Medical Device Adverse Events, Errors, Safety

Trends in South Korean Medical Device Development for Attention-Deficit/Hyperactivity Disorder and Autism Spectrum Disorder: Narrative Review

Yunah Cho, Sharon L Talboys

JMIR Biomed Eng 2024 (Oct 15); 9:e60399

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Impact of Skin Pigmentation on Pulse Oximetry Blood Oxygenation and Wearable Pulse Rate Accuracy: Systematic Review and Meta-Analysis

Sanidhya Singh, Miles Romney Bennett, Chen Chen, Sooyoon Shin, Hamid Ghanbari, Benjamin W Nelson

J Med Internet Res 2024 (Oct 10); 26:e62769

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Racial Biases Associated With Pulse Oximetry: Longitudinal Social Network Analysis of Social Media Advocacy Impact

Wasim Ahmed, Mariann Hardey, Bradford David Winters, Aarti Sarwal

J Med Internet Res 2024 (Oct 08); 26:e56034

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Development of Automated Triggers in Ambulatory Settings in Brazil: Protocol for a Machine Learning–Based Design Thinking Study

Claire Nierva Herrera, Fernanda Raphael Escobar Gimenes, João Paulo Herrera, Ricardo Cavalli

JMIR Res Protoc 2024 (Aug 12); 13:e55466

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Assessing the Accuracy of Smartwatch-Based Estimation of Maximum Oxygen Uptake Using the Apple Watch Series 7: Validation Study

Polona Caserman, Sungsoo Yum, Stefan Göbel, Andreas Reif, Silke Matura

JMIR Biomed Eng 2024 (Jul 31); 9:e59459

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Insights From a Clinically Orientated Workshop on Health Care Cybersecurity and Medical Technology: Observational Study and Thematic Analysis

Isabel Straw, Irina Brass, Andrew Mkwashi, Inika Charles, Amelie Soares, Caroline Steer

J Med Internet Res 2024 (Jul 11); 26:e50505

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AI as a Medical Device Adverse Event Reporting in Regulatory Databases: Protocol for a Systematic Review

Aditya U Kale, Riya Dattani, Ashley Tabansi, Henry David Jeffry Hogg, Russell Pearson, Ben Glocker, Su Golder, Justin Waring, Xiaoxuan Liu, David J Moore, Alastair K Denniston

JMIR Res Protoc 2024 (Jul 11); 13:e48156

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Detecting Algorithmic Errors and Patient Harms for AI-Enabled Medical Devices in Randomized Controlled Trials: Protocol for a Systematic Review

Aditya U Kale, Henry David Jeffry Hogg, Russell Pearson, Ben Glocker, Su Golder, April Coombe, Justin Waring, Xiaoxuan Liu, David J Moore, Alastair K Denniston

JMIR Res Protoc 2024 (Jun 28); 13:e51614

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Characterizing and Comparing Adverse Drug Events Documented in 2 Spontaneous Reporting Systems in the Lower Mainland of British Columbia, Canada: Retrospective Observational Study

Erica Y Lau, Amber Cragg, Serena S Small, Katherine Butcher, Corinne M Hohl

JMIR Hum Factors 2024 (Jan 18); 11:e52495

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An Agreement of Antigen Tests on Oral Pharyngeal Swabs or Less Invasive Testing With Reverse Transcription Polymerase Chain Reaction for Detecting SARS-CoV-2 in Adults: Protocol for a Prospective Nationwide Observational Study

Uffe Vest Schneider, Jenny Dahl Knudsen, Anders Koch, Nikolai Søren Kirkby, Jan Gorm Lisby

JMIR Res Protoc 2022 (May 04); 11(5):e35706

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Using Postmarket Surveillance to Assess Safety-Related Events in a Digital Rehabilitation App (Kaia App): Observational Study

Deeptee Jain, Kevin Norman, Zachary Werner, Bar Makovoz, Turner Baker, Stephan Huber

JMIR Hum Factors 2021 (Nov 09); 8(4):e25453

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Tracking the Presence of Software as a Medical Device in US Food and Drug Administration Databases: Retrospective Data Analysis

Aaron Ceross, Jeroen Bergmann

JMIR Biomed Eng 2021 (Nov 03); 6(4):e20652

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Effectiveness of the BreatheSuite Device in Assessing the Technique of Metered-Dose Inhalers: Validation Study

Meshari F Alwashmi, Gerald Mugford, Brett Vokey, Waseem Abu-Ashour, John Hawboldt

JMIR Biomed Eng 2021 (Nov 03); 6(4):e26556

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Wearable Bioimpedance Monitoring: Viewpoint for Application in Chronic Conditions

Willemijn Groenendaal, Seulki Lee, Chris van Hoof

JMIR Biomed Eng 2021 (May 11); 6(2):e22911

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Rhythmic Haptic Cueing for Gait Rehabilitation of People With Hemiparesis: Quantitative Gait Study

Theodoros Georgiou, Simon Holland, Janet van der Linden

JMIR Biomed Eng 2020 (Nov 24); 5(1):e18649

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Modular Catheter Systems in Minimally Invasive Interventional Medical Procedures: Case Study

Bradley Beach, Brian A Scansen

JMIR Biomed Eng 2019 (Jul 29); 4(1):e14443

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Wireless Surface Electromyography and Skin Temperature Sensors for Biofeedback Treatment of Headache: Validation Study with Stationary Control Equipment

Anker Stubberud, Petter Moe Omland, Erling Tronvik, Alexander Olsen, Trond Sand, Mattias Linde

JMIR Biomed Eng 2018 (Feb 23); 3(1):e1

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