FDA to Reclassify Device Software

FDA to Reclassify Device Software: "The Food and Drug Administration has published a proposed rule to reclassify the regulatory status of certain software used with medical devices. The rule would affect medical devices used in provider organizations and in patient homes."

Rules remain murky for medical devices - San Francisco Business Times:

Rules remain murky for medical devices - San Francisco Business Times:: Medical devices and diagnostics should be subject to examination by independent review organizations in addition to any FDA evaluations, according to a new analysis. "Device manufacturers have been able to get away with a much lower level of evidence in getting their devices to market," said a professor from the University of California, San Francisco.

Clinton replaces campaign manager - Los Angeles Times

Clinton replaces campaign manager - Los Angeles Times: "After losing all of the weekend's caucuses and primaries, Hillary Rodham Clinton announces that a longtime trusted aide will take the place of Patti Solis Doyle in running her campaign."

Medicare trend raises eyebrows over costs - Los Angeles Times

Medicare trend raises eyebrows over costs - Los Angeles Times: "Many large employers are struggling with the obligation to cover the rising medical costs of retirees, but last year officials in Michigan found a way to save at least $40 million on care for retired teachers and other public-school workers: Send the bills to Washington."

Proposed Budget Increase for FDA Aimed at Boosting Safety Measures - WSJ.com

Proposed Budget Increase for FDA Aimed at Boosting Safety Measures - WSJ.com: "The White House's 2009 budget request for the Food and Drug Administration would focus the bulk of the proposed $130 million budget increase on food-safety initiatives and on monitoring the safety of drugs and medical devices already on the market."

Keeping it clean, safe for patients - sacbee.com

Keeping it clean, safe for patients - sacbee.com: "A Sacramento-area hospital is emerging as a nationwide leader in the push to eliminate deadly infections picked up by unsuspecting hospital patients. Sutter Roseville Medical Center has overhauled the way it uses catheters inserted into patients' veins. The thin tubes are a common entryway for potentially toxic bacteria. The hospital has not had a single bloodstream infection among more than 3,000 of these patients for the past two years, as a result of the changes, said Sophie Harnage, the nurse who manages the hospital's infusion unit and developed the new system."

FDA caution, 'research drought' cuts drug approvals - USATODAY.com

FDA caution, 'research drought' cuts drug approvals - USATODAY.com: "Federal approvals of new drugs last year sank to the lowest in five years, a drop some industry analysts attribute to more cautious regulators and less innovation by drugmakers."