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A five-year study of patients with acute coronary syndrome (ACS) revealed no notable difference in long-term clinical outcomes between those treated with titanium-nitride-oxide (TiNO)-coated stents or everolimus drug eluting stents (EES), both of which are used to widen narrow or blocked coronary arteries. Read More
Clinical trial sites venturing into the growing field of digital therapeutics (DTx) need the appropriate infrastructure — as well as tech know-how and adaptability — while sponsors need to be willing to offer training and support, iron out hurdles that come with remote components and simplify these trials whenever possible, a clinical research expert advises. Read More
The Veteran’s Health Administration (VHA), working with the FDA and several other agencies, has launched a challenge for the scientific and data analytics communities to develop AI and machine learning (ML) models to predict cardiovascular health outcomes, including readmission and mortality. Read More
Part 2 of our two-part series on the impact of artificial intelligence (AI) on medical devices focuses on the significant regulatory challenges.Read More
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.