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"parsedDate": "2012", "numChildren": 1 }, "data": { "key": "63BRF85K", "version": 19, "itemType": "journalArticle", "title": "A low-impedance, skin-grabbing, and gel-free EEG electrode", "creators": [ { "creatorType": "author", "firstName": "Mingui", "lastName": "Sun" }, { "creatorType": "author", "firstName": "Wenyan", "lastName": "Jia" }, { "creatorType": "author", "firstName": "Wei", "lastName": "Liang" }, { "creatorType": "author", "firstName": "Robert J", "lastName": "Sclabassi" } ], "abstractNote": "Inspired by the extraordinary object grabbing ability of certain insects (e.g., a grasshopper), we have developed a novel dry EEG electrode, called the skin screw electrode. Unlike the traditional disc electrode which requires several minutes to install, the installation of the skin screw electrode can be completed within seconds since no skin preparation and electrolyte application are required. Despite the drastic improvement in the installation time, our experiments have demonstrated that the skin screw electrode has a similar impedance value to that of the disc electrode. The skin screw electrode has a wide range of applications, such as clinical EEG diagnosis, epilepsy monitoring, emergency medicine, and home-based human-computer interface.", "publicationTitle": "Conference proceedings: ... Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. 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(FDA) is charged with assuring the safety and effectiveness of medical devices. Before any medical device can be brought to market, it must comply with all federal regulations regarding FDA processes for clearance or approval. Navigating the FDA regulatory process may seem like a daunting task to the innovator of a novel medical device who has little experience with the FDA regulatory process or device commercialization. This review introduces the basics of the FDA regulatory premarket process, with a focus on issues relating to chronically implanted recording devices in the central or peripheral nervous system. Topics of device classification and regulatory pathways, the use of standards and guidance documents, and optimal time lines for interaction with the FDA are discussed. Additionally, this article summarizes the regulatory research on neural implant safety and reliability conducted by the FDA's Office of Science and Engineering Laboratories (OSEL) in collaboration with Defense Advanced Research Projects Agency (DARPA) Reliable Neural Technology (RE-NET) Program. For a more detailed explanation of the medical device regulatory process, please refer to several excellent reviews of the FDA's regulatory pathways for medical devices [1]-[4].", "publicationTitle": "IEEE pulse", "publisher": "", "place": "", "date": "Mar 2012", "volume": "3", "issue": "2", "section": "", "partNumber": "", "partTitle": "", "pages": "37-41", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "IEEE Pulse", "DOI": "10.1109/MPUL.2011.2181022", "citationKey": "", "url": "", "accessDate": "", "PMID": "", "PMCID": "", "ISSN": "2154-2287", "archive": "", "archiveLocation": "", "shortTitle": "FDA regulation of invasive neural recording electrodes", "language": "eng", "libraryCatalog": "NCBI PubMed", "callNumber": "", "rights": "", "extra": "PMID: 22481744", "tags": [ { "tag": "Clinical Trials as Topic", "type": 1 }, { "tag": "Device Approval", "type": 1 }, { "tag": "Diagnostic Techniques, Neurological", "type": 1 }, { "tag": "Electrodes, Implanted", "type": 1 }, { "tag": "Equipment Safety", "type": 1 }, { "tag": "Humans", "type": 1 }, { "tag": "United States", "type": 1 }, { "tag": "United States Food and Drug Administration", "type": 1 } ], "collections": [ "ED2FADJS" ], "relations": {}, "dateAdded": "2014-04-16T15:25:49Z", "dateModified": "2014-04-16T15:25:49Z" } }, { "key": "PVGIA6KB", "version": 14, "library": { "type": "group", "id": 251160, "name": "Advanced Design Epilepsy Research", "links": { "alternate": { "href": "https://www.zotero.org/groups/advanced_design_epilepsy_research", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/251160/items/PVGIA6KB", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/advanced_design_epilepsy_research/items/PVGIA6KB", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/251160/items/KRCE8PCS", "type": "application/json" } }, "meta": { "createdByUser": { "id": 