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In this two-part series, FDAnews examines the dramatic impact of artificial intelligence (AI) on medical devices and the significant challenges it presents for regulators. Part 1 is an overview of the use of AI in medical devices.Read More
An investigational artificial pancreas improved blood sugar levels in children age two to five with type 1 diabetes, researchers reported in TheNew England Journal of Medicine.
A postmarket study of a biometric chest patch and remote monitoring platform from Israel’s Biobeat Technologies showed a greater ability to identify patients with a high risk of health deterioration as compared to the standard National Early Warning Score (NEWS).
Two recent studies found that the DermaSensor skin cancer detection device showed a 94 percent sensitivity for correctly classifying high-risk skin cancer lesions, exceeding the accuracy of primary care physicians (PCPs).
Pain and bleeding were reduced in a clinical trial testing Aspivix’s Carevix cervical stabilizer device against a standard tenaculum — used to stabilize the cervix to ease passage of instruments — among women undergoing intrauterine device (IUD) placement to prevent pregnancy.
Abbott’s MitraClip cut the rate of hospitalizations while improving survival for heart failure patients with severe secondary mitral valve regurgitation (MR) in a five-year study at multiple U.S. medical centers.