Today’s method of delivering software is failing many of the organizations that are trying to make software a core part of their business. If the technology sector doesn’t raise its game, software ...

On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance ...

In the fast-moving DevOps age, companies must better connect their silos so processes and tasks can flow more seamlessly and IT departments can work more quickly and efficiently. Workflows are ...

The Federal Circuit’s recent decision in Aristocrat Technologies will require software patent drafters to take more care to describe the algorithms covered by their software–or risk patent invalidity.

The Advanced Medical Technology Association (AdvaMed) urged the US Food and Drug Administration (FDA) to refine its draft guidance on device software in premarket submissions, asserting that requiring ...