Posts Tagged ‘medical devices’


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  • A.M. Vitals: Pfizer and Novartis Drugs Get FDA Panel Recommendation

    Wednesday, April 13th, 2011 at 22:25 | Comments Off

    FDA Panel Votes: Kidney-cancer drugs made by Pfizer and Novartis have received a thumbs-up from an FDA advisory panel, bolstering their chances of gaining approval to also treat rare advanced pancreatic neuroendocrine tumors, the WSJ reports. The panel voted 10-0 on the question of whether the benefits of Novartis’s Afinitor outweighed the risks, and voted 8-2 on a similar question about using Pfizer’s Sutent for tumors that cannot be removed surgically. We have to say it: the ..read more

  • J&J Recall Watch: 360,000 surgical wound drainers

    Friday, March 25th, 2011 at 04:13 | Comments Off

    Johnson & Johnson announced another recall today, this time pulling about 360,000 products sold in the U.S. for use draining surgical wounds, Dow Jones Newswires reports.

    J&J’s Ethicon unit, which makes the Blake Silicone Drains, J-VAC reservoirs and other withdrawn products, says it hasn’t received any reports of side effects. The company said it decided to recall the devices after customers complained the sterile packaging could be compromised.

    The company blamed the problem on an unidentified contract manufacturer. Here’s the company’s letter ..read more

  • A.M. Vitals: J&J-FDA Tussle Highlights Medical Device Approval Debate

    Saturday, February 19th, 2011 at 00:44 | Comments Off

    Also: a quick guide to states’ planned Medicaid cuts; asking for clarification on health-care overhaul ruling; how to talk about cancer.

    Go here to read the rest:  A.M. Vitals: J&J-FDA Tussle Highlights Medical Device Approval Debate

  • AdvaMed-Sponsored Report Says Safety Not Improved By Longer Approval Process

    Saturday, January 29th, 2011 at 04:28 | Comments Off

    A new report shows that a slower regulatory process in the U.S. doesn’t result in fewer device recalls.

    Read the original: AdvaMed-Sponsored Report Says Safety Not Improved By Longer Approval Process

  • A.M. Vitals: Senate May Vote on Health-Care Law Repeal

    Tuesday, January 25th, 2011 at 00:09 | Comments Off

    Also: HHS announces fraud figures; Sanofi and Genzyme, still talking; an FDA panel weighs electroshock therapy.

    The rest is here:  A.M. Vitals: Senate May Vote on Health-Care Law Repeal

  • Will Medical Technology Innovation Shift to Emerging Markets?

    Wednesday, January 19th, 2011 at 09:12 | Comments Off

    The PwC report says that med tech innovators are increasingly going outside the U.S. “to seek clinical data, new-product registration and first revenue.”

    Excerpt from:  Will Medical Technology Innovation Shift to Emerging Markets?

  • The Top Ten Health Technology Threats to Patient Safety

    Thursday, December 9th, 2010 at 10:15 | Comments Off

    Radiation-therapy dose errors are the top tech health hazard, according to ECRI Institute.

    See original here:  The Top Ten Health Technology Threats to Patient Safety

  • Medtronic’s Ardian Purchase is a Bet on New Anti-Hypertension Tech

    Wednesday, November 24th, 2010 at 06:34 | Comments Off

    Boston Scientific has said the market could someday be as big as $5 billion.

    See more here:  Medtronic’s Ardian Purchase is a Bet on New Anti-Hypertension Tech

  • A.M. Vitals: Johnson & Johnson Recalls Kids’ Benadryl, Motrin

    Wednesday, November 24th, 2010 at 00:42 | Comments Off

    Also: radiation concerns over dental CT scanners; gap in oversight on medical device manufacturing; STD rates.

    Read more here:  A.M. Vitals: Johnson & Johnson Recalls Kids’ Benadryl, Motrin

  • FDA Medical Device Review Process: Too Fast or Too Slow?

    Saturday, November 20th, 2010 at 04:33 | Comments Off

    An industry-funded study finds devices were available in the U.S. “an average of two full years later” than in other countries.

    More:  FDA Medical Device Review Process: Too Fast or Too Slow?