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
Dune Medical Devices, Inc., announced today that its breakthrough intra-operative tissue assessment tool for early-stage breast cancer surgery, the MarginProbe System, has received Premarket Approval (PMA) by the United States Food and Drug Administration. The technology significantly improves surgeons’ ability to intra-operatively identify
More than 46 million turkeys will be cooked this Thanksgiving holiday, according to the National Turkey Federation. In an effort to help protect Americans from foodborne illness during the Thanksgiving season, the Ad Council, the U.S. Department of Agriculture (USDA)’s Food Safety and Inspection Service, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), in partnership with Food Network Star’s Martie Duncan, are helping to dispel many of the common myths surrounding the preparation and serving of the holiday turkey meal.
To view Multimedia News Release, go to http://www.multivu.com/mnr/59193-ad-council-usda-hhs-food-safe-families-public-service-thanksgiving
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
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
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
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
February is American Heart Month, and consumers should be aware that a high-sodium diet can increase their risk of developing high blood pressure. An estimated one in three Americans suffer from high blood pressure, which can increase the risk of developing cardiovascular disease – the leading cause of death in men and women in the United States.
To view the Multimedia News Release, go to http://www.multivu.com/mnr/65492-u-s-fda-reduce-sodium-intake-by-using-the-nutrition-facts-label
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
Since ancient times, the egg has been regarded as a symbol of new life and has been associated with springtime celebrations, such as Easter and Passover. But, even during festive occasions, eggs can cause food poisoning (also called foodborne illness) if they are not handled properly. That’s why the U.S. Food and Drug Administration (FDA) reminds consumers to handle fresh eggs safely during their springtime celebrations and throughout the year.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7231951-u-s-fda-egg-safety/
Hologic, Inc. (NASDAQ: HOLX) is kicking off Breast Cancer Awareness Month with the announcement that the Company's groundbreaking 3D mammography exam, available on the Selenia Dimensions platform, will be introduced to consumers today as Genius 3D Mammography. Hologic’s Genius 3D Mammography is the only 3D exam approved by the FDA as clinically superior to traditional mammography.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7254155-hologic-new-consumer-awareness-campaign-mammography-technology/
Teaming up with the American Diabetes Association® and the multi-talented performer and caretaker Joey Fatone @RealJoeyFatone, Colgate Total® is using the power of laughter to help raise awareness of the potential link between oral health and diabetes with the new “30 Days of Laughter” campaign (#30DaysofLOL), beginning today. The 30 days from November 12 to December 11, 2015 will be filled with laugh-out-loud videos, funny social media posts, engaging apps and more to make the diabetes community laugh, all while building awareness of the importance of maintaining the health of the teeth and gums behinds those smiles.
According to the Centers for Disease Control and Prevention, people with diabetes are two times more likely to develop gum disease1. Colgate Total® toothpaste can help prevent and even reverse gingivitis, the most common form of gum disease. It is the only FDA-approved and American Dental Association-accepted2 toothpaste to help prevent gingivitis. With regular twice daily brushing, you can help improve your gum health in as little as four weeks3 with Colgate Total®.
Understanding how challenging managing diabetes can sometimes be, the funny and talented performer Joey Fatone is leading the “30 Days of Laughter” campaign to remind people that sometimes laughter can feel like the best medicine. “When my father was diagnosed with Type 2 diabetes, our family was shocked. But we’re a big, loving group and we all help him together every day. I know that humor in the face of challenges is vital and I’m excited to share that with other families touched by diabetes.”
To view the multimedia release go to:
http://www.multivu.com/players/English/7654951-colgate-30-days-of-laughter/
