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NeuroSigma Awarded Fast Track SBIR Grant for Development of Implantable sTNS System for Drug Resistant Epilepsy

February 4, 2013 7:01 am | by The Associated Press | News | Comments

NeuroSigma, Inc., a California-based medical device company, today announced it received a Notice of Award, for a Fast Track Small Business Innovation Research (SBIR) grant, from the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH). Phase I of the project is budgeted in the amount of $600,000, with $3 Million budgeted for Phase II...

Delcath Announces Reimbursement for Chemosat in Germany

February 4, 2013 6:36 am | by The Associated Press | News | Comments

Delcath Systems, Inc. (NASDAQ: DCTH) today announced that the Institut für das Entgeltsystem im Krankenhaus (InEk), the German federal reimbursement agency, has established a reimbursement pathway for the treatment of patients with liver metastases with the Delcath Hepatic CHEMOSAT® Delivery System for melphalan hydrochloride.

GE Healthcare Works to Speed Up Fight Against Cancer

February 4, 2013 4:00 am | by The Associated Press | News | Comments

GE Healthcare’s work to accelerate cancer innovation and improve care for cancer patients reached new milestones in advanced technology. The campaign is founded on GE Healthcare’s integrated portfolio, which is uniquely positioned to drive impact in oncology and a leap forward for individualized cancer care.

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South Tees Hospitals NHS Foundation Trust Adopts Medworxx’ Patient Flow Solution

February 4, 2013 3:00 am | by The Associated Press | News | Comments

Medworxx Solutions Inc. announced South Tees Hospitals NHS Foundation Trust as its newest UK client, having licensed the Medworxx Patient Flow solution. They join The Royal Liverpool and Broadgreen University Hospitals NHS Trust who were the first to adopt the Medworxx solution in the UK, and have been recognized with the 2012 EHI award in the category of Outstanding Work in IT-enabled Change in Healthcare.

Elekta’s New Radiation Oncology Technology to Shape the Future of Cancer Care

February 4, 2013 1:46 am | by The Associated Press | News | Comments

At an exclusive event scheduled March 1, 2013, Elekta will reveal a leap forward in radiation oncology and the care of individuals with cancer worldwide. Founded in 1972, Elekta was the first to bring a completely digital linear accelerator to the market, as well as the first to fully integrate imaging technology in the treatment system. Elekta is a market-leading developer of cancer care and neuroscience solutions...

FDAnews Announces Clinical Quality Assurance Workshop

February 2, 2013 11:07 am | by Bio-Medicine.Org | News | Comments

Now you can learn how to FDA-proof your CQA audits … eliminate costly mistakes … and avoid FDA warning letters that say: "You failed to obtain and document that valid informed consent was obtained for each of the subjects enrolled in the study as required by stated regulations."

Medical device makers face another tax fight in Puerto Rico

February 1, 2013 5:57 pm | by Mass Device | News | Comments

Medical device maker have a new tax to worry about as Puerto Rico extends back down from a medical device tax increase expected for 2016. Puerto Rico officials backed down from a reduction in the country's medical device tax, planning instead to extend a temporary increase for another year. The 4% tax, originally imposed in 2010, was supposed to shrink each year and drop to 1% in 2016.

Watching Fish Thoughts Form

February 1, 2013 4:14 pm | by Massachusetts Institute of Technology | News | Comments

Scientists record the neuronal activity of a fish brain as the animal watches its prey. Scientists in Japan have recorded the neuronal activity of a fish as it eyes its dinner, the first live recording of the brain processes behind a natural behavior. The study was published online in Current Biology on Thursday.

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AdvaMed: More Competitive Bidding Compromises Patient Access

February 1, 2013 3:54 pm | by Mass Device | News | Comments

Medical device industry lobby AdvaMed warns that expanded competitive bidding programs may prevent patients from access to their preferred medical devices. Medical device industry lobbying group AdvaMed spoke out against an expansion to Medicare's competitive bidding programs, warning that the changes may deprive patients of their preferred devices.

Edap TMS asks FDA to OK Ablatherm prostate treatment

February 1, 2013 3:52 pm | by Mass Device | News | Comments

French medical device company Edap TMS asks the FDA for pre-market approval of its Ablatherm treatment for prostate cancer. EDAP (NSDQ:EDAP) said it filed for pre-market approval of its Ablatherm-HIFU prostate cancer treatment from the FDA.

Bringing Critical Mass to the Movement to Repeal the Medical Device Excise Tax

February 1, 2013 2:37 pm | by Thomas Allen Malm | News | Comments

Strategy consultant and author, Thomas Allen Malm, is proposing a way to shift the burden of the medical device excise tax (MDET) that he says will open a new dialog and solve two problems at once. He understands the optimism of manufacturers and industry associations growing from the number of Representatives in Congress crossing party lines to support the repeal of the 2.3% tax...

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Nanomaterials Key to Developing Stronger Artificial Hearts

February 1, 2013 2:30 pm | by Brigham and Women's Hospital | News | Comments

On January 30, 2013 ACS Nano published a study by Ali Khademhosseini, PhD, MASc, a researcher in the division of biomedical engineering at Brigham and Women's Hospital, detailing the creation of innovative cardiac patches that utilize nanotechnology to enhance the conductivity of materials to induce cardiac tissue formation. Creation of these ultra-thin cardiac patches put medicine a step closer to durable, high-functioning artificial tissues that could be used to repair damaged hearts and other organs.

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Bioelectric Signals Can Be Used to Detect Early Cancer

February 1, 2013 2:27 pm | by Tufts University | News | Comments

Biologists at Tufts University School of Arts and Sciences have discovered a bioelectric signal that can identify cells that are likely to develop into tumors. The researchers also found that they could lower the incidence of cancerous cells by manipulating the electrical charge across cells' membranes.

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Updated HHS Mandate Continues Attack on Religious Freedom

February 1, 2013 2:25 pm | by Bio-Medicine.Org | News | Comments

WASHINGTON , Feb. 1, 2013 /PRNewswire-USNewswire/ -- Responding to a new proposed regulation today by the U.S. Department of Health and Human Services (HHS), the Family Research Council (FRC) expressed strong opposition to HHS and the Obama administration's continued violation of religious freedom through its "contraceptive mandate."

GE Healthcare announces Class I recall of infant resuscitation kits

February 1, 2013 2:25 pm | by Mass Device | News | Comments

Healthcare giant GE recalls a resuscitation upgrade kit installed in certain infant warmers over concerns that mix-ups in labeling could lead to significant harm. The FDA gave Class I status to GE Healthcare's (NYSE:GE) recall of upgrade kits for some infant warmers over concerns that mislabeling in the kits may result in neonatal patients getting the wrong oxygen concentrations.

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