A federal grand jury indicted Thomas Sandgaard, 67, a Castle Rock resident, and Anna Lucsok, 39, a Denver resident, with ...
In 2025, the U.S. Food and Drug Administration (FDA or the Agency) issued a surprising number of enforcement letters to ...
CHARLOTTE, N.C. — A federal appeals court has upheld the conviction of a North Carolina ear, nose and throat doctor who reused single-use surgical devices on over 1,400 Medicare patients and defrauded ...
In November, the Food and Drug Administration (FDA) held a Digital Health Advisory Committee meeting where it considered treating artificial intelligence mental health chatbots as medical devices. As ...
The landscape of FDA medical device regulation has undergone a significant transformation. Today's regulatory environment presents both familiar challenges and entirely new complexities that device ...
A federal grand jury has charged two former executives of a Colorado medical device company with planning to cheat health ...
This week in Pedersen's POV, our senior editor argues against FDA's huge shift in digital health — made without public ...
CHARLOTTE, N.C. — A federal appeals court has upheld the conviction of a North Carolina ear, nose and throat doctor who reused single-use surgical devices on over 1,400 Medicare patients and defrauded ...
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