Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Monday, April 2, 2012

PEER evaluation of EEGs??.

I do not know what this PEER is about!!?., but they claim that a EEG evaluation software developed by physicians to address what type of drug treatment regiment can be appropriate for certain mental illness??. I have no idea about what this method or test is about, and I have nothing to say as far as it validity and clinical usefulness, since it is related to neuroscience and monitoring related area, I thought to post it here.

CNS Response Details Response to FDA Feedback on Investigational Device

Company plans to design revised protocol and launch a clinical trial with the Walter Reed National Military Medical Center.
Scottsdale, AZ (PRWEB) March 25, 2012
QualityStocks would like to highlight CNS Response, a publicly traded company providing reference data and analytic tools for clinicians and researchers in psychiatry.
The company offers an online registry, developed by physicians, that enables qualified medical professionals to exchange objective, statistical neurophysiology-based data on individual patient medication response and outcomes.
In the company’s news last week,
CNS Response announced that the U.S. Food and Drug Administration (FDA) has responded to the company’s proposal for a clinical trial of an investigational device, PEER Interactive, designed to help physicians identify the best treatments for certain mental illnesses.
PEER Interactive, a Web service based on a standard electroencephalogram (EEG), records a patient’s brain function much like an electrocardiogram (EKG) does for the heart. The Psychiatric EEG Evaluation Registry (PEER) was developed by physicians as a quality assurance tool to determine which psychiatric medications are effective and which are not.

Wednesday, June 3, 2009

NeuroMonitoring News!

Clinic Meditex Opens Neurophysiology Service in Angola (Neurophysiology in Cuba?)

Summary: 
12/06/2010. Meditex medical clinic, where Cuban collaborators 
are working, opened on Monday a new neurophysiology service, 
with high technology equipment produced by the
Center for Neurosciences of Cuba.

SEDLine™ Announces Acquisition of Hospira 

Brain Function

SEDLine™ Announces Acquisition of Hospira 
Brain Function Monitoring Business
 New company formed to advance 
neuromonitoring technologies to 
improve the care of patients under
anesthesia or sedation
*******************Business Wire*****************
IRVINE, Calif. -- January 12, 2010
SEDLine™, Inc., announced today that it has 
acquired the brain functionmonitoring business of 
Hospira, Inc. (NYSE:HSP). Privately held and
 backedwith an investment from Masimo
 Corporation (NASDAQ:MASI), SEDLine, 
Inc., basedin Irvine, California, was formed
 with the mission to advance neuromonitoringtechnologies
 to improve the care of patients under anesthesia 
or sedation
FDA Approves Bryan Cervical Disc for Radicular, 
Intractable Neck or Arm Pain 
Laurie Barclay, MDAuthors and Disclosures Information 
from Industry Evidence from the GAIT studyshows a compelling
 risk-benefit ratio for nutraceuticals with glucosamine and
chondroitin.Learn more from an Expert Interview with 
David Hungerford, MDJune 3, 2009 — On May 12, 
the US Food and Drug Administration (FDA) approved 
the Bryan Cervical Disc (Medtronic; Memphis, Tennessee)
 for replacement of diseased or bulging cervical disc at the
 C3 to C7 level that is causing radicular, intractable neck or arm pain.
This device is constructed of 2 primary titanium pieces separated by a polyurethane part. After surgical removal of the diseased disc, the new cervical disc device is positioned in milled pockets in the adjacent vertebral bodies.The approved indication for use is to replace a cervical disc from C3 to C7 once it is removed in patients who have failed at least 6 weeks of conservative therapy for intractable radiculopathy and/or myelopathy secondary to disc degeneration or herniation. Anticipated outcomes from device implantation include pain relief and improved function.
Like a spinal fusion procedure, this device is intended to improve postoperative stability of the operated cervical level. Unlike conventional spinal fusion, however, the cervical disc device is intended to allow motion at the operated spinal level.
Medtronic launches intraoperative nerve integrity monitors for surgeons

9 October 2009
Medtronic (NYSE: MDT) has launched the NIM-Response 3.0 and NIM-Neuro 3.0 intraoperative nerve integrity monitors designed for a variety of surgeons, including ear, nose, and throat (ENT); endocrine; general; and peripheral surgeons.
During minimally invasive or traditional open surgery, Medtronic’s Nerve Integrity Monitor (NIM) systems enable surgeons to identify and confirm motor nerve function and monitor major motor nerves throughout the body, such as cranial nerves in a patient’s head, face and neck.