1303414, "username": "wbr5dc", "name": "", "links": { "alternate": { "href": "https://www.zotero.org/wbr5dc", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "PVGIA6KB", "version": 14, "parentItem": "KRCE8PCS", "itemType": "attachment", "linkMode": "imported_url", "title": "Google Patents PDF", "accessDate": "2014-04-09T23:33:13Z", "url": "http://patentimages.storage.googleapis.com/pdfs/US8588884.pdf", "note": "", "contentType": "application/pdf", "charset": "", "filename": "Hegde et al. - 2013 - Microneedle electrode.pdf", "md5": "2fd19797f7353ceb2053f830e99199af", "mtime": 1397086397542, "tags": [], "relations": {}, "dateAdded": "2014-04-09T23:33:13Z", "dateModified": "2014-04-09T23:33:17Z" } }, { "key": "KRCE8PCS", "version": 13, "library": { "type": "group", "id": 251160, "name": "Advanced Design Epilepsy Research", "links": { "alternate": { "href": "https://www.zotero.org/groups/advanced_design_epilepsy_research", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/251160/items/KRCE8PCS", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/advanced_design_epilepsy_research/items/KRCE8PCS", "type": "text/html" } }, "meta": { "createdByUser": { "id": 1303414, "username": "wbr5dc", "name": "", "links": { "alternate": { "href": "https://www.zotero.org/wbr5dc", "type": "text/html" } } }, "creatorSummary": "Hegde et al.", "parsedDate": "2013-11-19", "numChildren": 1 }, "data": { "key": "KRCE8PCS", "version": 13, "itemType": "patent", "title": "Microneedle electrode", "creators": [ { "creatorType": "inventor", "firstName": "Anant V.", "lastName": "Hegde" }, { "creatorType": "inventor", "firstName": "Amit", "lastName": "Rajguru" }, { "creatorType": "inventor", "firstName": "Daniel Rogers", "lastName": "Burnett" }, { "creatorType": "inventor", "firstName": "Christopher", "lastName": "Hermanson" } ], "abstractNote": "In certain variations, methods, systems and/or devices for enhancing conductivity of an electrical signal through a subject's skin using one or more microneedle electrodes are provided. A microneedle electrode may be applied to the subject's skin by placing the microneedle electrode in direct contact with the subject's skin. The microneedles of the microneedle electrode may be inserted into the skin such that the microneedles pierce stratum corneum of the skin up to or through dermis of the skin. An electrical signal passes or is conducted through or across the microneedle electrode and the subject's skin, where impedance of the microneedle electrode is minimal and greatly reduced compared to existing technologies.", "place": "", "country": "United States", "assignee": "Emkinetics, Inc.", "issuingAuthority": "", "patentNumber": "US8588884 B2", "filingDate": "May 28, 2010", "pages": "", "applicationNumber": "", "priorityNumbers": "", "issueDate": "Nov 19, 2013", "priorityDate": "", "references": "", "legalStatus": "", "DOI": "", "citationKey": "", "url": "", "accessDate": "", "shortTitle": "", "language": "", "rights": "", "extra": "U.S. Classification 600/372, 600/391, 600/373, 607/142, 607/149; International Classification A61B5/0478, A61N1/04, A61B5/0492, A61B5/0416, A61B5/0408; Cooperative Classification A61B5/0408, A61B5/0492, A61B5/0478", "tags": [], "collections": [ "ED2FADJS" ], "relations": {}, "dateAdded": "2014-04-09T23:33:13Z", "dateModified": "2014-04-09T23:33:13Z" } }, { "key": "26EDB2ND", "version": 12, "library": { "type": "group", "id": 251160, "name": "Advanced Design Epilepsy Research", "links": { "alternate": { "href": "https://www.zotero.org/groups/advanced_design_epilepsy_research", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/251160/items/26EDB2ND", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/advanced_design_epilepsy_research/items/26EDB2ND", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/251160/items/HZ4NABN3", "type": "application/json" } }, "meta": { "createdByUser": { "id": 1303414, "username": "wbr5dc", "name": "", "links": { "alternate": { "href": "https://www.zotero.org/wbr5dc", "type": "text/html" } } } }, "data": { "key": "26EDB2ND", "version": 