Neuro

The U.S. FDA has cleared the eNeura Therapeutics’ Cerena Transcranial Magnetic Stimulator (TMS), making it the first device to relieve pain caused by migraine headaches that are preceded by an aura.

TYRX, Inc. has received U.S. FDA clearance to expand marketing indications of its AIGISRx® N Antibacterial Envelope to include use with spinal cord neuromodulators.

Medtronic’s Activa® PC+S Deep Brain Stimulation System closes the loop in understanding the impact of this therapy, by monitoring the impact of the therapy on specific areas of the brain in real time.

Neuro implant developer, NeuroPace has announced the U.S. FDA approval of its RNS Stimulator, a device to help reduce the frequency of seizures in epilepsy patients who have not responded well to medications.

Its been a good week for Reverse Medical Corporation, which has seen CE Mark approval, FDA 510k clearance and initial clinical use of its ReVerse® Microcatheter product line for intracranial neurovascular use.

Neuromonitoring device company Raumedic has gained FDA 510(k) clearance to market Neurovent®-PTO. The company says this is the only marketed device that combines measurement of intracranial pressure , intracranial temperature and oxygen partial pressure in one Catheter.

Integra LifeSciences Holdings Corporation is to acquire Covidien’s Confluent Surgical product lines, including surgical sealants, adhesion barrier, and, most significantly, … continue reading “Integra Seals Duraseal™ Deal”

Neurovascular technology company Pulsar Vascular has received European CE Mark approval for its lead product, the PulseRider®. The company says its device is designed to treat brain aneurysms in conjunction with embolic coils or flow diversion devices.

This time last year the news was filled with externalising ICD lead discussions, focusing to a large degree on St.Jude Medical. It seems a raft of clinical data has helped minimise the negative impact, while a healthy sales line and two exciting new acquisitions mean the company’s financial report is a positive sounding affair.

Following its CE mark earlier in the summer, Codman Neuro has launched its next generation thrombectomy device at minimally invasive neuro meeting, 2013 ESMINT in Nice last week.

IMRIS Inc. and MRI Interventions, Inc. have announced that a surgical team at Boston’s Brigham and Women’s Hospital has performed the first laser ablation procedure to combine the use of MRI Interventions’ ClearPoint® Neuro Intervention System as the navigation platform with intraoperative MRI in an IMRIS VISIUS® Surgical Theatre.

Study commences with first patient enrollment for NeuroStar TMS non-systemic, non-invasive neuromodulation in post-partum depression.

The Monarch eTNS System safely stimulates branches of the trigeminal nerve through the skin. In clinical trials, eTNS has been found to substantially reduce seizures in patients with epilepsy and reduce symptom severity in patients with depression, PTSD and ADHD. Now an IDE study is to start in the US.

If it’s true that Stryker has suffered from downward pricing pressure, foreign exchange pressure and absorbed recall costs this quarter, it’s perhaps not surprising they sound a bit pessimistic. But restructuring, acquisitions and positive mix changes suggest it’s not all that bad.

Terumo subsidiary, MicroVention, Inc., has successfully completed its first enrollment in a multi-center, prospective, pivotal U.S. clinical trial to demonstrate the safety and efficacy of its FRED™ flow diversion system for treating intracranial aneurysms.

Boston Scientific Corporation has launched a clinical trial to determine whether occipital nerve stimulation using the company’s Precision™ System can safely and effectively treat chronic migraine when used in conjunction with anti-migraine medications.