Ontology highlight
ABSTRACT:
SUBMITTER: Ryan ME
PROVIDER: S-EPMC10805911 | biostudies-literature | 2024 Feb
REPOSITORIES: biostudies-literature
Ryan Morgan E ME Srivastava Siddharth S Wan Lin L Yang Guang G Zhang Bo B
Contemporary clinical trials communications 20240102
Neurological medical devices have revolutionized the management of neurological disorders, providing diagnostic, therapeutic, and monitoring solutions. High-risk neurological devices, such as deep brain stimulation and neurostimulators, offer groundbreaking treatments, emphasizing patient benefits while considering risks. To gain FDA approval, high-risk Class III devices necessitate premarket approval (PMA) applications with pivotal clinical trials, often assessing patient-reported outcomes (PRO ...[more]