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 …
FDA today designated a ResMed (NYSE:RMD) recall of certain Stellar non-invasive and invasive ventilators as Class I — the agency’s most serious level. The sound alarm on the ventilators may not work if the device has a failed electronic part, is stored without AC power for more than 36 hours, or powers on automatically when connected …
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 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.
