tbuckley/cabot-search huggingface dataset:
Effect of High-Intensity vs Low-Intensity Noninvasive Positive Pressure Ventilation on the Need for Endotracheal Intubation—Reply
Authors: Zujin Luo, Yichong Li, Zhixin Cao
Journal: JAMA (2025)

Zujin Luo, MD; Yichong Li, PhD; Wenjun Li, MD; Ying Li, MD; Qingrong Nie, MD; Yu Shi, PhD; Juan Wang, BSN; Qiuling Ji, MD; Xuefeng Han, MD; Sijie Liu, MD; Dongmei Li, MD; ShaSha Wang, MD; Zhijun Li, MD; Dong Jia, MD; Huiqing Ge, MD; Peifeng Xu, BSc; Zhijun Feng, MD; Fengjie Li, MD; Fucheng An, MD; Na Tai, MD; Lili Yue, MD; Hongwei Xie, MD; Xiuhong Jin, MD; Hongru Liu, MD; Qiang Dang, MD; Yongxiang Zhang, MD; Li Sun, MD; Jinxiang Wang, MD; He Huang, MD; Liang Chen, MD; Yingmin Ma, MD; Zhixin Cao, MD; Chen Wang, MD, PhD; HAPPEN Investigators; Wenyao Fang; Dawei Zheng; Jingwen Wang; Xiaoguo Zhou; Xia Liu; Yanan Liu; Lina Liu; Congbin Yang; Zhenyang Xu; Ruiyan Lin; Jingjing Yang; Yan Peng; Jian Li; Chunxiao Yu; Xuemei Ling; Shan Ming; xinju Xu; Xiaohua Hou; Yongfa Zhang; Xiaohua Xue; Haiying Ma; Yun Shen; Xiuzhi Yang; Yongpeng An; Ting Mo; Xianyin Sang; Lidan Sun; Huaying Shi; Hua Zhang; Peng Zhang; Xiaoxia Chen; Lizhou Han; Yang Zhang; Zeng Wang; Yuping Guo; Yi Xiang; Jun Feng; Hua Qiao; Fei Chen; Xiaohong Yang; Chao Wu; Abudusalamu Abula; Jin Tong; Yalan Qin
Fireflies
Authors: Julia L. McDonald
Journal: JAMA (2025)

Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy | Continue JAMA HomeNew OnlineCurrent IssueFor Authors JAMA+ AI Journals JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry (1919-1959) Podcasts Clinical Reviews Editors' Summary Medical News Author Interviews More JN Learning / CMESubscribeJobsInstitutions / LibrariansReprints & Permissions Terms of Use | Privacy Policy | Accessibility Statement 2025 American Medical Association. All Rights Reserved Search All JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Forum Archive JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry Input Search Term Sign In Individual Sign In Sign inCreate an Account Access through your institution Sign In Purchase Options: Buy this article Rent this article Subscribe to the JAMA journal
Area Socioeconomic Status, Vaccination Access, and Female Human Papillomavirus Vaccination
Authors: Emiko Oka, Megumi Okada, Yoshiko Ikuno, Kokoro Amano, Sakiko Shioya, Migiri Kawabata, Rie Sakurai, Miki Konishi, Tomoki Nakaya, Kota Katanoda, Yutaka Ueda, Yuri Ito
Journal: JAMA Network Open (2025)

