{"id":"https://openalex.org/W7224135207","doi":"https://doi.org/10.5281/zenodo.23732538","title":"Regulatory Strategy for a Dual-Chamber Leadless Pacemaker System: Modularity Design Tradeoffs and the Competitive Landscape for Implantable Pacing Technology","display_name":"Regulatory Strategy for a Dual-Chamber Leadless Pacemaker System: Modularity Design Tradeoffs and the Competitive Landscape for Implantable Pacing Technology","publication_year":2026,"publication_date":"2026-10-28","ids":{"openalex":"https://openalex.org/W7224135207","doi":"https://doi.org/10.5281/zenodo.23732538"},"language":"en","primary_location":{"id":"doi:10.5281/zenodo.23732538","doi":"https://doi.org/10.5281/zenodo.23732538","is_oa":true,"landing_page_url":"https://doi.org/10.5281/zenodo.23732538","pdf_url":null,"source":{"id":"https://openalex.org/S4306400562","display_name":"Zenodo (CERN European Organization for Nuclear Research)","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I67311998","host_organization_name":"European Organization for Nuclear Research","host_organization_lineage":["https://openalex.org/I67311998"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"article-journal"},"volume":null,"type":"article","indexed_in":["datacite"],"open_access":{"is_oa":true,"oa_status":"green","oa_url":"https://doi.org/10.5281/zenodo.23732538","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5095789730","display_name":"Harshini Tanniru","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Tanniru, Harshini","raw_affiliation_strings":["Northeastern University, Toronto"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Northeastern University, Toronto","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5159990724","display_name":"Nazhat Abdul Farooq Malek","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Malek, Nazhat Abdul Farooq","raw_affiliation_strings":["Northeastern University, Toronto"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Northeastern University, Toronto","institution_ids":[]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5122807399","display_name":"Peivand Pirouzi","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Pirouzi, Peivand","raw_affiliation_strings":["Northeastern University and Crown College of Canada, Toronto, Canada"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Northeastern University and Crown College of Canada, Toronto, Canada","institution_ids":[]}]}],"institutions":[],"countries_distinct_count":0,"institutions_distinct_count":0,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":{"value":0.88308763,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":null,"issue":null,"first_page":null,"last_page":null},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10598","display_name":"Cardiac pacing and defibrillation studies","score":0.7929999828338623,"subfield":{"id":"https://openalex.org/subfields/2705","display_name":"Cardiology and Cardiovascular Medicine"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10598","display_name":"Cardiac pacing and defibrillation studies","score":0.7929999828338623,"subfield":{"id":"https://openalex.org/subfields/2705","display_name":"Cardiology and Cardiovascular Medicine"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T14396","display_name":"Healthcare Regulation","score":0.20419999957084656,"subfield":{"id":"https://openalex.org/subfields/3605","display_name":"Health Information Management"},"field":{"id":"https://openalex.org/fields/36","display_name":"Health Professions"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10512","display_name":"Orthopaedic implants and arthroplasty","score":0.0005000000237487257,"subfield":{"id":"https://openalex.org/subfields/2746","display_name":"Surgery"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/medical-device-regulation","display_name":"medical device regulation","score":0.8569999933242798},{"id":"https://openalex.org/keywords/fda-approval","display_name":"FDA approval","score":0.6669999957084656},{"id":"https://openalex.org/keywords/clinical-evidence-requirements","display_name":"clinical evidence requirements","score":0.8059999942779541},{"id":"https://openalex.org/keywords/post-marketing-surveillance","display_name":"post-marketing surveillance","score":0.6629999876022339},{"id":"https://openalex.org/keywords/competitive-landscape","display_name":"competitive landscape","score":0.6629999876022339},{"id":"https://openalex.org/keywords/quality-management-systems","display_name":"quality management systems","score":0.7549999952316284}],"concepts":[{"id":"https://openalex.org/C2779478453","wikidata":"https://www.wikidata.org/wiki/Q6889748","display_name":"Modularity (biology)","level":2,"score":0.6514999866485596},{"id":"https://openalex.org/C2779530757","wikidata":"https://www.wikidata.org/wiki/Q1207505","display_name":"Quality (philosophy)","level":2,"score":0.5005999803543091},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.46239998936653137},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.4262999892234802},{"id":"https://openalex.org/C3020535179","wikidata":"https://www.wikidata.org/wiki/Q6554101","display_name":"Medical