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PMA Final Decisions for April 2013

June 26, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

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.

Effects of DBS on Motor Symptoms of Parkinson's Disease

June 25, 2013 11:49 am | by Andrew Johnson | Videos | Comments

In November 2012 and February 2013, Andrew Johnson underwent a surgical procedure, Deep Brain Stimulation surgery, to help control his motor symptoms. This video represents his experience of how DBS has helped him. He is using a device from Medtronic.

Problem-Solving Governs How We Process Sensory Stimuli

June 25, 2013 11:28 am | by University of Zurich | News | Comments

Various areas of the brain process our sensory experiences. How the areas of the cerebral cortex communicate with each other and process sensory information has long puzzled neuroscientists. Exploring the sense of touch in mice, brain researchers from the University of Zurich demonstrate that the transmission of sensory information from one cortical area to connected areas depends on the task to solve and the goal-directed behavior.

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Past Brain Activation Revealed in Scans

June 25, 2013 11:11 am | by Weizmann Institute of Science | News | Comments

What if experts could dig into the brain, like archaeologists, and uncover the history of past experiences? This ability might reveal what makes each of us a unique individual, and it could enable the objective diagnosis of a wide range of neuropsychological diseases.

EnteroMedics Submits PMA Application for FDA Approval of VBLOC Therapy in Obesity

June 25, 2013 7:01 am | by The Associated Press | News | Comments

EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that the Company has submitted a Premarket Approval (PMA) application to the U.S. Food...

Potentially Life-Saving Cooling Treatment Rarely Used for In-Hospital Cardiac Arrests

June 24, 2013 10:13 am | by University of Pennsylvania School of Medicine | News | Comments

The brain-preserving cooling treatment known as therapeutic hypothermia is rarely being used in patients who suffer cardiac arrest while in the hospital, despite its proven potential to improve survival and neurological function, researchers from the Perelman School of Medicine at the University of Pennsylvania report in the June issue of Critical Care Medicine.

Evergreen Medical Technologies Launches Integrated Lead to Pulse Generator Interconnect System for Implantable Neurostimulators

June 21, 2013 2:46 pm | by Business Wire | RMS, Bal Seal Engineering, Inc. | News | Comments

Evergreen Medical Technologies has launched the Encompass Lead-Interconnect System, the first pretested integrated lead-interconnect system designed for implantable neurostimulator pulse generator (IPG) devices. The Encompass, enabled by Bal Seal Engineering’s SYGNUS® implantable contact system and rms Company’s premolded 16-channel header technology, saves development time and costs for neurostimulation device companies.

MEDICA Conferences & Forums

June 21, 2013 1:50 pm | by Messe Düsseldorf | Events

The conference program for MEDICA 2013, International Trade Fair with Congress – World Forum for Medicine, is undergoing a full re-launch. The content repositioning for MEDICA 2013 (to be held from November 20 – 23, 2103 in Düsseldorf, Germany) is designed to closely fit the program of the trade fair’s topics relevant to medical equipment users and to expand the international side of the program.

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Carbon Nanotube Harpoon Catches Individual Brain Cell Signals

June 21, 2013 9:32 am | by Ashley Yeager, Duke University | News | Comments

Neuroscientists may soon be modern-day harpooners, snaring individual brain-cell signals instead of whales with tiny spears made of carbon nanotubes. The new brain cell spear is a millimeter long, only a few nanometers wide and harnesses the superior electromechanical properties of carbon nanotubes to capture electrical signals from individual neurons.

BigBrain: An Ultra-High Resolution 3-D Roadmap of the Human Brain

June 21, 2013 9:18 am | by American Association for the Advancement of Science | News | Comments

A landmark three-dimensional (3-D) digital reconstruction of a complete human brain, called the BigBrain, now for the first time shows the brain anatomy in microscopic detail—at a spatial resolution of 20 microns, smaller than the size of one fine strand of hair—exceeding that of existing reference brains presently in the public domain.

Lumosity's Big Data Provides New Approach to Understanding Human Cognition

June 21, 2013 9:16 am | by Lumosity | News | Comments

Lumosity, the leading brain training company, today announced a new web-based, big data methodology for conducting human cognitive performance research. Lumosity's research platform, the Human Cognition Project, contains the world's largest and continuously growing dataset of human cognitive performance, which currently includes more than 40 million people who have been tracked for up to 6 years.

Covidien Announces Publication of Final Results of Pipeline Embolization Device Pivotal Study

June 21, 2013 7:00 am | by Business Wire | News | Comments

Covidien (NYSE:COV), a leading global provider of healthcare products, today announced that the final results of the PUFs (Pipeline for Uncoilable or Failed Aneurysms) clinical study of its Pipeline™ embolization device have been published in the June issue of Radiology. Radiology is the official peer-reviewed medical journal of the Radiological Society of North America.

From Orthopedics to Power Transfer—A Bright Future for Implants

June 19, 2013 4:51 pm | by Kasey Panetta, Managing Editor, ECN | Articles | Comments

Much like other medical technology, implants are adapting to a post-depression economy brimming with new materials, new ideas, and ambitious plans for the future. The result is a focus on designing safer, more bio-compatible products for local markets.

