FDA issues warning about fake versions of C.R. Bard surgical mesh

The Food & Drug Administration is warning healthcare providers to be on the lookout for fake surgical mesh products that ape C.R. Bard’s (NYSE:BCR) Davol Inc. brand, saying hospitals and surgical centers not to mention patients with surgical mesh implants should be especially vigilant.The federal watchdog agency said [...]

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Minnesota med tech on possible 510(k) overhaul: ‘We’re not gonna take it …’

“We’re not here to bash the FDA,” Mark DuVal, president of Minneapolis law firm DuVal & Associates, told a group of medical device executives and investors late Wednesday afternoon.Too late.The newly formed Minnesota Medical Device Alliance billed the gathering in the downtown Warehouse District as the first step to help save the Food and Drug [...]

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Ohio gets $19M in federal funds for health care job training

Four Ohio organizations will receive a total of $19 million in federal funding to train workers for jobs in the health care industry. The funding comes from last year’s federal stimulus act and will be distributed by the U.S. Department of Labor.

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FDA leader says agency must update clearance process for medical devices

Regulatory science must evolve along with advances in the life sciences, according to Food & Drug Administration commissioner Margaret Hamburg.

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FDA: warnings, recall for diagnostic equipment and two devices

The Food & Drug Administration issued warnings to Millipore Corp. and Cardiac Sciences Corp. and a Class I recall to Synthes USA. The FDA has concerns about one company’s diagnostic equipment, and malfunctioning defibrillators and vertebral implants from the other two companies.

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FDA seeks 23 percent budget increase for agency overhaul

The Food & Drug Administration asks Congress for a $4.03 billion budget for fiscal 2011, a 23 percent increase over the prior year, as it looks to increase its scrutiny of the medical device, pharmaceutical, food and tobacco industries even as it focuses on self-improvement.

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Medical device industry spends $20 million in federal lobbying at end of 2009

Medical device makers, health information technology providers and AdvaMed together spent more than $20 million lobbying Congress, the White House and the Food & Drug Administration during the fourth quarter.

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League of Women Voters urges quick response to nation’s health care crisis

League of Women Voters: Congress should not miss this historic opportunity to enact comprehensive health care reform legislation.

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FDA, ECRI Institute post lists of alternatives to STERIS Corp.’s System 1 sterilizer

The U.S. Food and Drug Administration has posted a notice on alternatives to System 1, the medical instrument sterilizer made by STERIS Corp. in Mentor, Ohio, that the administration considers a “violating device.”

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Business foes of health care reform outspend supporters 2-to-1 — MedCity Morning Read, Nov. 17, 2009

Business foes of health care reform legislation are outspending supporters at a rate of 2-to-1 for television advertisements as they get nervous about a final bill.

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