Jul28
NATICK, Mass., July 29 /PRNewswire-FirstCall/ Boston Scientific Corporation (NYSE: BSX) today announced U.S. Food and Drug Administration approval of two spinal cord stimulation (SCS) leads for use with its Precision Plus? Spinal Cord Stimulator System, the world's first rechargeable SCS device for the management of chronic pain of the trunk and/or limbs. The Linear? [...]
Jul28
SAN DIEGO, July 29 /PRNewswire-FirstCall/ Orexigen Therapeutics, Inc. (Nasdaq: OREX) announced that results from its COR-I trial of Contrave were published online today in the journal Lancet. COR-I was the largest of the four, 56-week, Phase 3 trials supporting the New Drug Application for Contrave, currently under review by the U.S. Food and Drug [...]
Jul27
Pitt County Memorial Hospital (PCMH) announced results of a study demonstrating that universal surveillance for methicillin-resistant Staphylococcus aureus (MRSA) decreased health care-associated infections (HAIs) related to devices. Infection rates decreased 68 percent for ventilator-associated pneumonias (VAP); 51 percent for central line-associated bacteremias (CLA-BSI); and 49 percent for catheter-associated urinary tract infections (CAUTI).The study was led [...]
Jul27
The U.S. Food and Drug Administration today required Baxter Healthcare Corp. to take specific steps to carry out the April 2010 recall of all Colleague Volumetric Infusion Pumps (CVIP) and to provide customers with a refund, a replacement pump, or lease termination (see also Infusion Pumps).Baxter is responsible for recalling as many as 200,000 CVIP [...]
Jul27
WASHINGTON The United States has filed a complaint under the False Claims Act against Dr. Najam Azmat and the Satilla Regional Medical Center in Waycross, Ga., the Justice Department announced today. The complaint, filed in U.S. District Court for the Southern District of Georgia, alleges that the defendants submitted false or fraudulent claims to [...]
Jul27
MARLBOROUGH, Mass.(BUSINESS WIRE) Advanced Cell Technology, Inc. (ACT?; OTCBB:ACTC) announced today that it has submitted documentation and a complete response to substantively address the issues raised by the US Food and Drug Administration (FDA) in [...]
Jul27
ABBOTT PARK, Ill., July 28 /PRNewswire-FirstCall/ Abbott (NYSE: ABT) today received U.S. Food and Drug Administration (FDA) approval for two new dosage strengths of SIMCOR, a cholesterol medication. The new SIMCOR dosage strengths combine 40 mg of simvastatin the most commonly prescribed dose of simvastatin with either 500 mg or 1,000 mg [...]
Jul27
SILVER SPRING, Md., July 28 /PRNewswire-USNewswire/ The U.S. Food and Drug Administration today approved Cuvposa (glycopyrrolate) Oral Solution to treat chronic severe drooling caused by neurologic disorders in children ages 3 years to 16 years.(Logo: (Logo: Drooling is normal in infants. But a significant proportion of the developmentally disabled population experiences drooling caused primarily by [...]
Jul27
To: HEALTH, MEDICAL, AND NATIONAL EDITORSContact: Elaine Gansz Bobo of the U.S. Food and Drug Administration, +1-301-796-7567, elaine.bobo@fda.hhs.gov, Consumer Inquiries: 888-INFO-FDASILVER SPRING, Md., July 28 /PRNewswire-USNewswire/ The U.S. Foodand Drug Administration today approved Cuvposa (glycopyrrolate) OralSolution to treat chronic severe drooling caused by neurologicdisorders in children ages 3 years to 16 years.(Logo: is [...]
Jul27
BOWIE, Md., July 28 /PRNewswire/ MedAssurant Inc., a leading provider of data-driven healthcare solutions, announced that research from a major study by America's Health Insurance Plans (AHIP) was presented in Washington D.C. today featuring MedAssurant's data and analytics. The results were presented by AHIP alongside executives from Aetna, Humana, Tufts and United in a [...]