“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."
Mobile magnetic resonance imaging units and rural hospital networks support independent hospitals in improving access to diagnostic imaging and patient care in underserved areas.
In a long-term cohort study, researchers found that specific retinal changes—thinner photoreceptor layers and thicker retinal pigment epithelium—were linked to a higher risk of developing amyotrophic lateral sclerosis, suggesting potential noninvasive biomarkers for early detection.