Posts Tagged ‘FDA’

Daily Brief: Device Industry Supports Current Federal Approval Process

Friday, September 17th, 2010

FALLS CHURCH – Top medical and recall news headlines from Noblis Health Innovation for Friday, Sept. 17. Click on the underlined item for the actual link to the story:

  • Medical device industry touts safety of regulatory approval process: The industry group representing medical devices released a report on Wednesday that touts the safety of a federal approval process the Obama administration wants to overhaul.
  • Drug-resistant ‘superbugs’ hit 20 states, spread worldwide: Bacteria that are able to survive every modern antibiotic are cropping up in many U.S. hospitals and are spreading outside the country, public health officials say.
  • InformationWeek 500: Healthcare Innovators: InformationWeek 500 healthcare companies are using technology in innovative ways to improve care, including state-of-the-art mobile communications, a federated imaging system, and advanced wellness services. Get a look at 10 of them in this slide show.
  • Medical Radiation Countermeasure Moves Forward: Cleveland BioLabs, Inc. yesterday said that it was awarded a $45 million contract from the United States Department of Defense (DoD) Chemical Biological and Medical Systems (CBMS) Medical Identification and Treatment Systems (MITS) to develop and stockpile CBLB502 as a medical radiation countermeasure.

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Headlines: FDA Approves Therapy for Prostate Cancer

Thursday, April 29th, 2010

WASHINGTON, D.C. – The U.S. Food and Drug Administration today approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease.

Provenge is indicated for the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment. Prostate cancer is the second most common type of cancer among men in the United States, behind skin cancer, and usually occurs in older men. In 2009, an estimated 192,000 new cases of prostate cancer were diagnosed and about 27,000 men died from the disease, according to the National Cancer Institute. (more…)

Headlines: New Stent at GASTRO 2009, Lovato Loves Milk

Friday, November 20th, 2009

NATICK, Mass.Boston Scientific Corporation said that it has received 510(k) clearance from the U.S. Food and Drug Administration to market its WallFlex Fully Covered Esophageal Stent for the treatment of malignant esophageal obstructions caused by tumors.

The stent is part of the WallFlex Stent family of self-expanding metal stents which will be available for hands-on demonstration at the GASTRO 2009 conference, to be held November 21-25 in London.

Other news includes:

  • Cardinal Health and Patient Safety Technologies today announced that they have entered into a five-year distribution agreement to co-market the SurgiCount Safety-Sponge. The sponge has a counting system to help insure that sponges are not left in patients during surgery.
  • New York-based Medco Health Solutions, Inc has a new method patient-centric model that includes training pharmacists to counsel patients and coordinate care.
  • Teen singer and actress Demi Lovato is the lastest to be featured in the “Got Milk” campaign by the Milk Processor Education Program. The  “Got Milk” campaign is best known for adults, but the addition of Disney actress (and former Barney star) Lovato signals the program is concerned about milk usage in the teen and pre-teen markets.