On January 7, 2025, the Food and Drug Administration (FDA or Agency) announced the availability of a final guidance for ...

On January 7, 2025, the Food and Drug Administration (FDA or Agency) announced the availability of a final guidance for ...

On December 4, 2024, the Food and Drug Administration (FDA) announced a final guidance entitled “Marketing Submission Recommendations for a ...

On September 27, 2024, Hurricane Helene made landfall as a Category 4 storm and swept through the United States from ...

Generative AI is a type of artificial intelligence that can create new content based on existing content or data. The algorithm ...

Let’s explore the differences between Computer Systems Validation (CSV) and Computer Software Assurance (CSA): Tony is a truck driver, and ...

Last month, Apple kicked off its developer’s conference by announcing a few new software features critical to maintaining health and ...

The wait and suspense for the United States Food and Drug Administration’s (FDA) plans to harmonize and modernize the way ...

The rise of mental health apps promises an accessible option for diagnosis and treatment as more individuals want to be ...

Even though the medical device tax was passed in 2012 as a part of the Patient Protection and Affordable Care ...

The FDA has welcomed the use of AI in medical devices, as evidenced by the former commissioner’s optimistic attitude about ...

On November 26, 2018, FDA Commissioner Scott Gottlieb and Jeff Shuren, Director of the Center for Devices and Radiological Health, ...