The Alfred Mann Foundation (AMF) today announced the first subject, a U.S. Marine, SSgt James Sides, as a recipient of its highly anticipated IMES System (implantable myoelectric sensor) – an experimental system that holds the promise of being the first minimally invasive, intuitive, multi-channel control system for prosthetics intended for long term use. The IMES System is currently being studied under the Investigational Device Exemption (IDE) regulations of the U.S. Food and Drug Administration (FDA). AMF’s ongoing trial with injured veterans at the Walter Reed National Medical Military Center anticipates subjects intuitively operating three different prosthetic movements simultaneously: opening and closing the hand, rotating the wrist, and moving the thumb. Combining these three movements enables several grasps that are invaluable for performing everyday tasks.
To view the Multimedia News Release, go to http://www.multivu.com/mnr/65112-alfred-mann-foundation-u-s-marine-subject-fda-study-for-imes-system
The winter of 2014 is in its early stages, and yet many parts of the country are already experiencing extreme weather conditions and power outages. In fact, a power outage can happen at any time, and it can affect the safety of your food. The U.S. Food and Drug Administration reminds you that the best way to ensure that food stays safe is to have a plan in place, and to know what food safety precautions to take if a power outage does occur.
To view Multimedia News Release, go to http://www.multivu.com/mnr/64318-u-s-fda-food-safety-during-and-after-a-power-outage
In recent years there has been a shift in the understanding of cancer. Immunotherapy with vaccines has been emerging as the most promising direction towards a decisive improvement of treatment outcomes.
The Dendritic Cell Vaccine has received FDA approval for prostate cancer and trials are now under way for a variety of other cancers. These vaccines are usually administered on their own.
To view Multimedia News Release, go to http://www.multivu.com/mnr/64654-issels-integrative-immunotherapy-for-standard-therapy-resistant-cancers
Today, MedImmune Specialty Care division of AstraZeneca (MedImmune Specialty Care) announced it has joined with actress Tia Mowry to raise awareness about the importance of an annual flu vaccination. To kick-off the campaign, MedImmune Specialty Care and Mowry unveiled an online video, “I Insist!” (www.YouTube.com/InsistOnTheMist), which uses comedy to educate busy families about the importance of living a healthy lifestyle and making flu vaccination a priority. For Mowry, this includes vaccination with FluMistQuadrivalent, the first and only FDA-approved needle-free flu vaccine for eligible persons 2-49 years old. FluMist Quadrivalent is administered as a gentle mist sprayed into the nose, where the influenza virus usually enters the body.
To view Multimedia News Release, go to http://www.multivu.com/mnr/63079-medimmune-specialty-care-tia-mowry-flumist-quadrivalent-encourage-flu-shot
With their high quality protein and other essential nutrients, fish and shellfish are important parts of a healthful diet. But, as with any food, safe handling is essential to reducing the risk of foodborne illness, often called “food poisoning.” Follow these basic food safety tips for buying, storing, and preparing fish and shellfish.
To view the Multimedia News Release, go to http://www.multivu.com/mnr/54147-u-s-fda-safe-food-handling-tips-fish-shellfish-reduce-risk-food-poisoning
Diabetes experts met and determined that some self-monitoring blood glucose (SMBG) systems, despite meeting accuracy standards at the time of U.S. Food and Drug Administration (FDA) clearance, fail to consistently meet accuracy standards once on the market, potentially putting patient health at risk. In a public meeting convened by the Diabetes Technology Society on May 21, 2013, in Arlington, Virginia, leading academic clinicians, clinical chemists, medical device experts, patient advocates and FDA representatives reviewed a growing body of peer-reviewed research demonstrating that the performance of some blood glucose monitors on the market may not be meeting accuracy standards.
To view the Multimedia News Release, go to http://www.multivu.com/mnr/61870-diabetes-technology-society-inaccurate-blood-glucose-monitors-risky
In a revolutionary treatment for early-onset scoliosis (EOS), a team of surgeons implanted adjustable growing rods in two children from California. The pioneering surgeries — the first ever in the United States — were performed on May 7th at Rady Children’s Hospital in San Diego. The Food and Drug Administration (FDA) granted Compassionate Use approval to use the MAGEC™ (MAGnetic Expansion Control) System, developed by Ellipse Technologies, Inc., for these two patients.
To view Multimedia News Release, go to http://www.multivu.com/mnr/61604-rady-children-s-hospital-san-diego-ellipse-magec-early-onset-scoliosis-eos
In recognition of Melanoma Monday® and National Melanoma/Skin Cancer Detection & Prevention MonthTM, MELA Sciences, Inc. (NASDAQ: MELA) visited the NASDAQ MarketSite in Times Square today to ring the Opening Bell and sponsor free skin cancer checks.
One American dies every hour from melanoma, the most deadly skin cancer. MELA Sciences, Inc. is the pioneer company behind MelaFind®, the first and only FDA-approved diagnostic tool that helps dermatologists detect melanoma at its most curable stage. MelaFind® was approved by the U.S. Food & Drug Administration (FDA) in Fall 2011, and since then has strategically rolled out the technology to dermatology practices across the country.
To view Multimedia News Release, go to http://www.multivu.com/mnr/61584-mela-sciences-rings-opening-bell-awareness-melanoma-detection-prevention
Raptor Pharmaceutical Corp. (“Raptor” or the “Company”) (Nasdaq: RPTP), today announced that the U.S. Food and Drug Administration (FDA) has approved PROCYSBI™ (cysteamine bitartrate) delayed release capsules for the treatment of nephropathic cystinosis in adults and children 6 years and older. In a Phase 3 study, PROCYSBI showed consistent cystine depletion over the full 12-hour dosing period. Sustained levels of cysteamine have not historically been achieved in the majority of patients in this population. Studies have shown that sustained cystine depletion in patients may significantly delay disease progression, including kidney dysfunction, dialysis, kidney transplant, organ failure and premature death.
To view Multimedia News Release, go to http://www.multivu.com/mnr/61338-raptor-pharmaceutical-procysbi-fda-approval-nephropathic-cystinosis
The egg has been associated with festivals celebrating spring for many centuries. Decorating eggs for Easter is a tradition that dates back to the 13th century or earlier. Eggs were formerly a forbidden food during the Lenten season, and there are rituals in many countries involving painting and decorating them to mark the end of the period of penance and fasting, and then eating them as a celebration of Easter.
To view Multimedia News Release, go to http://www.multivu.com/mnr/54146-u-s-fda-playing-it-safe-with-eggs-food-safety-tips
For the millions who suffer from Gastroesophageal Reflux Disease (GERD), a study published today in the New England Journal of Medicine (NEJM) provides clinical evidence of safety and effectiveness for a new, FDA-approved medical device. Torax Medical’s LINX® Reflux Management System was studied in a controlled, prospective, multicenter trial involving 14 U.S. and European medical centers as part of the FDA pre-market approval process. The patients were evaluated before and after treatment to determine the effect of the LINX System on their GERD using pre-defined success criteria, which included reduction of esophageal acid, improvement in quality of life and elimination of reflux medications.
To view Multimedia News Release, go to http://www.multivu.com/mnr/60077-torax-medical-linx-reflux-management-system-clinical-study-published
