NeuroMetrix, Inc., a medical device company focused on the treatment of the neurological complications of diabetes, reported that the SENSUS Pain Management System became the first transcutaneous electrical nerve stimulator to receive 510(k) clearance (K130919) from the U.S. Food and Drug Administration (FDA) for use during sleep.
The U.S. Food and Drug Administration today allowed marketing of the first medical device based on brain function to help assess attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old. When used as part of a complete medical and psychological examination, the device can help confirm an ADHD diagnosis.
The real time monitoring of brain function has advanced in leaps and bounds in recent years. That’s largely thanks to various new technologies that can monitor the collective behaviour of groups of neurons, such as functional magnetic resonance imaging, magnetoencephalopathy and positron emission tomography.
First experiencing symptoms at just 29-years-old and diagnosed with Parkinson's at age 34, Tommy Zuleger is the youngest patient ever treated at the Muhammad Ali Parkinson Center at Barrow Neurological Institute in Phoenix and he says a new "sci-fi" procedure has given him his life back.
NeuroMetrix's (NSDQ:NURO) Sensus wearable pain management device can now be paired with pajamas thanks to the FDA's clearance of the device for use during sleep. The FDA typically requires warning labels for transcutaneous electrical nerve stimulators like Sensus because of their tendency to dislodge during sleep, which may pose an electrical hazard.
Scientists have created a virtual model of the brain that daydreams like humans do. Researchers created the computer model based on the dynamics of brain cells and the many connections those cells make with their neighbors and with cells in other brain regions.
A new proposal from the Centers for Medicare & Medicaid Services would help level at least 1 battlefield between radiosurgery devices makers Elekta and Varian Medical Systems. The reimbursement proposal would offer equal payment to healthcare providers conducting single-treatment radiosurgery for brain tumors, whether the procedure is conducted with Elekta's Gamma Knife or Varian's Linac.
On this episode of The Pulse, a device that helps train the brain to turn sounds into images, detecting cancer by imaging the consumption of sugar, biomedical applications for a new hydrogel, and a nanofiber mesh that treats tumors with both thermotherapy and chemotherapy.
Putting medical devices on the network provides a large number of benefits, such as supporting telemedicine and the easy transfer of test results to electronic medical records (EMR) systems. However, putting these devices on a network also introduces a number of risks.
Is there a brain area for mind-wandering? For religious experience? For reorienting attention? A recent study casts serious doubt on the evidence for these ideas, and rewrites the rules for neuroimaging. Brain mapping experiments attempt to identify the cognitive functions associated with discrete cortical regions.
X2 Biosystems, a medical device company that's developing sensors for sports brain injuries, drummed up $3.3 million of a hoped-for $12.5 million raise, according to a regulatory filing. Eighteen unnamed investors kicked in on the round, according to the filing.
A new study suggests that CPAP therapy reduces nightmares in veterans with post-traumatic stress disorder and obstructive sleep apnea. Results show that the mean number of nightmares per week fell significantly with CPAP use, and reduced nightmare frequency after starting CPAP was best predicted by CPAP compliance.
Early signs of Alzheimer’s disease can be detected years before diagnosis, according to researchers at Birmingham City University. The study found that sufferers of a specific type of cognitive impairment have an increased loss of cells in certain parts of the brain, which can be vital in detecting which patients will progress to a diagnosis of Alzheimer’s.
A nonsurgical procedure offered at the University of Florida Health Spine & Sports Intervention Center uses Cervicool, a water-cooled radiofrequency system by Kimberly-Clark Corp., to treat the facet joints in the neck to relieve pain.
Neurodegenerative diseases such as Alzheimer's could be better understood thanks to insight into proteins linked to such conditions, a study suggests. Scientists studying thread-like chains of protein have found that low levels of these proteins may cause more harm to health than high levels.
Older adults diagnosed with brain disorders such as Parkinson’s disease often feel a loss of independence because of their lack of mobility and difficulty walking. To better understand and improve these mobility issues, a research team is working toward building a more advanced motion test.
To unlock the potential of more frequent therapy, medical devices must move out of the doctor’s office and travel with patients to their homes and offices. But, this great opportunity is not without its challenges. The same patient who stands to reap great benefit from a home medical device may instead endanger themselves by applying the device incorrectly.
A spinal cord injury changes the functional state and structure of the spinal cord and the brain. For example, the patients' ability to walk or move their hands can become restricted. How quickly such degenerative changes develop, however, has remained a mystery until now.
As Parker sees it, the three biggest obstacles to [design] success for patient care products, such as oxygen concentrators and ventilators, are portability, battery life, and reliability. To make home care products more portable, Parker has reduced the size of some valves up to 75%.
Is it possible, that in 2-3 years Brits, Germans, Scandinavians, and Russians will undergo cancer treatment, orthopaedic, or cardiac surgery procedures in Polish medical facilities more often? Treat teeth and get implants in dental clinics; take a cure in Polish sanatoriums?
In the latest issue of Neuron, a team led by Gladstone Investigator Anatol Kreitzer, PhD, and Salk Investigator Edward Callaway, PhD, combined mouse models with a sophisticated tracing technique—known as the monosynaptic rabies virus system—to assemble brain-wide maps of neurons that connect with the basal ganglia, a region of the brain that is involved in movement and decision-making.
People who have a traumatic brain injury (TBI) may be more likely to have a future stroke, according to research that appears in the June 26, 2013, online issue of Neurology®, the medical journal of the American Academy of Neurology.
The antibacterial effects of silver are well established. Now, researchers at Yonsei University in Seoul, Republic of Korea, have developed a technique to coat glass with a layer of silver ions that can prevent growth of pathogenic bacteria including Escherichia coli, Salmonella typhimurium and Campylobacter jejuni. The technology could be used to protect medical equipment.
With the 3rd Edition of IEC 60601-1 impacting U.S. design engineers in June, it is critical they are aware of the implications to their medical device designs. For home healthcare devices, there is a collateral standard that will have a specific effect. This article focuses in on powering these products and the items in the standard of significance for that aspect.
These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis. A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.