12, "parentItem": "HZ4NABN3", "itemType": "attachment", "linkMode": "imported_url", "title": "Snapshot", "accessDate": "2014-04-09T23:18:07Z", "url": "http://link.springer.com/chapter/10.1007%2F978-3-540-89208-3_297", "note": "", "contentType": "text/html", "charset": "utf-8", "filename": "10.html", "md5": "f18b477f47e9058990b996af0f13870d", "mtime": 1397085487561, "tags": [], "relations": {}, "dateAdded": "2014-04-09T23:18:07Z", "dateModified": "2014-04-09T23:18:07Z" } }, { "key": "HZ4NABN3", "version": 11, "library": { "type": "group", "id": 251160, "name": "Advanced Design Epilepsy Research", "links": { "alternate": { "href": "https://www.zotero.org/groups/advanced_design_epilepsy_research", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/251160/items/HZ4NABN3", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/advanced_design_epilepsy_research/items/HZ4NABN3", "type": "text/html" } }, "meta": { "createdByUser": { "id": 1303414, "username": "wbr5dc", "name": "", "links": { "alternate": { "href": "https://www.zotero.org/wbr5dc", "type": "text/html" } } }, "creatorSummary": "Luttge et al.", "parsedDate": "2009-01-01", "numChildren": 1 }, "data": { "key": "HZ4NABN3", "version": 11, "itemType": "bookSection", "title": "Microneedle array electrode for human EEG recording", "creators": [ { "creatorType": "author", "firstName": "Regina", "lastName": "Luttge" }, { "creatorType": "author", "firstName": "S. N.", "lastName": "Bystrova" }, { "creatorType": "author", "firstName": "M. J. A. M. van", "lastName": "Putten" }, { "creatorType": "editor", "firstName": "Jos Vander", "lastName": "Sloten" }, { "creatorType": "editor", "firstName": "Pascal", "lastName": "Verdonck" }, { "creatorType": "editor", "firstName": "Marc", "lastName": "Nyssen" }, { "creatorType": "editor", "firstName": "Jens", "lastName": "Haueisen" } ], "abstractNote": "Microneedle array electrodes for EEG significantly reduce the mounting time, particularly by circumvention of the need for skin preparation by scrubbing. We designed a new replication process for numerous types of microneedle arrays. Here, polymer microneedle array electrodes with 64 microneedles, in a nested 4×4 array, positioned on a circular disk of 10 mm diameter were fabricated and characterized. Needles have a length of 320 μm with a diameter of 100 μm. The DC-resistance of Ag-coated microneedle array electrodes on the skin is of the order of 150 kΩ. Using electrolyte gel this value decreases at least by a factor of 10. The pilot measurements on a healthy volunteer show excellent signal-to-noise ratios. According to conventional electrodes also Ag/AgCl instead of Ag only was used to coat the microneedle array. Both coatings, either with or without gel, certified for EEG recordings.", "bookTitle": "4th European Conference of the International Federation for Medical and Biological Engineering", "series": "IFMBE Proceedings", "seriesNumber": "22", "volume": "", "numberOfVolumes": "", "edition": "", "date": "2009/01/01", "publisher": "Springer Berlin Heidelberg", "place": "", "originalDate": "", "originalPublisher": "", "originalPlace": "", "format": "", "pages": "1246-1249", "ISBN": "978-3-540-89207-6, 978-3-540-89208-3", "DOI": "", "citationKey": "", "url": "http://link.springer.com/chapter/10.1007/978-3-540-89208-3_297", "accessDate": "2014-04-09T23:18:04Z", "ISSN": "", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "en", "libraryCatalog": "link.springer.com", "callNumber": "", "rights": "©2009 Springer Berlin Heidelberg", "extra": "", "tags": [ { "tag": "Biomedical Engineering", "type": 1 }, { "tag": "EEG", "type": 1 }, { "tag": "Microneedle array", "type": 1 }, { "tag": "alpha-rhythm", "type": 1 }, { "tag": "microfabrication", "type": 1 }, { "tag": "molding", "type": 1 } ], "collections": [ "ED2FADJS" ], "relations": {}, "dateAdded": "2014-04-09T23:18:04Z", "dateModified": "2014-04-09T23:18:04Z" } }, { "key": "KDF35DZZ", "version": 10, "library": { "type": "group", "id": 251160, "name": "Advanced Design Epilepsy Research", "links": { "alternate": { "href": "https://www.zotero.org/groups/advanced_design_epilepsy_research", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/251160/items/KDF35DZZ", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/advanced_design_epilepsy_research/items/KDF35DZZ", "type": "text/html" } }, "meta": { "createdByUser": { "id": 