Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, announces today it has received U.S. Food and Drug Administration (FDA) approval for its newest innovative hearing loss solution, Kanso.
The Kanso Sound Processor provides a distinct new way for cochlear implant users to hear. Unlike most hearing aids and current cochlear implant sound processors that are worn on the ear, Kanso is a small, off-the-ear hearing device that provides a more discreet hearing solution and delivers the same hearing experience as a behind-the-ear sound processor.
The name Kanso is a Japanese word for ‘simplicity,’ and it was selected in recognition of Kanso’s all-in-one design. The Kanso Sound Processor features a single on/off button with no cables so it is easy to use. It is worn on the user’s head with nothing behind the ear, adding greater comfort for those with glasses, and it can be easily hidden under or blended within a user’s hair.
To view the multimedia release go to:
http://www.multivu.com/players/English/7658352-cochlear-kanso-fda-approval/
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
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 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/
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
Boston Scientific (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval for the SYNERGY™ Bioabsorbable Polymer Drug-Eluting Stent System (BP-DES) for the treatment of coronary artery disease.
With this FDA approval, Boston Scientific will commence commercialization of the first and only BP-DES in the U.S. Notably, both the drug coating and the polymer – which modulates drug release – are fully absorbed shortly after drug elution is complete at three months.
The SYNERGY Stent provides synchronized drug and polymer absorption. It is designed to enable more rapid and complete arterial healing, and to thereby reduce the risk of complications associated with long-term polymer exposure compared to currently-used drug-eluting stents (DES) with permanent polymers.
To view the multimedia release go to:
http://www.multivu.com/players/English/7223456-boston-scientific-fda-approval-synergy/
The American Society for Aesthetic Plastic Surgery (ASAPS), is hosting a panel discussion about the latest best practices and uses for injectables including the newest FDA-approved options at The Aesthetic Meeting today in Montreal, Quebec Canada.
The panel discussed the latest advances, including the ways various dermal fillers can be utilized to produce optimal results for targeted areas. There are thirteen FDA-approved dermal fillers on the market to-date, providing aesthetic plastic surgeons with the ability to customize anti-aging treatments to patients’ needs. “The filler choices are dictated by a patient’s unique aging pattern, the anatomical area to be treated and physiochemical properties,” explains ASAPS member, Dr. Z. Paul Lorenc.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7310753-asaps-facial-rejuvenation-injectables/
EnteroMedics Inc. (NASDAQ: ETRM) today announced that the U.S. Food and Drug Administration (FDA) has approved VBLOC® vagal blocking therapy, delivered via the Maestro® System, for the treatment of adult patients with obesity who have a Body Mass Index (BMI) of at least 40 to 45 kg/m2, or a BMI of at least 35 to 39.9 kg/m2 with a related health condition such as high blood pressure or high cholesterol levels, and who have tried to lose weight in a supervised weight management program within the past five years. The Maestro System is the first new medical device to be approved by the FDA for obesity in over ten years. EnteroMedics anticipates that the device will be available, on a limited basis, at select Bariatric Centers of Excellence in the U.S. this year. The Maestro System has received CE Mark and is listed on the Australian Register of Therapeutic Goods.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7269351-enteromedics-fda-approval-vbloc-maestro-system-weight-loss-device/
The winter of 2016-2017 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 the multimedia release go to:
http://www.multivu.com/players/English/7876851-fda-power-outage-food-safety-2016/
La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) alerta a las mujeres embarazadas sobre los riesgos de la listeriosis, una enfermedad transmitida por los alimentos que puede afectar gravemente a las mujeres embarazadas y a sus bebés no nacidos.
La Listeria puede afectar a personas de todas las razas y grupos étnicos, pero las mujeres embarazadas tienen una probabilidad aproximadamente 10 veces mayor de contraer listeriosis que otros adultos sanos debido a los cambios hormonales que afectan el sistema inmunológico durante el embarazo. Las mujeres hispanas embarazadas son unas 24 veces más propensas a contraer listeriosis que la población general. Una mujer embarazada puede transmitir la Listeria a su bebé no nacido incluso sin saberlo porque no se siente enferma, pero la enfermedad puede provocar un aborto espontáneo, muerte fetal, parto prematuro, nacimiento de un bebé con bajo peso, una amplia gama de problemas de salud para el recién nacido o incluso la muerte del bebé.
To view the multimedia release go to:
https://www.multivu.com/players/Spanish/7953451-fda-listeriosis-prevention-pregnant-women/
1 in 3 women will notice hair thinning in her lifetime, and it can start as early as her 20’s. Today, the hair regrowth category leader, ROGAINE® Brand, announced the official launch to market of Women's ROGAINE® 5% Minoxidil Topical Aerosol, the first and only FDA-approved, once-daily use treatment for Female Pattern Hair Loss containing 5 percent minoxidil in an elegant foam formula. Minoxidil is the only topical ingredient FDA-approved to help regrow hair.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/7368851-introducing-women-s-rogaine-5-percent-minoxidil-topical-aerosol-fda-approved/
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/
