Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, introduces today its latest innovation, the Cochlear™ Nucleus® 7 Sound Processor. Approved by the U.S. Food and Drug Administration (FDA) in June, the Nucleus 7 Sound Processor is the world’s first Made for iPhone cochlear implant sound processor and the smallest and lightest behind-the-ear cochlear implant sound processor available on the market.1-3
With the Nucleus 7 Sound Processor, people with a Cochlear Nucleus Implant can now stream sound directly from a compatible iPhone, iPad and iPod touch directly to their sound processor.4,5* They will also be able to control, monitor and customize their hearing on their iPhone or iPod touch through the Nucleus® Smart App available to download for free from the App Store®.
To view the multimedia release go to:
https://www.multivu.com/players/English/7987851-cochlear-nucleus-7-sound-processor/
Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that its first doses of the Fluzone® (Influenza Vaccine) portfolio for the 2017-2018 influenza (“flu”) season have been released by the U.S. Food and Drug Administration (FDA). Sanofi Pasteur has begun distributing initial shipments, representing the first of nearly 70 million total doses of seasonal influenza vaccine manufactured by the company for this upcoming influenza season. Widespread shipment of Fluzone Quadrivalent, Fluzone High-Dose and Fluzone Intradermal Quadrivalent vaccine to health care provider offices, pharmacies and other immunizers will begin in early August to support fall immunization campaigns.
“As we enter the Swiftwater site’s 120th year, it reminds us of our innovation and growth as we came to understand the science of influenza and its impact on human health,” said David P. Greenberg, M.D., Associate Vice President and Regional Medical Head North America, Sanofi Pasteur. “Influenza can be especially severe for the most vulnerable populations, including the elderly, young children and those with compromised immune systems; however, it can also have a serious health impact on otherwise healthy individuals. Sanofi Pasteur is and always has been deeply committed to improving public health by continuously striving to develop new vaccines and on improving existing ones.”
To view the multimedia release go to:
https://www.multivu.com/players/English/8081151-sanofi-pasteur-influenza-vaccine-first-shipment-2017/
Nearly 12 million men in the U.S. suffer from symptoms related to benign prostatic hyperplasia (BPH), an enlargement of the prostate that can cause issues such as frequent and weak urinary streams and sleep deprivation from getting up repeatedly during the night to urinate. Since traditional BPH therapies such as daily medications and more invasive or surgical procedures often result in unwanted side effects and complications, more than 54 percent of men who would benefit from treating their BPH choose not to do anything1. With today’s national introduction of the FDA-cleared Rezūm® System, NxThera provides urologists and their patients suffering from symptomatic BPH with a new, safe and effective minimally-invasive, office-based treatment option which improves quality of life and preserves sexual function2 – one of the main reasons many men choose to forego medications or more invasive procedures.
“Men suffering from BPH are constantly evaluating the trade-offs between maintaining their current declined quality of life or treating their BPH symptoms and possibly incurring long term side effects,” said Dr. Kia Michel, M.D., a urologist at Comprehensive Urology in Los Angeles who recently performed the procedure as part of a nationally televised segment on prostate health. “Of all the minimally-invasive BPH treatments I’ve performed, Rezūm is the most effective and most versatile treatment available to patients – and the results have been excellent.”
To view the multimedia release go to:
http://www.multivu.com/players/English/7933151-nxthera-rezum-therapy/
Boston Scientific Corporation (NYSE:BSX) announces U.S. Food and Drug Administration (FDA) approval for the PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System, the Company’s next-generation drug-eluting stent (DES) technology. The PROMUS Element Stent, designed to provide physicians improved DES performance in treating patients with coronary artery disease, is built on an innovative platinum chromium (PtCr) platform with the market-leading everolimus drug. The Company plans to begin marketing the product in the U.S. immediately.
To view Multimedia News Release, go to http://www.multivu.com/mnr/43510-boston-scientific-fda-promus-element-plus-platinum-chromium-stent-system
Smith & Nephew plc (LSE: SN, NYSE: SNN), the global medical technology business, announces the FDA clearance of the pocket-sized PICO◊ system, a single use Negative Pressure Wound Therapy (NPWT) system. PICO is cleared for use both in a hospital and homecare setting and expands the use of NPWT from the traditional wound care population to include a wider range of patients undergoing orthopaedic surgery, plastic surgery and general surgical procedures. This FDA clearance follows the recent successful launch of PICO in Europe, Canada, and Australia.
To view Multimedia News Release, go to http://www.multivu.com/mnr/51011-smith-nephew-pico-system-fda-approval-npwt
FDA’s Read the Label Youth Outreach Campaign is an exciting initiative that challenges kids (ages 9 to 13) to “get their food facts first” by using the Nutrition Facts Label to make healthy food choices. Read the Label campaign materials enable parents and caregivers to help kids use this important tool.
To view the Multimedia News Release, go to http://www.multivu.com/mnr/7106352-fda-read-the-label-youth-outreach-campaign-tweens-healthy-choices
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/