Importance Although evaluation of geographic area inequities in vaccination is crucial to identify areas that need community-based interventions, knowledge of disparities in human papillomavirus (HPV) vaccination uptake remains limited in Japan. Objective To investigate the association of female cumulative HPV vaccination uptake with neighborhood-based socioeconomic status and access indicators in Osaka City, Japan. Design, Setting, and Participants This population-based, cross-sectional study included HPV vaccination data for fiscal year (April 1 to March 31) 2013 to fiscal year 2022 provided by Osaka City. The study population comprised the total number of girls eligible for HPV vaccination born between fiscal years 1997 and 2010. Exposure The area deprivation index (ADI) was used as a neighborhood-based socioeconomic status indicator, and the number of medical facilities providing HPV vaccination within a 500-m range of a representative point in each geographic area was used as an access indicator. Main Outcomes and Measures The primary outcome was cumulative uptake, defined as the cumulative number of girls receiving at least 1 dose and those completing all doses (3 doses until March 2023), by neighborhood ADI and access indicators. A Poisson regression model with robust variance was applied to assess the association of neighborhood-level indicators with cumulative HPV vaccination uptake. Results In Osaka City, 185 373 girls (median [IQR] age at vaccination, 16 [14-19] years) were eligible for HPV vaccination, of whom 18 688 (10.1%) received at least 1 dose of HPV vaccine. Compared with girls living in areas with the most deprivation (2539 of 28 078 [9.0%]), those living in areas with the least deprivation (4889 of 42 170 girls [11.6%]) had a greater cumulative HPV vaccination uptake (prevalence ratio [PR], 1.25; 95% CI, 1.16-1.34). In addition, compared with girls living in areas with low medical facility access (5128 of 55 055 [9.3%]), those residing in high-access areas (5862 of 54 740 [10.7%]) had a greater cumulative vaccination uptake (PR, 1.09; 95% CI, 1.03-1.16). Cumulative HPV vaccination was significantly associated with ADI in routine vaccination (least vs most deprivation: PR, 1.46; 95% CI, 1.33-1.61) but not in catch-up vaccination (least vs most deprivation: PR, 1.01; 95% CI, 0.92-1.11). Conclusions and Relevance In this cross-sectional study of area deprivation, vaccination access, and HPV vaccination status, higher socioeconomic status and higher medical facility access were associated with higher cumulative HPV vaccination uptake. These findings suggest that further strategies, including a socioecologic approach, are needed to increase HPV vaccination and reduce disparities in uptake.
Alcohol Use Disorder Medication Coverage and Utilization Management in Medicaid Managed Care Plans
Authors: Maureen T. Stewart, Sage R. Feltus, Christina M. Andrews, Andrea Acevedo, Cindy Parks Thomas, Jeffrey Bratberg, Constance M. Horgan, Dominic Hodgkin, Rachel Sayko Adams
Journal: JAMA Network Open (2025)

Importance Evidence-based, patient-centered treatment for alcohol use disorder (AUD) can include pharmacotherapy with naltrexone, acamprosate, or disulfiram; however, these medications are rarely used. Medicaid managed care plans (MCPs) manage health services for nearly 80% of Medicaid enrollees and are the largest payer for addiction treatment services. Little is known about Medicaid MCP policies for AUD medications. Objectives To describe Medicaid MCPs’ coverage and management of acamprosate, naltrexone, and disulfiram for AUD and examine associations of plan characteristics and state policies with medication coverage. Design, Setting, and Participants In this cross-sectional study, a content analysis was performed of 2021 insurance benefit data for 241 comprehensive Medicaid MCPs in states using Medicaid managed care, as well as secondary sources. Data were analyzed from May to August 2024. Main Outcomes and Measures Medicaid MCP-reported medication coverage and utilization management requirements (eg, prior authorization, quantity limit requirements) for acamprosate, disulfiram, and oral and injectable naltrexone together and for each medication separately. Independent variables included plan characteristics (profit status, market share) and the state policy environment in which plans are embedded (Section 1115 substance use disorder waiver, state-defined preferred drug list). Regressions examined associations of plan characteristics and state policies with medication coverage. Results In this cross-sectional content analysis of 241 comprehensive Medicaid MCPs in 2021, 217 (90.0%) covered at least 1 medication for AUD: 132 (54.7%) covered acamprosate, 203 (84.2%) covered oral naltrexone, 175 (72.6%) covered injectable naltrexone, 152 (63.0%) covered disulfiram, and 103 (42.7%) covered all 4 medications. Prior authorization and quantity limits were rarely applied, except for injectable naltrexone, for which 75 plans (42.8%) imposed at least 1 of these utilization management requirements. Conclusions and Relevance This study suggests that efforts to expand AUD medication prescribing may be limited by gaps in health insurance coverage. Medicaid MCPs and states can support AUD medication utilization by covering these medications without applying utilization management strategies.
Prenatal Depression and Symptom Severity by Maternal Race and Ethnicity
Authors: Kendria Kelly-Taylor, Sara Aghaee, Joshua Nugent, Nina Oberman, Ai Kubo, Elaine Kurtovich, Charles P. Quesenberry, Ayesha C. Sujan, Kathryn Erickson-Ridout, Mibhali M. Bhalala, Lyndsay A. Avalos
Journal: JAMA Network Open (2025)

This cross-sectional study compares the prevalence and risk for diagnosed and undiagnosed prenatal depression among pregnant individuals of different races and ethnicities.
Veliparib Plus Temozolomide for <i>MGMT</i>-Methylated Glioblastoma—Reply
Authors: Jann N. Sarkaria, Sani H. Kizilbash, Caterina Giannini
Journal: JAMA Oncology (2025)

Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy | Continue JAMA Oncology HomeNew OnlineCurrent IssueFor Authors Podcast JAMA+ AI Journals JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry (1919-1959) JN Learning / CMESubscribeJobsInstitutions / LibrariansReprints & Permissions Terms of Use | Privacy Policy | Accessibility Statement 2025 American Medical Association. All Rights Reserved Search All JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Forum Archive JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry Input Search Term Sign In Individual Sign In Sign inCreate an Account Purchase Options: Buy this article Rent this article Subscribe to the JAMA Oncology journal
The Childcare Crisis in Medical Training—A High-Stakes Problem With Elusive Solutions
Authors: Erika L. Rangel
Journal: JAMA Network Open (2025)

Margaret G. Mercante, BA; Emily G. Tocco, BS; Nidhi Kuchimanchi, BS; Mohamad El Moheb, MD; Maria F. Nunez; Mackenzie M. Mayhew, MD; Susan J. Kim, MD; Allan Tsung, MD; Lily S. Cheng, MD; Russell G. Witt, MD, MAS
Adjuvant Chemoradiotherapy vs Radiotherapy Alone for Patients With Intermediate-Risk Cervical Cancer
Authors: Núria Agustí, David Viveros-Carreño, Chi-Fang Wu, Roni Nitecki Wilke, Alexa Kanbergs, Karla Barajas, Abigail S. Zamorano, René Pareja, Alexander Melamed, J. Alejandro Rauh-Hain
Journal: JAMA Oncology (2025)

Importance Optimal adjuvant treatment for patients with intermediate-risk cervical cancer remains controversial, and the benefit of adding chemotherapy to radiotherapy in this population is uncertain. Objective To evaluate whether adjuvant chemoradiotherapy is associated with improved overall survival compared with radiotherapy alone in patients with intermediate-risk cervical cancer. Secondary objectives included identifying clinical factors associated with the use of chemoradiotherapy. Design, Setting, and Participants A cohort study was conducted at Commission on Cancer–accredited centers across the US using prospectively collected data from the National Cancer Database that focused on patients with a diagnosis of 2018 International Federation of Gynecology and Obstetrics stage IB cervical carcinoma (squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma) of intermediate risk who were undergoing adjuvant radiotherapy treatment after radical hysterectomy from January 2010 through December 2020. Missing variables were multiple imputed, and propensity score matching (1:1) was performed to balance baseline characteristics. A Kaplan-Meier analysis and proportional hazard models were used to compare the hazard of death between the groups. Exposure Adjuvant radiotherapy alone vs concurrent chemoradiotherapy. Main Outcome and Measure The primary outcome was time to death or last follow-up. Results A total of 1116 patients (mean [SD] age, 47 [12] years) were identified, of whom 486 (43.5%) received concurrent chemoradiotherapy. Chemotherapy was administered more frequently among those with adenocarcinoma or adenosquamous histology compared with squamous cell carcinoma (risk ratio [RR], 1.26; 95% CI, 1.10-1.44) and those with tumors larger than 4 cm (compared with tumors measuring 2-4 cm; RR, 1.31; 95% CI, 1.14-1.51). Propensity score matching yielded a cohort of 868 patients with balanced covariates. Patients who received chemoradiotherapy had similar overall survival (5- year survival, 87%) as those who received radiotherapy alone (5-year survival, 87%; hazard ratio, 0.85; 95% CI, 0.59-1.23; P = .38). There were no significant differences in survival associated with chemotherapy receipt among subgroups defined by tumor size, histology, presence of lymphovascular space invasion, surgical approach, or receipt of adjuvant brachytherapy. Conclusions and Relevance The results of this cohort study suggest that adding chemotherapy to radiotherapy was not associated with improved overall survival for patients with intermediate-risk cervical cancer.
Effect of High-Intensity vs Low-Intensity Noninvasive Positive Pressure Ventilation on the Need for Endotracheal Intubation
Authors: Joseph R. Shiber
Journal: JAMA (2025)

Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy | Continue JAMA HomeNew OnlineCurrent IssueFor Authors JAMA+ AI Journals JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry (1919-1959) Podcasts Clinical Reviews Editors' Summary Medical News Author Interviews More JN Learning / CMESubscribeJobsInstitutions / LibrariansReprints & Permissions Terms of Use | Privacy Policy | Accessibility Statement 2025 American Medical Association. All Rights Reserved Search All JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Forum Archive JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry Input Search Term Sign In Individual Sign In Sign inCreate an Account Access through your institution Sign In Purchase Options: Buy this article Rent this article Subscribe to the JAMA journal
Veliparib Plus Temozolomide for <i>MGMT</i>-Methylated Glioblastoma
Authors: Liam Wilson, Aline Atallah
Journal: JAMA Oncology (2025)

Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy | Continue JAMA Oncology HomeNew OnlineCurrent IssueFor Authors Podcast JAMA+ AI Journals JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry (1919-1959) JN Learning / CMESubscribeJobsInstitutions / LibrariansReprints & Permissions Terms of Use | Privacy Policy | Accessibility Statement 2025 American Medical Association. All Rights Reserved Search All JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Forum Archive JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry Input Search Term Sign In Individual Sign In Sign inCreate an Account Access through your institution Sign In Purchase Options: Buy this article Rent this article Subscribe to the JAMA Oncology journal
A common longitudinal intensive care unit data format (CLIF) for critical illness research
Authors: Juan C. Rojas, Patrick G. Lyons, Kaveri Chhikara, Vaishvik Chaudhari, Sivasubramanium V. Bhavani, Muna Nour, Kevin G. Buell, Kevin D. Smith, Catherine A. Gao, Saki Amagai, Chengsheng Mao, Yuan Luo, Anna K. Barker, Mark Nuppnau, Michael Hermsen, Jay L. Koyner, Haley Beck, Rachel Baccile, Zewei Liao, Kyle A. Carey, Brenna Park-Egan, Xuan Han, Alexander C. Ortiz, Benjamin E. Schmid, Gary E. Weissman, Chad H. Hochberg, Nicholas E. Ingraham, William F. Parker
Journal: Intensive Care Medicine (2025)
Cancer Mortality Rates in Female Veterans With and Without TBI
Authors: Christin B. DeStefano, Kelly Cheever, Jeffrey T. Howard, Megan Amuan, Ian J. Stewart, Mary Jo Pugh
Journal: JAMA Network Open (2025)

This cohort study compares cancer mortality rates of female veterans with and without traumatic brain injury (TBI) who served after September 11, 2001, with rates among the general female population of the US.
Affording Childcare on a Surgical Resident’s Salary
Authors: Margaret G. Mercante, Emily G. Tocco, Nidhi Kuchimanchi, Mohamad El Moheb, Maria F. Nunez, Mackenzie M. Mayhew, Susan J. Kim, Allan Tsung, Lily S. Cheng, Russell G. Witt
Journal: JAMA Network Open (2025)

