The FDA and the Medical Device Innovation Consortium (MDIC) are collaborating to offer funding of up to $300,000 to medical devicemakers that use advanced technologies to enhance product quality or improve the manufacturing process. Read More

Scientists have long been perceived and portrayed in film as old people in white lab coats perched at a bench full of bubbling fluorescent liquids. The present-day reality is quite different. Scientists are increasingly data jockeys in hoodies sitting before monitors analyzing enormous amounts of data. Modern day labs are more likely composed of sterile rows of robots doing the manual handling of materials, and lab notebooks are now electronic in massive data centers holding vast quantities of information. Today, scientific input comes from data pulled from the cloud, with algorithms fueling scientific discovery the way bunsen burners once did. Read More

A medical school research team and a digital therapeutics firm in South Korea used deep learning (DL) models to detect and assess autism in videos of children as young as 24 months of age by measuring a set of behaviors called “joint attention.” Read More

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 The New England Journal of Medicine.

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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).

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