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.
Cohort of 198 coronary artery bypass grafting patients monitored for 1 year with insertable cardiac devices found high incidence of new-onset atrial fibrillation but minimal late burden.
“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."