Computers, whether through simple decision trees or complex neural networks, are increasingly playing a larger and larger role in helping healthcare providers make treatment decisions. As the role of ...

“Don’t fear the Reaper,” the rock band Blue Öyster Cult famously advised. For many digital health companies, the Food and Drug Administration’s recently revised guidances affecting the classification ...

The US Food and Drug Administration’s (FDA) final guidance on clinical decision support (CDS) software goes against the statutory language laid out in the 21 st Century Cures Act, according to a legal ...