Researchers in the United States have found that getting regular dental X-rays may significantly increase the risk of developing non-malignant brain tumors. Read the full article: Regular Dental X-rays and Brain Tumors Linked
FDA Wants Less Radiation Exposure
The FDA announced a proposal encouraging manufacturers to consider the safety of children in the design of new X-ray imaging devices. They are recommending that manufacturers design new X-ray imaging devices with protocols and instructions that address use on pediatric patients. It also proposes that manufacturers who do not follow their recommendation should include a label on their device that [...]
NuBone Osteoinductive Bone Graft Product Not Approved
Globus Medical is a spinal implant manufacturer privately held in Audubon, Pennsylvania. The FDA considers Globus Medical’s NuBone Osteoinductive a medical device that poses a lower level of risk to patients and therefore Globus Medical was only required to show that the NuBone Osteoinductive was substantially equivalent to similar medical devices that are already on the market. However, FDA investigators learned [...]
St. Jude’s Wants Study Retracted Due To Inaccuracy
St. Jude Medical has asked the Heart Rhythm Journal to retract a study published last month that linked its Riata line of internal defibrillator leads to more 20 deaths. In a statement issued by St. Jude, the company asserted the Riata lead study was biased and based on inaccurate facts. According to the Heart Rhythm [...]