Brain-computer interface devices for patients with paralysis and amputation: a meeting report.

OBJECTIVE: The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) believes it is important to help stakeholders (e.g., manufacturers, health-care professionals, patients, patient advocates, academia, and other government agencies) navigate the regulatory landscape for medical devices. For innovative devices involving brain-computer interfaces, this is particularly important. APPROACH: Towards this goal, on 21 November, 2014, CDRH held an open public workshop on its White Oak, MD campus with the aim of fostering an open discussion on the scientific and clinical considerations associated with the development of brain-computer interface (BCI) devices, defined for the purposes of this workshop as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities. MAIN RESULTS: This paper summarizes the presentations and discussions from that workshop. SIGNIFICANCE: CDRH plans to use this information to develop regulatory considerations that will promote innovation while maintaining appropriate patient protections. FDA plans to build on advances in regulatory science and input provided in this workshop to develop guidance that provides recommendations for premarket submissions for BCI devices. These proceedings will be a resource for the BCI community during the development of medical devices for consumers.

Effect of foot-progression angle on hip joint moments during gait.

Loosening has emerged as the most serious long-term complication of total hip replacement and torsional loading of the femoral implant has been implicated as a possible cause. In an effort to explore a strategy for minimizing this risk, the following hypothesis was tested: the foot-progression angle has a significant effect on the resultant hip moments, and particularly the internal-external rotation moment, during level walking. Twelve normal subjects performed a total of nine trials: three in which they walked normally with the right foot pointing approximately straight ahead; three in which they were told to walk with the foot internally rotated approximately 30 degrees; and three in which the foot was externally rotated about 30 degrees. The inverse dynamics approach was used to integrate the body segment parameter, kinematic and force plate data, and to solve for the resultant moment at the right hip joint. In all three conditions--foot straight, foot in, and foot out-the subjects walked at the same average speed of 1.5 (+/- 0.3) ms-1. For the flexion-extension moment (where the maximum flexion moment of 95 Nm was in good agreement with other published data), there was no significant difference between the three foot orientation conditions. For the abduction-adduction moment, the foot straight condition exhibited the classic double peak pattern with a maximum abductor moment of 57 Nm, and there was no statistically significant difference between the three curves.(ABSTRACT TRUNCATED AT 250 WORDS)