BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announced today that it received 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA) for the BD Veritor™ System for rapid detection of Flu A+B. This is the first rapid influenza test system that incorporates a digital read out of results to receive CLIA waiver.
To view Multimedia News Release, go to http://www.multivu.com/mnr/53615-bd-veritor-system-influenza-test-receives-510k-clearance-fda-clia-waiver
Children’s Memorial Hermann Hospital and Cord Blood Registry® (CBR) are launching the first FDA-approved, Phase I safety study on the use of cord blood stem cells to treat children with sensorineural hearing loss.
To view Multimedia News Release, go to http://www.multivu.com/mnr/53686-cord-blood-childrens-memorial-hermann-fda-approved-stem-cells-hearing-loss
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
In preparation for July 4th and the summer months when instances of food poisoning increase, the Ad Council and the U.S. Department of Agriculture’s Food Safety and Inspection Service, in partnership with the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), are continuing their national Food Safe Families public service campaign, the first multimedia effort designed to raise awareness of the risks of foodborne illness (or food poisoning) in the home.
To view Multimedia News Release, go to http://www.multivu.com/mnr/56338-ad-council-usda-hhs-food-safe-families-public-service-campaign
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
Sutter Neuroscience Institute, a recognized Center of Excellence, and CBR (Cord Blood Registry), the world’s largest stem cell bank, are launching the first FDA- approved clinical trial to assess the use of a child’s own cord blood stem cells to treat select patients with autism. This first-of-its-kind placebo controlled study will evaluate the ability of an infusion of cord blood stem cells to help improve language and behavior. The study is in conjunction with the Sutter Institute for Medical Research.
To view Multimedia News Release, go to http://www.multivu.com/mnr/57707-cord-blood-registry-stem-cell-trials-child-autism
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
More than 46 million turkeys will be cooked this Thanksgiving holiday, according to the National Turkey Federation. In an effort to help protect Americans from foodborne illness during the Thanksgiving season, the Ad Council, the U.S. Department of Agriculture (USDA)’s Food Safety and Inspection Service, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), in partnership with Food Network Star’s Martie Duncan, are helping to dispel many of the common myths surrounding the preparation and serving of the holiday turkey meal.
To view Multimedia News Release, go to http://www.multivu.com/mnr/59193-ad-council-usda-hhs-food-safe-families-public-service-thanksgiving
The egg has been associated with festivals celebrating spring for many centuries. Decorating eggs for Easter is a tradition that dates back to the 13th century or earlier. Eggs were formerly a forbidden food during the Lenten season, and there are rituals in many countries involving painting and decorating them to mark the end of the period of penance and fasting, and then eating them as a celebration of Easter.
To view Multimedia News Release, go to http://www.multivu.com/mnr/54146-u-s-fda-playing-it-safe-with-eggs-food-safety-tips
In a revolutionary treatment for early-onset scoliosis (EOS), a team of surgeons implanted adjustable growing rods in two children from California. The pioneering surgeries — the first ever in the United States — were performed on May 7th at Rady Children’s Hospital in San Diego. The Food and Drug Administration (FDA) granted Compassionate Use approval to use the MAGEC™ (MAGnetic Expansion Control) System, developed by Ellipse Technologies, Inc., for these two patients.
To view Multimedia News Release, go to http://www.multivu.com/mnr/61604-rady-children-s-hospital-san-diego-ellipse-magec-early-onset-scoliosis-eos
Diabetes experts met and determined that some self-monitoring blood glucose (SMBG) systems, despite meeting accuracy standards at the time of U.S. Food and Drug Administration (FDA) clearance, fail to consistently meet accuracy standards once on the market, potentially putting patient health at risk. In a public meeting convened by the Diabetes Technology Society on May 21, 2013, in Arlington, Virginia, leading academic clinicians, clinical chemists, medical device experts, patient advocates and FDA representatives reviewed a growing body of peer-reviewed research demonstrating that the performance of some blood glucose monitors on the market may not be meeting accuracy standards.
To view the Multimedia News Release, go to http://www.multivu.com/mnr/61870-diabetes-technology-society-inaccurate-blood-glucose-monitors-risky
Today, MedImmune Specialty Care division of AstraZeneca (MedImmune Specialty Care) announced it has joined with actress Tia Mowry to raise awareness about the importance of an annual flu vaccination. To kick-off the campaign, MedImmune Specialty Care and Mowry unveiled an online video, “I Insist!” (www.YouTube.com/InsistOnTheMist), which uses comedy to educate busy families about the importance of living a healthy lifestyle and making flu vaccination a priority. For Mowry, this includes vaccination with FluMistQuadrivalent, the first and only FDA-approved needle-free flu vaccine for eligible persons 2-49 years old. FluMist Quadrivalent is administered as a gentle mist sprayed into the nose, where the influenza virus usually enters the body.
To view Multimedia News Release, go to http://www.multivu.com/mnr/63079-medimmune-specialty-care-tia-mowry-flumist-quadrivalent-encourage-flu-shot
