Novo Nordisk’s once-daily GLP-1 tablet reduced major adverse cardiovascular events in high-risk adults, including those without prior heart attack or stroke.
A Lancet Commission definition integrating BMI with anthropometric measures increased obesity prevalence by ~60% in a major US cohort, identifying previously unrecognized high-risk patients while introducing distinct clinical phenotypes.
“These findings indicate that standardized efficacy, safety, and risk assessment reporting remains inadequate for FDA-cleared AI/ML devices, underscoring the need for dedicated regulatory pathways and robust postmarket surveillance to ensure patient safety."