Archive for the 'Devices & Systems' Category

AbsolutelyNew Licenses The Headache Reliever(TM) Treatment Band

AbsolutelyNew, Inc., has signed an exclusive licensing and manufacturing deal with inventors Dr. Stephen Landy of Memphis, TN and Brand Griffin of Huntsville, AL.  The Headache Reliever(TM) band invented by the company will be available in the market by early 2009. The product is clinically proven to reduce tension and migraine headache pain without drugs and their side-effects. It does this via a pressure band that gently compresses blood vessels, reusable and microwavable hot packs, freezer-friendly cold packs that cool and constrict blood vessels.

FDA clearance to US Spine’s Preference 2 Complex Spine System™

The U.S. Food and Drug Administration has cleared US Spine’s Preference 2 Complex Spine System™ for use in the United States. With this approval, US Spine makes an entry into the deformity and trauma market. Designed by some of the leading spine surgeons for the treatment of complex spinal conditions, the system is featured by a number of new components that include hooks, screws and rods. The anchoring implants in the system are featured by Helical Flange® Closure mechanism that reduces cross threading drastically and eliminates head splay.

FDA nod to Neuronetics’ Neurostar TMS system

The U.S. Food and Drug Administration has cleared Neuronetics, Inc.’s NeuroStar Transcranial Magnetic Stimulation (TMS) system for treating Major Depressive Disorder in adults whose condition did not improve by the intake of minimally effective dose of an antidepressant. A non-systemic and non-invasive solution for depression, the NeuroStar TMS device delivers magnetic pulses to stimulate nerve cells of that area of the brain which is associated with depression. Patients do not need to be anesthetized and the whole outpatient procedure is over in 40 minutes.

FDA approves ThermoSuit(R) System for clinical study

The U.S. Food and Drug Administration has approved Life Recovery Systems‘ ThermoSuit(R) System, a rapid patient cooling device for use in a clinical study of patients suffering from traumatic brain injury. Till now, the system has been in use to induce rapid cooling of heart patients only.The study which will be conducted at the University of Texas Health Science Center in Houston will investigate whether the induction of hypothermia will result in higher number of patients coming up with good outcomes at six months and 12 months after injury as compared to patients who were randomized to normothermia.


Novel Imaging Approach Detects Tumors Earlier

Researchers at Barrow Neurological Institute (St. Joseph’s Hospital) and the Montreal Neurological Institute recently carried out a pilot study which suggests that a certain type of MRI scanning can proactively detect whether a patient is failing brain tumor treatment. It assesses the response before symptoms appear. Patients with recurring malignant brain tumors received scans through an imaging device known as MR spectroscopy. This device identifies metabolic changes. The study concluded that the use of metabolic imaging can identify chemical changes earlier than the technology of structural imaging such as CT scan or a conventional MRI. This imaging can be done frequently. It is non-invasive and poses no radiation hazards.

STARband cranial helmets proving a good cure for asymmetrical skull growth

STARbandSurgeons are using custom-made, FDA-approved device, STARband, to begin the cranial shaping process of children below 18 months of age diagnosed with craniosynostosis. Craniosynostosis is a condition that leads to premature fusion of the cranial sutures, or fontanels, causing problems with normal brain and skull growth, which can result in developmental delays, visual impairment and misaligned ears, eyes, and jaws. Orthomerica Products Inc.’s STARband helmets, which are worn 23 hours daily for three to six months, channel head growth by applying constant and gentle pressure on raised areas of the head, while leaving room for growth in depressed areas.

Quadriplegics to control devices by brain signals

European researchers have offered new hope for quadriplegics (people paralyzed from the neck down) through a technology that uses brain signals to control computers, artificial limbs and even wheelchairs. Quadriplegic patients, who are paralyzed neck down due to spinal injuries or neurodegenerative diseases, can now be independent to some degree due to this new type of brain computer interface that is non-intrusive.

This new type of non-intrusive brain-computer interface, or BCI, has been developed by the MAIA project. So far, the team, led by the IDIAP Research Institute in Switzerland, has carried out a series of successful trials in which users have been able to manoeuvre a wheelchair around obstacles and people using brainpower alone.

UCI to study novel method to treat pain, depression

UCI researchers are studying handheld electrical devices that have been invented by Dr. Leon Silverstone and are being prepared for regulatory approval by NeuroMed Devices Inc. These devices aim at combating pain and depression by attacking the nervous system. While this technology’s therapeutic effects are supported by case studies, there is not much hard data from scientifically controlled clinical trials, a shortcoming that UCI aims to overcome through its study, with funding from NeuroMed.