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Fiber-Optic Pen Helps See Inside Brains

June 19, 2013 1:35 pm | by Doree Armstrong, University of Washington | News | Comments

For less than $100, University of Washington researchers have designed a computer-interfaced drawing pad that helps scientists see inside the brains of children with learning disabilities while they read and write.     

Boston Scientific Vercise DBS System Demonstrates Improvement in Motor Function for Patients with Parkinson's Disease

June 18, 2013 12:00 am | by PR Newswire | News | Comments

Patients with Parkinson's disease using the Boston Scientific Corporation Vercise™ DBS (deep brain stimulation) System showed a significant improvement in motor scores according to interim data from the VANTAGE DBS study. The Vercise DBS System incorporates multiple independent current control, which is designed to selectively stimulate targeted areas in the brain, providing physicians with fine control of stimulation.

Russian Tycoon Wants to Move Mind to Machine

June 17, 2013 11:58 am | by Peter Svensson, AP Technology Writer | News | Comments

Can the City That Never Sleeps become the City That Never Dies? A Russian multimillionaire thinks so. Dmitry Itskov gathered some of humanity's best brains — and a few robots — in New York City on Saturday to discuss how humans can get their minds to outlive their bodies.  

Testing Method Promising for Spinal Cord Injuries, Multiple Sclerosis

June 14, 2013 9:00 am | by Purdue University | News | Comments

A medical test previously developed to measure a toxin found in tobacco smokers has been adapted to measure the same toxin in people suffering from spinal cord injuries and multiple sclerosis, offering a potential tool to reduce symptoms.

Codman Neuro Obtains CE Mark for Thrombectomy Device

June 13, 2013 4:33 pm | by Codman Neuro | News | Comments

Codman Neuro, part of DePuy Synthes Companies of Johnson & Johnson, has obtained CE marking for REVIVE SE, a next-generation self-expanding clot removal device for use in treating acute ischemic stroke, the company announced today at the Live Interventional Neuroradiology & Neurosurgery Course (LINNC) in Paris.

UF Study Finds Brain-Imaging Technique Can Help Diagnose Movement Disorders

June 13, 2013 11:15 am | by University of Florida | News | Comments

A new University of Florida study suggests a promising brain-imaging technique has the potential to improve diagnoses for the millions of people with movement disorders such as Parkinson’s disease. Utilizing the diffusion tensor imaging technique, as it is known, could allow clinicians to assess people earlier, leading to improved treatment interventions and therapies for patients.

The Pulse: New Interface Rewires Nerves from Amputated Limbs

June 13, 2013 9:43 am | by Eric Sorensen, Coordinator of Multimedia Development | Videos | Comments

On this episode of The Pulse, rewired nerves from amputated limbs allow for prosthetic control with existing muscles, a bioengineered blood vessel is transplanted, diabetes is diagnosed through breath analysis alone, and a new technology is paving the way for low-cost electronic devices that work in direct contact with living tissue inside the body.

Nerve Interface for Direct Sensory Feedback

June 12, 2013 10:33 am | by DARPA | Videos | Comments

Researchers at Case Western Reserve University used a flat interface nerve electrode (FINE) to demonstrate direct sensory feedback. By interfacing with residual nerves in the patient's partial limb, some sense of touch by the fingers is restored. Other existing prosthetic limb control systems rely solely on visual feedback.

Targeted Muscle Re-innveration for Advanced Prosthetic Control

June 12, 2013 10:26 am | by DARPA | Videos | Comments

A team of researchers at the Rehabilitation Institute of Chicago (RIC) demonstrated a type of peripheral interface called targeted muscle re-innervation (TMR). By rewiring nerves from amputated limbs, new interfaces allow for prosthetic control with existing muscles. Former Army Staff Sgt. Glen Lehman, injured in Iraq, recently demonstrated improved TMR technology.

New Nerve and Muscle Interfaces Aid Wounded Warrior Amputees

June 12, 2013 10:18 am | by DARPA | News | Comments

Since 2000, more than 2,000 servicemembers have suffered amputated limbs. DARPA’s breakthrough research with advanced prosthetic limbs controlled by brain interfaces is well documented, but such research is currently limited to quadriplegics; practical applications of brain interfaces for amputees are still in the future. In contrast, nerve and muscle interfaces allow amputees to control advanced prosthetics in the near term.

Exercise for Stroke Patients' Brains

June 12, 2013 9:56 am | by University of Southern California | News | Comments

A new study finds that stroke patients' brains show strong cortical motor activity when observing others performing physical tasks—a finding that offers new insight into stroke rehabilitation. A team of researchers monitored the brains of 24 individuals as they watched others performing actions made using the arm and hand that would be difficult for a person who can no longer use their arm due to stroke.

New Tasks Become as Simple as Waving a Hand with Brain-Computer Interfaces

June 12, 2013 9:51 am | by Michelle Ma, University of Washington | News | Comments

Small electrodes placed on or inside the brain allow patients to interact with computers or control robotic limbs simply by thinking about how to execute those actions. This technology could improve communication and daily life for a person who is paralyzed or has lost the ability to speak from a stroke or neurodegenerative disease.

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