Insight

NICE recognizes that the use of artificial intelligence (AI) methods, from relatively well-established machine learning approaches to newer and more complex generative AI, offers benefits such as processing and analyzing large datasets to reveal patterns and...

In May 2024, the decades-long debate between the FDA and CLIA program over regulation of LDTs, seemingly came to an end with the publication of an FDA final rule, making it explicit that IVDs are classified as devices under the FD&C Act, including when the...