Exact Sciences Corp. (NASDAQ: EXAS) announced today that the U.S. Food and Drug Administration (FDA) has approved Cologuard, the company’s noninvasive, stool DNA colorectal cancer screening test. Cologuard is the first noninvasive screening test for colorectal cancer that analyzes both stool DNA and blood biomarkers and has been proven to find 92 percent of cancers and 69 percent of the most advanced precancerous polyps in average risk patients. Cologuard, which is available through healthcare providers, offers people 50 and older at average risk for colorectal cancer an easy–to–use screening test they can do in the privacy of their own home.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7092251-fda-approve-s-exact-sciences-cologuard-screening-test-colorectal-cancer/
Following the unprecedented Gore REDUCE Clinical Study conclusion that closure of patent foramen ovale (PFO) can prevent recurrent ischemic strokes, W. L. Gore & Associates, Inc. (Gore) has received approval from the U.S. Food and Drug Administration (FDA) for an expanded indication for its GORE® CARDIOFORM Septal Occluder. The device, already approved for closure of atrial septal defects (ASDs) up to 17 mm, is now also approved for the closure of PFO to reduce the risk of recurrent ischemic stroke in certain patients.*
To view the multimedia release go to:
https://www.multivu.com/players/English/8301551-gore-cardioform-septal-occluder-fda-approval/
Studies show that more than two-thirds of aesthetically-oriented consumers are bothered by submental fullness, or “double chin.” And with social media profile images becoming more important than ever, there is interest in looking one’s best.
Submental fullness due to fat beneath the chin can impact a broad range of both men and women and because the condition can be genetic and resistant to diet and exercise. But there’s KYBELLA®, the first and only FDA-approved injectable treatment that is available by prescription only, that has been proven to improve the appearance of moderate to severe fat beneath the chin by physically destroying fat cells in the treatment area. In two pivotal clinical studies for KYBELLA®, reductions in submental fat volume were observed more frequently in the KYBELLA® treated group of 514 patients compared to the placebo group (508 patients) as measured by both clinician and patient ratings. In addition, visual and emotional impacts of submental fat (happy, bothered, self-conscious, embarrassed, looking older or overweight) were evaluated using a 6-question survey and 79% of 1 and 2-grade composite responders reported satisfaction after 12 weeks post final treatment compared with 33.6% of patients who received placebo.
To view the multimedia release go to:
http://www.multivu.com/players/English/7962051-kybella-injectable-double-chin-treatment-campaign/
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
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
October is National Seafood Month and a time to highlight the importance of fish and shellfish as part of a healthful diet. As with any food, safe handling of seafood is essential to reducing the risk of foodborne illness (often called food poisoning).
Learn more at:
http://www.fda.gov/Food/FoodborneIllnessContaminants/BuyStoreServeSafeFood/ucm077331.htm
Fresh and Frozen Seafood: Selecting and Serving it Safely
The U.S. Food and Drug Administration (FDA) reminds you to follow these basic safety tips for buying, storing, and preparing fish and shellfish.
To view the multimedia release go to:
http://www.multivu.com/players/English/7594351-fda-seafood-safety/
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
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Eisai Inc. today announced the launch of a new national television advertising campaign for BELVIQ® (lorcaserin HCl) CIV, an FDA-approved prescription therapy for chronic weight management. The advertisement will air on numerous channels including Lifetime, Oxygen and AMC.
The spot illustrates the struggles many people face when they are trying to lose or control their weight. BELVIQ is presented as a targeted approach to weight loss, that, when combined with diet and increased activity, may help some patients lose weight and keep it off.
To view the Multimedia News Release, go to http://www.multivu.com/mnr/7161051-eisai-launches-national-television-campaign-belviq-lorcaserin-hcl-civ
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announced today that it received 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA) for the BD Veritor™ System for rapid detection of Flu A+B. This is the first rapid influenza test system that incorporates a digital read out of results to receive CLIA waiver.
To view Multimedia News Release, go to http://www.multivu.com/mnr/53615-bd-veritor-system-influenza-test-receives-510k-clearance-fda-clia-waiver
The egg has been regarded as a symbol of new life and has been associated with springtime celebrations, such as Easter and Passover, for many centuries. But, even during festive occasions, eggs can cause food poisoning (also called foodborne illness). That’s why the U.S. Food and Drug Administration reminds consumers to follow safe food handling practices when buying, storing, preparing, and serving eggs or foods that contain them during their springtime celebrations and throughout the year.
To view the multimedia release go to:
http://www.multivu.com/players/English/7790251-fda-egg-safety/
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