InSightec Ltd, the leader in magnetic resonance imaging (MRI)-guided Focused Ultrasound therapy, announced that the U.S. Food and Drug Administration (FDA) has approved ExAblate® MRI-guided focused ultrasound as a therapy to treat pain from bone metastases in patients who do not respond or cannot undergo radiation treatment for their pain. This is the second FDA approval for ExAblate, which has been used widely since it was approved in 2004 as a non-invasive, outpatient, therapy for uterine fibroids.
To view Multimedia News Release, go to http://www.multivu.com/mnr/56632-insightec-fda-approves-exablate
Using a combination of 160 high-resolution tungsten leaves and dramatically faster leaf movement, Elekta’s revolutionary new Agility™* MLC promises a new level of precision and delivery speed in radiation therapy treatments for cancer patients. Elekta recently received 510(k) clearance (K121328) from the U.S. Food and Drug Administration (FDA) for Agility, enabling U.S. medical centers to provide these clinical benefits to their patients with cancer.
To view Multimedia News Release, go to http://www.multivu.com/mnr/55638-elekta-agility-radiation-therapy-radiotherapy-cancer-sbrt
ACCU-CHEK Aviva Expert offers people with diabetes a new and easy way to simplify complex calculations to deliver precise insulin dosing advice.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the ACCU-CHEK® Aviva Expert system, the first and only blood glucose meter system with a built-in insulin calculator to be approved by the U.S. Food and Drug Administration (FDA), is now available by prescription. The device represents a significant advancement in blood glucose meter technology for people with diabetes who take multiple daily insulin injections. The meter’s integrated bolus calculator provides easy-to-use and reliable dose recommendations based on automated calculations, eliminating the need for manual dosing calculations and estimations.
To view the Multimedia News Release, go to: http://www.multivu.com/players/English/7322751-roche-accu-chek-aviva-expert-blood-glucose-meter-now-available/
In recognition of Melanoma Monday® and National Melanoma/Skin Cancer Detection & Prevention MonthTM, MELA Sciences, Inc. (NASDAQ: MELA) visited the NASDAQ MarketSite in Times Square today to ring the Opening Bell and sponsor free skin cancer checks.
One American dies every hour from melanoma, the most deadly skin cancer. MELA Sciences, Inc. is the pioneer company behind MelaFind®, the first and only FDA-approved diagnostic tool that helps dermatologists detect melanoma at its most curable stage. MelaFind® was approved by the U.S. Food & Drug Administration (FDA) in Fall 2011, and since then has strategically rolled out the technology to dermatology practices across the country.
To view Multimedia News Release, go to http://www.multivu.com/mnr/61584-mela-sciences-rings-opening-bell-awareness-melanoma-detection-prevention
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 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/
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
Allergan, Inc. (NYSE: AGN), the makers of LATISSE® (bimatoprost ophthalmic solution) 0.03%, announced today the launch of the LATISSE® Wishes Challenge campaign. Inspired by the tradition of blowing on an eyelash to make wishes come true, lifestyle designer Kathy Ireland, professional ballroom dancer Chelsie Hightower and style guide Bobbie Thomas will each lead teams of LATISSE® users from across the country who are challenged to raise more than a quarter of a million dollars for the Make-A-Wish Foundation, a nonprofit organization dedicated to granting the wishes of children with life-threatening medical conditions. LATISSE® solution is the first and only prescription treatment approved by the U.S. Food and Drug Administration (FDA) to grow lashes longer, fuller and darker for those with inadequate or not enough lashes (eyelash hypotrichosis).
To view Multimedia News Release, go to http://multivu.prnewswire.com/mnr/latisse/43354/
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/
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/
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
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/
