Abbott (NYSE:ABT) and Edwards Lifesciences (NYSE:EW) may have mislabeled patient deaths as injuries or device malfunctions in hundreds of FDA adverse event reports involving their transcatheter aortic or mitral valve replacement devices, according to a new study. The study by JAMA Internal Medicine editor Dr. Rita Redberg, former FDA unique device identification (UDI) external program manager Madris Tomes and others examined a total …
Researchers have used a deep-learning algorithm to detect lung cancer accurately from computed tomography scans. The results of the study indicate that artificial intelligence can outperform human evaluation of these scans. If you want to read more about this news click here.
«The Food and Drug Administration (FDA, Agency) identified a list of class I devices and class II devices that are now exempt from premarket notification requirements, subject to certain limitations. FDA published the lists of final determinations in accordance with procedures established by the 21stCentury Cures Act (Cures Act). Although each classification regulation for each …
The New York Times last Friday released an editorial calling for improved regulation on medical devices from the FDA, citing a number of recent controversial devices that have made headlines for injuries and deaths related to their use. If you want to read more about this news click here.