Importance Previously published literature found that 28.6% of surgical residents have or are expecting children, yet little information exists regarding the financial demands of childcare during residency. Objective To evaluate surgical residents’ net financial balance after childcare costs at various postgraduate years and child ages. Design, Setting, and Participants This cross-sectional study, conducted from June 14 to August 2, 2024, examined surgical residency programs across the US using publicly available data. Programs were categorized into US regions based on the Association of American Medical Colleges classifications: Northeast, Midwest, South, and West. Childcare costs were obtained from the National Database of Childcare Prices, and annual expenditure data came from the Bureau of Labor Statistics. Main Outcomes and Measures The primary outcome was residents’ net income by year of residency, calculated using salaries and expenditures. To compare costs by region and child age, net income was determined by subtracting mean expenditures and childcare costs from residency salaries. Calculations were validated using the Massachusetts Institute of Technology Living Wage Calculator. Results Of 351 US surgical residency programs, 295 with publicly available salaries for postgraduate years 1 through 5 met inclusion criteria. A total of 290 programs (98.3%) showed a negative net income when expenditures and childcare costs were deducted. This finding held true across all child age groups and US regions. The West had the most negative mean net income (−$18 852 [range, –$35 726 to $766]), followed by the Northeast (–$15 878 [range, –$37 310 to $3589]), Midwest (–$12 067 [range, –$26 111 to $1614]), and South (–$8636 [range, –$18 740 to $4826]). Parents of school-aged children in the South had the lowest mean negative net income (−$8453 [range, −$16 377 to $3417]), while parents of infants in the West had the highest mean negative net income (−$21 278 [range, −$35 726 to −$5112]). Conclusions and Relevance This cross-sectional study of surgical residents’ net income found that, after accounting for mean annual expenditures and childcare costs, a surgical resident’s salary was insufficient to cover living expenses and childcare costs for single resident parents. This financial obstacle may deter individuals from pursuing surgical residency or from starting families as surgical residents.
Effective targeting of PDGFRA-altered high-grade glioma with avapritinib
Authors: Lisa Mayr, Sina Neyazi, Kallen Schwark, Maria Trissal, Alexander Beck, Jenna Labelle, Sebastian K Eder, Liesa Weiler-Wichtl, Joana G Marques, Carlos A O de Biagi-Junior, Costanza Lo Cascio, Owen Chapman, Sunita Sridhar, Rishaan Kenkre, Aditi Dutta, Shanqing Wang, Jessica Wang, Olivia Hack, Andrezza Nascimento, Cuong M Nguyen, Sophia Castellani, Jacob S Rozowsky, Andrew Groves, Eshini Panditharatna, Gustavo Alencastro Veiga Cruzeiro, Rebecca D Haase, Kuscha Tabatabai, Sibylle Madlener, Jack Wadden, Tiffany Adam, Seongbae Kong, Madeline Miclea, Tirth Patel, Katharina Bruckner, Daniel Senfter, Anna Lämmerer, Jeffrey Supko, Armin S Guntner, Hana Palova, Jakub Neradil, Natalia Stepien, Daniela Lötsch-Gojo, Walter Berger, Ulrike Leiss, Verena Rosenmayr, Christian Dorfer, Karin Dieckmann, Andreas Peyrl, Amedeo A Azizi, Alicia Baumgartner, Ondrej Slaby, Petra Pokorna, Louise M Clark, Amy Cameron, Quang-De Nguyen, Hiroaki Wakimoto, Frank Dubois, Noah F Greenwald, Pratiti Bandopadhayay, Rameen Beroukhim, Keith Ligon, Christof Kramm, Annika Bronsema, Simon Bailey, Ana Guerreiro Stucklin, Sabine Mueller, Mary Skrypek, Nina Martinez, Daniel C Bowers, David T W Jones, Chris Jones, Natalie Jäger, Jaroslav Sterba, Leonhard Müllauer, Christine Haberler, Chandan Kumar-Sinha, Arul Chinnaiyan, Rajen Mody, Lukas Chavez, Julia Furtner, Carl Koschmann, Johannes Gojo, Mariella G Filbin
Journal: Cancer Cell (2025)
Distinct CD8+ T cell dynamics associate with response to neoadjuvant cancer immunotherapies
Authors: Housaiyin Li, Dan P Zandberg, Aditi Kulkarni, Simion I Chiosea, Patricia M Santos, Brian R Isett, Marion Joy, Gabriel L Sica, Kevin J Contrera, Curtis M Tatsuoka, Matthias Brand, Umamaheswar Duvvuri, Seungwon Kim, Mark Kubik, Shaum Sridharan, Fei Tu, Jie Chen, Tullia C Bruno, Dario A A Vignali, Anthony R Cillo, Riyue Bao, Jing Hong Wang, Lazar Vujanovic, Robert L Ferris
Journal: Cancer Cell (2025)
Late adverse event reporting from medical device manufacturers to the US Food and Drug Administration: cross sectional study
Authors: Alexander O Everhart, Pinar Karaca-Mandic, Rita F Redberg, Joseph S Ross, Sanket S Dhruva
Journal: BMJ (2025)

Abstract Objective To describe the extent of late adverse event reporting by manufacturers to the US Food and Drug Administration’s (FDA) Manufacturer And User Facility Device Experience (MAUDE) database as well as the distribution of late reporting among manufacturers and associations with device characteristics. Design Cross sectional study. Setting The FDA MAUDE database, a central postmarket safety surveillance tool for US medical devices, from 1 September 2019 to 31 December 2022. Participants Medical device manufacturers that submitted initial adverse event reports to the FDA between 1 September 2019 and 31 December 2022. Main outcome measures Time in days between date manufacturer was notified of event and date of FDA receipt of adverse event reports, proportion of reports reported late (after the required 30 day window as required by FDA regulation), and distribution of late reporting among manufacturers and medical devices. Results 13 587 reports were of deaths, 1 552 268 of injuries, and 2 866 693 of malfunctions received by the FDA from 3028 unique manufacturers and 88 448 unique medical devices in the three and a half year period. Of 4 432 548 included reports, 71.0% (n=3 146 957) of adverse events were reported within 30 days (on time), 4.5% (n=197 606) were reported between 31 and 180 days (late), and 9.1% (n=402 891) were after 180 days (late). 15.5% of reports (n=685 094) had missing or invalid date data provided by the manufacturer. Three manufactures and 13 medical devices were attributed to 54.8% of late reports. Conclusions Nearly a third of manufacturer reports of medical device adverse events were not demonstrably submitted to the FDA within the regulatory deadline, with most late reports being submitted more than six months after manufacturer notification. Most late reports were submitted by a small number of manufacturers. Late adverse event reporting may prevent early detection of patient safety concerns.