The FDA issued Zoll Medical a warning letter outlining quality system regulation violations and violations of medical device ...

FDA revised guidance documents for low-risk wellness products and clinical decision software, clarifying regulatory ...

SubtleHD(CT) joins Subtle’s other AI medical imaging products including SubtlePET and SubtleHD(MR) that aim to improve PET ...

FDA issued a warning letter to Zoll Medical following a 14-month inspection of its Chelmsford, Massachusetts facility.

Since the late 1980s, FDA has been publicly declaring that there exists a category of software that technically qualifies as a medical device but for which FDA has no intention of requiring the ...

The Food and Drug Administration (FDA) has released guidance providing recommendations on what information should be included in a predetermined change control plan (PCCP) tailored to marketing ...