Study highlights limits of premarket evaluation for identifying recalls of high-risk medical devices
More than one-third of high-risk therapeutic medical devices approved over the last decade were subject to serious recalls, but the lack of consistent characteristics of these recalled devices suggests the need for greater postmarket surveillance, according to the results of a recent cross-sectional study published in JAMA.
17 Aug 2026 Experts propose safety framework for improving predictability, interpretation of CNS toxicity The use and implementation of new approach methodologies (NAMs) and digital technologies such as artificial intelligence (AI) may help improve the predictability and interpretation of central nervous system (CNS) toxicity through non-clinical safety assessments, according to a recent paper proposing a new safety framework for predicting neurological risk in CNS drug development. Regulatory News
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