Bloomberg -- High-risk medical devices are approved for sale without sufficient proof of safety by U.S. regulators who don’t monitor recalls when concerns arise during marketing, the Government Accountability Office found. The Food and Drug Administration has given expedited reviews to at least 67 devices such as pacemakers and hip joints since the GAO called in January 2009 for “immediate steps” to increase standards or reclassify the potential risks, according to testimony from Marcia Crosse, the GAO’s director of health care.
