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Abbott announced today the U.S. Food and Drug Administration approval and launch of the iDesign Advanced WaveScan Studio System. The system acts as the "brain" of the LASIK procedure, generating a high-definition scan that measures and maps irregularities of the eye that may impact vision. From these measurements, the iDesign System creates an accurate and personalized LASIK treatment plan based on the unique "blueprint" of each person’s eyes.
The iDesign System captures more than 1,200 micro readings of the eye, as well as identifying the shape of the cornea, its curvature, how light passes through the eye and pupil diameter under different lighting conditions – all in one, three-second scan that can be used to precisely correct vision.
The development of the sensor technology within the iDesign System was the result of an earlier discovery by Abbott scientists, which NASA used to accurately measure and shape the mirrors in the James Webb Space Telescope to ensure it will transmit high resolution images of deep space back to earth. The telescope is scheduled to launch in 2018.
To view the Multimedia News Release, please go to http://www.multivu.com/players/English/7571951-abbott-idesign-system-3-d-eye-map/
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/
Janssen-Cilag International NV (Janssen) announced today that the European Commission has approved IMBRUVICA™ (ibrutinib) capsules, a first-in-class, once-daily, oral Bruton’s tyrosine kinase (BTK) inhibitor. This new approach to treating blood cancers works by blocking BTK, a protein that helps certain cancer cells live and grow.1 IMBRUVICA is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL), or adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.
To view the Multimedia News Release, go to http://www.multivu.com/players/English/72762540-janssen-ec-approval-imbruvica-mcl-cll/
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
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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/
The following is being released by the Notice Provider, Kinsella Media, LLC, about the lawsuit In re Automotive Parts Antitrust Litigation, MDL No. 2311.
There is an update for affected purchasers in this lawsuit about certain vehicle components, as there have been additional Settlements that may affect their rights.
Twelve additional Defendants have agreed to Settlements resolving claims that they fixed the price of certain vehicle components. (The Court previously approved settlements with 11 Defendants, totaling approximately $225 million.) The additional Settlements being presented for Court Approval total approximately $379 million.
The lawsuits allege that Defendants fixed the price of certain vehicle components, causing millions of consumers and businesses from around the country to pay more for certain new or leased vehicles and replacement parts. A complete list of included parts is available at the website, www.AutoPartsClass.com.
To view the multimedia release go to:
http://www.multivu.com/players/English/7982351-auto-parts-class-action-settlements/
Moncler S.p.A. announces that today it has obtained approval from CONSOB for the Prospectus for the Initial Public Offering issued for the purpose of the admission of the Company’s ordinary shares to trading on the Mercato Telematico Azionario organized and managed by Borsa Italiana S.p.A..
To view the Multimedia News Release, go to http://www.multivu.com/mnr/64154-Eurazeo-Moncler-IPO-clearance
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
