Korrapati's implementation work is complemented by industry engagement, including presenting on CSA implementation and roadblocks at professional venues ...

On January 6, 2026, the US Food and Drug Administration (FDA) revised its final guidance on Clinical Decision Support ...

On January 6, 2026, the U.S. Food and Drug Administration (“FDA”) published revised final guidance documents on Clinical Decision Support ...

Industry consultant Michael Drues will discuss how medical device companies can better prepare for FDA inspections.

Siemens and NVIDIA expand their partnership to build the Industrial AI Operating System, reinventing the entire end-to-end ...

The main market opportunities include training on modern technologies for computer system validation, compliance with evolving FDA regulations, and risk-based approaches to validation using CSA and ...

The post The FDA's Hands-Off Approach to Medical AI Is a Win for Health-Conscious Consumers appeared first on Reason.com.

The FDA issued draft guidance Jan. 21 proposing the use of minimal residual disease and complete response as primary endpoints to support accelerated approval of drugs for multiple myeloma. The draft ...

On Jan. 6, 2026, the U.S. Food and Drug Administration (FDA) updated the final guidance documents General Wellness: Policy for Low Risk Devices (the General Wellness Guidance) and Clinical Decision ...

In the draft guidance, the agency discusses how sponsors can leverage MRD and complete response rates as near-term efficacy measures and speed new therapies to market.

Introduction Maternal and child mortality has markedly decreased worldwide over the past few decades. Despite this success, the decline remains unequal across countries and is overall insufficient to ...