FDA clears spinal cord stimulator from St. Jude

According to an article from FDAnews.com, “St. Jude Medical has won FDA 510(k) clearance for its Invisible Trial system, a spinal cord stimulator that incorporates Apple products and Bluetooth wireless technology.”  For more information on this clearance,...

Do FDA Regulations of Medical Devices Need to be Reevaluated?

According to an article from the Wall Street Journal, “The Food and Drug Administration works at striking the proper balance between insisting on safety but not standing in the way of innovative products that promote health and well-being. In doing so, it’s...

JUST ANNOUNCED: FDA to Start Regulating Medical Laboratory Testing

  The Food and Drug Administration has announced plans to begin regulating Laboratory Developed Tests (LDTs) to ensure that tests used to diagnose thousands of diseases and other conditions are reliable and accurate. In light of this important announcement, Q1...