Why ‘approved’ medical devices in the U.S. may not be safe or effective

“Medtronic receives FDA clearance for two heart devices” “FDA approves device to help curb cluster headaches” MRI approved for young infants in intensive care Headlines like these instill consumer confidence that medical devices are safe and effective. After all, they have the FDA’s stamp of approval, right? The reality is, the FDA seldom requires rigorous … Continue reading Why ‘approved’ medical devices in the U.S. may not be safe or effective