There are problems with generative AI, and there need to be guardrails and there needs to be human oversight," said Jason ...

The Food and Drug Administration (FDA) has urged the Department of Health (DOH) to approve the immediate suspension of an ...

However, the integration of AI into medical devices raises significant regulatory challenges. Ensuring that these ...

Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers ...

Over the weekend, the Department of Justice (DOJ) did not file an appeal of the U.S. District Court for the Eastern District of Texas’ decision ...

The Trump Administration has effectively ended the Biden Administration's attempt to regulate lab-developed tests,” TD Cowen ...

SCOTTSDALE, AZ, UNITED STATES, June 4, 2025 /EINPresswire.com/ -- Blue Goat Cyber, a leading cybersecurity consultancy for FDA-regulated medical devices, has been announced as a Gold Sponsor of ...

The agency has provided only limited details about its AI pilot as it advances an “aggressive timeline” for the tool's ...

An agile, transparent, and ethics-driven oversight system is needed for the U.S. Food and Drug Administration (FDA) to ...

West Virginia Attorney General JB McCuskey issued a consumer alert Friday morning warning parents of certain vaping devices ...

SCOTTSDALE, AZ, UNITED STATES, June 3, 2025 /EINPresswire.com/ -- Blue Goat Cyber, a leading authority in medical device cybersecurity and FDA compliance strategy, proudly announces its sponsorship of ...