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Alvaro Arjona Sánchez, Carlos Diaz Iglesias, Cesar Díaz López, David Martínez Cecilia, Jaime Alonso Gómez, Jose Gómez Barbadillo, and Sebastian Rufian Peña

✓ A rectothecal fistula secondary to anterior sacral meningocele is an extremely rare disease. To the authors' knowledge, only 2 cases have been reported in the English-language literature. It can cause symptoms by compressing adjacent structures, causing urinary difficulties and constipation. The authors report an unusual case of a patient in whom this condition was diagnosed as an incidental finding. The patient had a sacral myelomeningocele with secondary meningitis to a rectothecal fistula. The authors will briefly review the diagnosis, the various treatments, and the surgical approach to treat this infrequent entity.

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Robert Herrmann, Maureen Dreher, Andrew Farb, Michael Hoffmann, Christopher M. Loftus, Nina Mezu-Nwaba, Vivek Pinto, Xiaolin Zheng, and Carlos Peña

This article describes the efforts of the US Food and Drug Administration (FDA) Office of Neurological and Physical Medicine Devices to facilitate early clinical testing of potentially beneficial neurological devices in the US. Over the past 5 years, the FDA has made significant advances to this aim by developing early feasibility study best practices and encouraging developers and innovators to initiate their clinical studies in the US. The FDA uses several regulatory approaches to help start neurological device clinical studies, such as early engagement with sponsors and developers, in-depth interaction during the FDA review phase of a regulatory submission, and provision of an FDA toolkit that reviewers can apply to the most challenging submissions.