot removal device. The Revive SE nitinol basket for removal of clots in the treatment of ischemic stroke features newly enhanced navigation which should speed up restoration of blood flow.

The FDA has granted 510(k) clearance to a muscle and joint rehabilitation medical device that tricks the brain into re-establishing communication with muscles affected by brain or spinal cord damage.

joimax® will introduce its novel EndoLIF® system for endoscopic stabilization of the lumbar spine to the broad expert audience of DGNC’s Annual Meeting in Düsseldorf, Germany, this week.

Sequent Medical, Inc. has gained the CE mark for the SL (“Single Layer”) family of WEB® Aneurysm Embolization Devices, and … continue reading “CE Mark And EU Launch For Sequent Medical’s New SL Family of Web Aneurysm Embolization Devices”

Boston Scientific Corporation has gained CE Mark approval for use of the GUIDE™ DBS System, the world’s first deep brain … continue reading “CE Mark For Boston Scientific’s GUIDE™ DBS System”

In a story posted on Orthopedics This Week, the ongoing turf war between Neurosurgery, Orthopedics, Pain Management and other specialties is exposed through the recent New Jersey case of The New Jersey Board of Medical Examiners and Dr. Richard Kaul .

Medtronic’s Urgent Medical Device Correction notification relating to the use of potential damage associated with its Deep Brain Stimulation (DBS) lead kits and dystonia therapy kits has now been classified by the FDA as a Class I Recall, its most serious category.

In short Last summer we announced the CE marking of Blockade Medical’s cerebral aneurysm coil system, here. Now the company … continue reading “FDA 510(k) Clearance For Blockade Medical™ Barricade™ Coil System”

Integra LifeSciences has initiated a voluntary recall of certain products manufactured in its Añasco, Puerto Rico facility between December 2010 and May 2011 and between November 2012 and March 2013. It seems the Company identified that there may have been deviations from approved processes in their production rather than any specific product-related issues, but the impact on the numbers is real enough for the company to be issuing warnings of revenue and profits notices.

The CE mark approval of St.Jude’s deep brain stimulation devices represents the first by a regulatory agency for the use of deep brain stimulation to manage both primary and secondary dystonia.

Monteris® Medical has announced that the U.S. FDA has issued a second 510(k) clearance for its MRI-guided ablation device for brain tumors and other lesions.