1303414, "username": "wbr5dc", "name": "", "links": { "alternate": { "href": "https://www.zotero.org/wbr5dc", "type": "text/html" } } }, "creatorSummary": "Giacometti and Diamond", "parsedDate": "2013-02", "numChildren": 1 }, "data": { "key": "KDF35DZZ", "version": 10, "itemType": "journalArticle", "title": "Compliant head probe for positioning electroencephalography electrodes and near-infrared spectroscopy optodes", "creators": [ { "creatorType": "author", "firstName": "Paolo", "lastName": "Giacometti" }, { "creatorType": "author", "firstName": "Solomon G", "lastName": "Diamond" } ], "abstractNote": "A noninvasive head probe that combines near-infrared spectroscopy (NIRS) and electroencephalography (EEG) for simultaneous measurement of neural dynamics and hemodynamics in the brain is presented. It is composed of a compliant expandable mechanism that accommodates a wide range of head size variation and an elastomeric web that maintains uniform sensor contact pressure on the scalp as the mechanism expands and contracts. The design is intended to help maximize optical and electrical coupling and to maintain stability during head movement. Positioning electrodes at the inion, nasion, central, and preauricular fiducial locations mechanically shapes the probe to place 64 NIRS optodes and 65 EEG electrodes following the 10-5 scalp coordinates. The placement accuracy, precision, and scalp pressure uniformity of the sensors are evaluated. A root-mean-squared (RMS) positional precision of 0.89 ± 0.23 mm, percent arc subdivision RMS accuracy of 0.19 ± 0.15%, and mean normal force on the scalp of 2.28 ± 0.88 N at 5 mm displacement were found. Geometric measurements indicate that the probe will accommodate the full range of adult head sizes. The placement accuracy, precision, and uniformity of sensor contact pressure of the proposed head probe are important determinants of data quality in noninvasive brain monitoring with simultaneous NIRS-EEG.", "publicationTitle": "Journal of biomedical optics", "publisher": "", "place": "", "date": "Feb 2013", "volume": "18", "issue": "2", "section": "", "partNumber": "", "partTitle": "", "pages": "27005", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "J Biomed Opt", "DOI": "10.1117/1.JBO.18.2.027005", "citationKey": "", "url": "", "accessDate": "", "PMID": "", "PMCID": "", "ISSN": "1560-2281", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "eng", "libraryCatalog": "NCBI PubMed", "callNumber": "", "rights": "", "extra": "PMID: 23377012 \nPMCID: PMC3560444", "tags": [ { "tag": "Adult", "type": 1 }, { "tag": "Brain", "type": 1 }, { "tag": "Brain Mapping", "type": 1 }, { "tag": "Electrodes", "type": 1 }, { "tag": "Head", "type": 1 }, { "tag": "Hemodynamics", "type": 1 }, { "tag": "Humans", "type": 1 }, { "tag": "Imaging, Three-Dimensional", "type": 1 }, { "tag": "Magnetic Resonance Imaging", "type": 1 }, { "tag": "Models, Anatomic", "type": 1 }, { "tag": "Optical Devices", "type": 1 }, { "tag": "Optical Phenomena", "type": 1 }, { "tag": "Spectroscopy, Near-Infrared", "type": 1 }, { "tag": "electroencephalography", "type": 1 } ], "collections": [ "ED2FADJS" ], "relations": {}, "dateAdded": "2014-04-04T02:45:11Z", "dateModified": "2014-04-04T02:45:11Z" } }, { "key": "P5Z3KDSS", "version": 10, "library": { "type": "group", "id": 251160, "name": "Advanced Design Epilepsy Research", "links": { "alternate": { "href": "https://www.zotero.org/groups/advanced_design_epilepsy_research", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/251160/items/P5Z3KDSS", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/advanced_design_epilepsy_research/items/P5Z3KDSS", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/251160/items/KDF35DZZ", "type": "application/json" } }, "meta": { "createdByUser": { "id": 1303414, "username": "wbr5dc", "name": "", "links": { "alternate": { "href": "https://www.zotero.org/wbr5dc", "type": "text/html" } } } }, "data": { "key": "P5Z3KDSS", "version": 10, "parentItem": "KDF35DZZ", "itemType": "attachment", "linkMode": "linked_url", "title": "PubMed entry", "accessDate": "2014-04-04T02:45:11Z", "url": "http://www.ncbi.nlm.nih.gov/pubmed/23377012", "note": "", "contentType": "text/html", "charset": "", "tags": [], "relations": {}, "dateAdded": "2014-04-04T02:45:11Z", "dateModified": "2014-04-04T02:45:11Z" } } ]