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Author

A. Marushima

3 papers indexed here

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Review Open access Sep 2026

Addressing Efficacy Uncertainties in Expedited Programs for Gene Therapy Products: A Comparative Assessment of Post-Approval Requirements by the FDA and EMA

Expedited programs accelerate the availability of gene therapy products but frequently leave uncertainties regarding efficacy at approval. How post-approval requirements are utilized to complement these specific evidence gaps remains unclear. To address this, we conducted a detailed analysis of 18 gene therapy products...

Kimika Nakamura, Yasuyuki Takashima, Shinya Watanabe et al. · 0 citations
Sep 2026

Human Recorded Signal Properties of Endovascular EEG Compared to Conventional Scalp EEG.

OBJECTIVE Endovascular EEG (eEEG) has emerged as a brain monitoring technique that offers a balance between signal fidelity and invasiveness. Endovascular electrodes match subdural recordings in bandwidth and signal-to-noise ratio in animal studies, however, their signal properties remain sparsely quantified in humans....

Luis Torres Mailleux, Kota Araki, Modar Hassan et al. · 0 citations
Sep 2026

Feasibility and Safety Evaluation of Hybrid Assistive Limb-Based Neurorehabilitation for Patients with Central Motor Dysfunction: A Single-Center Study.

OBJECTIVE Motor impairments caused by central nervous system (CNS) disorders lead to significant loss of functional independence in activities of daily living. The Hybrid Assistive Limb (HAL) is a wearable robotic device that augments voluntary movement and promotes CNS recovery via interactive biofeedback. We aimed to...

Yuichiro Soma, S. Kubota, Y. Shimizu et al. · 0 citations

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