Report Urges FDA to Scrap 510(K) Medical Device Approvals
A medical watchdog has called for the elimination of the system the U.S. Food & Drug Administration (FDA) uses to approve most medical devices. According to a panel from the Institute of Medicine, that streamlined process, known as 510(k) approval, offers patients no assurance of safety. As we ve reported in the past, 510(k) approvals are [...]

ShoulderFlex Massager Has Life Threatening Risks, Says FDA
After receiving a report of one death and one near strangulation, the Food and Drug Administration (FDA) is advising people to stop using the ShoulderFlex Massager, a home-use massager which massages the back, shoulder and neck while the patient is lying down on a flat surface. The ShoulderFlex Massager, which is distributed by King International, consists of a portable massager that is placed ...