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/
According to a national study released today, moms are feeling overwhelming pressure to overspend on products for their babies even as they significantly cut back in nearly every other area of their lives to cope with these challenging times.
To view Multimedia News Release, go to http://www.multivu.com/mnr/54418-kelton-research-mom-study-baby-products-store-brand-infant-formula
The millions of women who experience bladder leakage now have a new option to strengthen and tone away their problem instead of covering it up with pads.
The PeriCoach System is a discreet device and smartphone app that helps women perform at-home pelvic floor muscle training, exercises recommended by the American College of Physicians as first-line treatment for urinary incontinence. PeriCoach is the only system that includes a web portal allowing clinicians to remotely monitor their patients’ progress.
To view the Multimedia News Release, go http://www.multivu.com/players/English/7543451-pericoach-fda-approval/
Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s antibacterial drug DIFICID™ (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhea (CDAD) in adults 18 years of age and older. CDAD is a significant medical problem in hospitals and long-term care facilities, and is beginning to emerge in the community among people previously at low risk for the disease. In the largest Phase 3 clinical studies ever conducted in CDAD, DIFICID had clinical response rates at the end of treatment that were non-inferior to oral vancomycin. DIFICID was superior to vancomycin in sustaining clinical response through 25 days beyond the end of treatment. DIFICID is the only FDA-approved antibacterial drug proven to be superior to vancomycin in sustained clinical response for CDAD.
To view Multimedia News Release, go to http://multivu.prnewswire.com/mnr/optimerpharma/50177/
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
Corindus Vascular Robotics, a leading developer of precision vascular robotics, today announced FDA 510(k) clearance has been granted for the CorPath 200 System to be used in percutaneous coronary interventions (PCI). The technology is now approved in the United States to assist interventional cardiologists in performing PCI, a procedure to restore blood flow to blocked arteries in patients with coronary artery disease (CAD).
“We are pleased to have received clearance from the FDA for the world’s first system designed for robotic-assisted PCI procedures,” said David M. Handler, President and CEO of Corindus Vascular Robotics. “This is an important milestone for interventional cardiology as we take the next step in transforming the way these procedures are performed in the future. The CorPath System offers hospitals the opportunity to bring robotic-assisted technology benefits to their coronary patients and their physicians.”
To view Multimedia News Release, go to http://www.multivu.com/mnr/57343-corindus-vascular-robotics-wins-fda-510k-clearance-for-corpath-200-system
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/
