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
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
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
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
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
Como preparación para el 4 julio y los meses veraniegos, período en el cual aumentan los casos de intoxicación alimentaria, el Ad Council y el Servicio de Inocuidad e Inspección de los Alimentos del Departamento de Agricultura de los Estados Unidos, en asociación con la Administración de Alimentos y Medicinas de los Estados Unidos (FDA) y los Centros para el Control y la Prevención de Enfermedades (CDC), prosiguen con su campaña de servicio público Familias Preparando Alimentos Adecuadamente a nivel nacional, el primer esfuerzo en multimedios diseñado para aumentar el grado de conciencia sobre los riesgos de las enfermedades transmitidas por los alimentos (o intoxicación alimentaria) en el hogar. Nuevos anuncios de servicio público (PSA), colocados en vallas, marquesinas de autobuses y otras localidades en exteriores a lo largo y ancho del país, están siendo distribuidos a medios informativos de todo el país y el spot televisivo “Chill” (Refrigere) se transmitirá a través de la cadena Checkout TV Network en 600 en tiendas de Walmart a nivel nacional.
To view Multimedia News Release, go to http://www.multivu.com/mnr/56942-ad-council-usda-hhs-food-safe-families-public-service-campaign
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
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
Gen-Probe (NASDAQ: GPRO) announced today the US Food and Drug Administration (FDA) has approved its PROGENSA® PCA3 (Prostate Cancer gene 3) assay, the first molecular test to help determine the need for repeat prostate biopsies in men who have had a previous negative biopsy.
To view Multimedia News Release, go to http://www.multivu.com/mnr/53530-gen-probe-progensa-pca3-prostate-cancer-psa
According to a national study released today, moms are feeling overwhelming pressure to overspend on products for their babies even as they significantly cut back in nearly every other area of their lives to cope with these challenging times.
To view Multimedia News Release, go to http://www.multivu.com/mnr/54418-kelton-research-mom-study-baby-products-store-brand-infant-formula
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
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