device","level":2,"score":0.366100013256073},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.35929998755455017},{"id":"https://openalex.org/C123657996","wikidata":"https://www.wikidata.org/wiki/Q12271","display_name":"Architecture","level":2,"score":0.3352000117301941},{"id":"https://openalex.org/C2778642235","wikidata":"https://www.wikidata.org/wiki/Q3635544","display_name":"Cardiac pacemaker","level":2,"score":0.3111000061035156},{"id":"https://openalex.org/C201995342","wikidata":"https://www.wikidata.org/wiki/Q682496","display_name":"Systems engineering","level":1,"score":0.3050999939441681},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.3037000000476837},{"id":"https://openalex.org/C2777093003","wikidata":"https://www.wikidata.org/wiki/Q6508345","display_name":"Lead (geology)","level":2,"score":0.2946999967098236},{"id":"https://openalex.org/C3019398576","wikidata":"https://www.wikidata.org/wiki/Q1639780","display_name":"Regulatory agency","level":2,"score":0.2815000116825104},{"id":"https://openalex.org/C200601418","wikidata":"https://www.wikidata.org/wiki/Q2193887","display_name":"Reliability engineering","level":1,"score":0.25540000200271606}],"mesh":[],"locations_count":2,"locations":[{"id":"doi:10.5281/zenodo.23732538","doi":"https://doi.org/10.5281/zenodo.23732538","is_oa":true,"landing_page_url":"https://doi.org/10.5281/zenodo.23732538","pdf_url":null,"source":{"id":"https://openalex.org/S4306400562","display_name":"Zenodo (CERN European Organization for Nuclear Research)","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I67311998","host_organization_name":"European Organization for Nuclear Research","host_organization_lineage":["https://openalex.org/I67311998"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"article-journal"},{"id":"doi:10.5281/zenodo.23732539","doi":"https://doi.org/10.5281/zenodo.23732539","is_oa":true,"landing_page_url":"https://doi.org/10.5281/zenodo.23732539","pdf_url":null,"source":{"id":"https://openalex.org/S4306400562","display_name":"Zenodo (CERN European Organization for Nuclear Research)","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I67311998","host_organization_name":"European Organization for Nuclear Research","host_organization_lineage":["https://openalex.org/I67311998"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"article-journal"}],"best_oa_location":{"id":"doi:10.5281/zenodo.23732538","doi":"https://doi.org/10.5281/zenodo.23732538","is_oa":true,"landing_page_url":"https://doi.org/10.5281/zenodo.23732538","pdf_url":null,"source":{"id":"https://openalex.org/S4306400562","display_name":"Zenodo (CERN European Organization for Nuclear Research)","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I67311998","host_organization_name":"European Organization for Nuclear Research","host_organization_lineage":["https://openalex.org/I67311998"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"article-journal"},"sustainable_development_goals":[{"display_name":"Good health and well-being","score":0.8048999905586243,"id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W7224111120","https://openalex.org/W7224119736","https://openalex.org/W7224094992","https://openalex.org/W7140321037","https://openalex.org/W7224092101","https://openalex.org/W4396950553","https://openalex.org/W7221348977","https://openalex.org/W4415695012","https://openalex.org/W7221644441","https://openalex.org/W7117472651"],"abstract_inverted_index":{"The":[0],"development":[1],"of":[2,70],"high-risk":[3],"medical":[4,122],"devices":[5],"necessitates":[6],"thorough":[7],"regulatory":[8,88,134],"preparation,":[9],"extensive":[10],"clinical":[11,78,128],"evidence,":[12],"effective":[13],"project":[14,130],"management,":[15],"and":[16,86,95],"a":[17,27,32,48,52,71],"comprehensive":[18],"quality":[19],"management":[20],"system.":[21],"This":[22,64],"is":[23],"particularly":[24],"true":[25],"for":[26],"dual-chamber":[28,119],"leadless":[29,117,120],"pacemaker":[30],"system,":[31],"device":[33,73,110,123],"that":[34,56],"eliminates":[35],"the":[36,67,84,90,96,106],"transvenous":[37],"leads":[38],"associated":[39],"with":[40,102],"most":[41],"complications":[42],"in":[43,74],"conventional":[44],"pacing":[45,59],"while":[46],"introducing":[47],"distinct":[49],"design":[50],"tradeoff:":[51],"modular,":[53],"two-device":[54],"architecture":[55],"must":[57],"coordinate":[58],"between":[60],"separately":[61],"implanted":[62],"components.":[63],"article":[65],"discusses":[66],"technical":[68],"specifications":[69],"representative":[72],"this":[75,109],"category,":[76],"its":[77],"evidence":[79],"requirements,":[80],"classification":[81],"under":[82],"both":[83],"US":[85,93],"Canadian":[87,99],"frameworks,":[89],"route":[91],"to":[92,98,105,114],"approval,":[94],"pathway":[97],"market":[100],"access,":[101],"particular":[103],"attention":[104],"competitive":[107],"landscape":[108],"category":[111],"occupies":[112],"relative":[113],"established":[115],"single-chamber":[116],"alternatives.Keywords:":[118],"pacemaker;":[121],"regulation;":[124],"FDA;":[125],"Health":[126],"Canada;":[127],"evidence;":[129],"management;":[131],"post-market":[132],"surveillance;":[133],"artificial":[135],"intelligence":[136]},"counts_by_year":[],"updated_date":"2026-10-30T12:39:25.321706","created_date":"2026-10-29T00:00:00"}
