Abbott today announced the U.S. Food and Drug Administration (FDA) approved the Masters HP™ 15mm rotatable mechanical heart valve, the world’s smallest mechanical heart valve, that will allow doctors to treat babies and toddlers in need of a mitral or aortic valve replacement. Until today, surgeons could only use a range of larger-sized valves to replace a pediatric heart valve that could not be repaired, and larger valves are often not suitable given the smaller size of children’s hearts. This dime-sized new valve is the first and only pediatric mechanical heart valve developed for newborns and infants, and offers hope for pediatric patients in urgent need of treatment who have no other approved options.
To view the multimedia release go to:
https://www.multivu.com/players/English/8280551-abbott-pediatric-heart-valve-fda-approval/
Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, announced the U.S. Food and Drug Administration (FDA) approval and launch of the Cochlear™ Nucleus® Hybrid Implant System, a revolutionary new hybrid hearing solution that helps people who may hear a little but are still missing a lot, even with their hearing aids. The Nucleus Hybrid System is a unique combination of proven solutions, which allows people to get back what they've been missing by amplifying the low-pitched hearing a person does have while restoring access to the high-pitched hearing they've lost. People who are candidates for the technology no longer have to worry about straining to hear with their hearing aids as the Nucleus Hybrid System will allow them to maximize their hearing in all frequencies.
To view the Multimedia News Release, go to http://www.multivu.com/mnr/7150651-cochlear-fda-approval-u-s-launch-cochlear-nucleus-hybrid-implant-system
The U.S. Food and Drug Administration (FDA) is alerting pregnant women about the risks of listeriosis, a foodborne disease that can severely affect a pregnant women and her unborn child.
Listeria can affect all races and ethnic groups, but pregnant women are 10 times more likely than other healthy adults to get listeriosis due to hormonal changes that affect the immune system during pregnancy. Pregnant Hispanic women are about 24 times more likely than the general population to get listeriosis. A pregnant mother may pass Listeria onto her unborn baby without even knowing it because she doesn’t feel sick at all, yet the disease can lead to miscarriage, stillbirth, premature labor, the delivery of a low birthweight infant, a wide range of health problems for a newborn, or even infant death.
To view the multimedia release go to:
https://www.multivu.com/players/English/7953451-fda-listeriosis-prevention-pregnant-women/
Dornier MedTech® America, a global medical device company and the pioneer of Extracorporeal Shock Wave Lithotripsy (ESWL®), has received FDA clearance to market the Delta® III. This is the latest generation of the world’s best-selling and most clinically cited lithotripter, the Delta II.
To view the multimedia release go to:
https://www.multivu.com/players/English/8134451-dornier-medtech-delta-iii-kidney-stone-lithotripter/
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/
To help kids make healthful dietary choices, the U.S. Food and Drug Administration encourages kids to Read the Label!
The Nutrition Facts Label is a simple tool available on food and beverage packages. It lets kids know exactly what they’re eating and helps them choose and compare snacks and other foods. The earlier they start using the Nutrition Facts Label, the sooner they’ll be making choices that keep them feeling great and promote long-term good health!
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7106353-fda-national-childhood-obesity-month/
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced it has received U.S. Food and Drug Administration (FDA) clearance for the ClearSight system.
The ClearSight system is a noninvasive monitor that provides clinicians access to valuable blood volume and blood flow information for patients at moderate or high risk of post-surgical complications, in whom invasive monitoring would not be used.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7256451-edwards-fda-clearance-for-noninvasive-hemodynamic-monitoring-system/
Novartis announced today that the US Food and Drug Administration (FDA) has approved Jadenu™ (deferasirox) tablets, a new oral formulation of Exjade® (deferasirox) tablets for oral suspension, for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older, and chronic iron overload in non-transfusion-dependent thalassemia syndromes (NTDT) in patients 10 years of age and older. Jadenu is the only once-daily oral iron chelator that can be swallowed whole.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7440151-novartis-jadenu-fda-approval/
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/
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
Federally funded research continues to spur progress against cancer; however, accelerating the pace of progress will require robust, sustained, and predictable annual funding increases for the National Institutes of Health (NIH), the National Cancer Institute (NCI), and the Food and Drug Administration (FDA). Additionally, strong financial support for the National Cancer Moonshot Initiative is required, according to the sixth annual American Association for Cancer Research (AACR) Cancer Progress Report, released today.
One of the most exciting new approaches to cancer treatment is cancer immunotherapy. As detailed in the report, the utility of immunotherapy is expanding rapidly. For example, on Aug. 1, 2015, one class of immunotherapeutics, checkpoint inhibitors, was initially approved for just two types of cancer—melanoma and lung cancer. As of Sept. 1, 2016, checkpoint inhibitors have been approved for treating six types of cancer—bladder cancer, head and neck cancer, Hodgkin lymphoma, kidney cancer, lung cancer, and melanoma.
To view the multimedia release go to:
http://www.multivu.com/players/English/7911951-aacr-2016-cancer-progress-report/
Nearly three in four American voters (74 percent) favor increasing federal funding for cancer research, according to the results of a new national survey conducted on behalf of the American Association for Cancer Research (AACR). The survey results were released today in conjunction with the AACR’s fifth annual Cancer Progress Report. The report highlights how federally funded research can power progress against cancer and urges Congress and the administration to implement a strategy for providing annual budget increases of at least 7 percent for the National Institutes of Health (NIH), National Cancer Institute (NCI), and U.S. Food and Drug Administration (FDA) in fiscal year 2016 and thereafter.
The national survey, which was conducted by Hart Research Associates and Public Opinion Strategies, shows that five out of every six voters recognize what the AACR Cancer Progress Report 2015 details: that progress is being made against cancer.
To view the multimedia release go to:
http://www.multivu.com/players/English/7613551-aacr-cancer-research-survey/
