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

The FDA launched an artificial intelligence tool Monday dubbed Elsa, with Commissioner Marty Makary hyping the effort’s early ...

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 US Food and Drug Administration (FDA) has granted breakthrough device designation to BiVACOR’s titanium Total Artificial ...

Mastering FDA Cybersecurity Blue Goat Cyber joins DeviceTalks Minnesota to showcase expert strategies for FDA-rea ...

CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR - On May 29, 2025, the U.S. Food ...

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 ...