Katie Palmer covers telehealth, clinical artificial intelligence, and the health data ... in the drug industry, the Food and Drug Administration Monday published its first draft guidance on ...

A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin tones.

The new entry to FDA’s database of Recognized ... Understanding and use of product bioburden data. Three of AAMI’s most notable sterilization guidance documents were also superseded by newer ...