Building consensus on clinical outcome assessments for BCI devices. A summary of the 10th BCI society meeting 2023 workshop.

: The 10th International brain computer interface (BCI) Society Meeting, 'Balancing Innovation and Translation', was held from the 6th to 9th of June 2023 in Brussels, Belgium. This report provides a summary of the workshop ''. This workshop was intended to give participants an overview of the current state of BCI, future opportunities, and how different countries and regions provide regulatory oversight to support the BCI community to develop safe and effective devices for patients.

Navigating the FDA regulatory landscape.

Recent research and technological developments have led to an expanding number of novel and rapidly acting therapeutics being developed across a variety of neuropsychiatric disorders. Novel medical devices range from implantable and non-invasive brain stimulating and recording technologies to digital therapeutics. This perspective provides an overview of FDA regulatory oversight for medical devices, including a discussion of regulatory pathways and the review of neuromodulation devices for psychiatric disorders.

Use of accounting concepts to study research: return on investment in XSEDE, a US cyberinfrastructure service.

This paper uses accounting concepts-particularly the concept of Return on Investment (ROI)-to reveal the quantitative value of scientific research pertaining to a major US cyberinfrastructure project (XSEDE-the eXtreme Science and Engineering Discovery Environment). XSEDE provides operational and support services for advanced information technology systems, cloud systems, and supercomputers supporting non-classified US research, with an average budget for XSEDE of US$20M+ per year over the period studied (2014-2021). To assess the financial effectiveness of these services, we calculated a proxy for ROI, and converted quantitative measures of XSEDE service delivery into financial values using costs for service from the US marketplace.