Search about: Neuromonitoring

NeuroMonitoring Companies: Europe

Providers in Europe:
Intraoperative Neuromonitoring Practice at UniversitatsSpital Zurich:

NeuroMonitoring Suppliers in Europe:
1.CPS Medical: NeuroCode AG

NeuroMonitoring Supplier in Russia:
1.Neurosoft, Medical Diagnostic Equipment
Worldwide Distribution list

IONM in New Zealand:

What are the chances of getting a job?

Opportunities to get into neurophysiology technologist jobs are very limited, as there are only 20 neurophysiology technologists employed in New Zealand.

IONM in Switzerland:
Anandic Medical Systems a local Swiz company with GE Partnership that does neuromonitoring and neonatal pediatric neuromonitoring monitoring.

Medical/Health Care: Insurance Companies and IONM Policies, in their Eyes!?

Here is what the insurance Co Anthem Blue thinks about what is medically necessary or investigational as per their policies!

BlueCross BlueShield of Tennessee Medical Policy Manual

  • Intraoperative neurophysiologic monitoring, including, but not limited to the following: Somatosensory-evoked potentials, brainstem auditory-evoked potentials, visual-evoked potential, EMG, motor-evoked potentials, and EEG, when performed during spinal, intracranial, or vascular procedures, is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)

  • Intraoperative neurophysiologic monitoring for other indications is considered investigational.

  • Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational. See also: Visual and Auditory Evoked Potential

Beware:- Do We Need this column?

Moved from Main page:-
Do Not Become victim to some New Org, association or society...! WARNING:- Be careful in signing up to some rogue organizations and memberships, You must realize that even professionals become prey for such tactics of bottom feeders, just think before you pay that fee, do we need another neuromontioring group, or organization or association bullshit?. They do not deserve to be even in the radar of scientific and medical communities, sorry!!!. I can only alert you, the rest is in your own hands, just because some one claims to have done or do the same kind of job a Professional and trained scholar can do, it means a jack shit!!!?, A doctor and a Doctarate cannot be replaced, those who claims to be doing some jobs can do something, but be careful to assess or compare it to a Doctor or Doctorate, such comparison will fail!!!. Society for Neuroscience and American Association of Anatomists are some of the most respectable and reputed scientific organizations, I dropped off my membership mainly because of their increased fees, I thought it was unjustified and unreasonable, but my respect to those two organizations will never be altered, they deserve great respect for what they do. Tthis message is not about such great associations, on the other hand it is about some rogue individuals trying to con the school students in IONM field or undergraduates who call themselves to be a neurophysioliogist??.Do not think that all the scientific or clinical organizations out there deserve the same respect like that of society for neuroscience or American association anatomists or American clinical Neurophysiologists or least they do the right things!!. Oh wait that is for those established organizations are out there already not for some rogues, but I have been seeing some internet activities of some rogue and decorated Neuromonitoring associations and societies trying to sprung up, just be careful about such org.The above message I had put up on my LinkedIN is to alert you, there are only a couple of Neuromonitoring associations established and in business already and they are good enough, we do not need every tom, dick and harry who did not even go to graduate school to start a association in the name of he or she is a tech for 10000 surgical cases, a Doctor and Doctorate cannot be replaced and there is no exception to it, so beware about rogue people starting societies and organizations and do not waste your hard earned money and resources to it...... stick to the deserved.