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Regulatory Insights From 27 Years of Artificial Intelligence/Machine Learning–Enabled Medical Device Recalls in the United States: Implications for Future Governance

Regulatory Insights From 27 Years of Artificial Intelligence/Machine Learning–Enabled Medical Device Recalls in the United States: Implications for Future Governance

The Guidance of Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C mentions referencing 21 CFR 820.100(a)(2), which requires procedures for implementing corrections or preventive actions to include an investigation of the causes for nonconformities related to the product, processes, and quality systems.

Wei-Pin Chen, Wei-Guang Teng, C Benson Kuo, Yu-Jui Yen, Jian-Yu Lian, Matthew Sing, Peng-Ting Chen

JMIR Med Inform 2025;13:e67552

AI Predictive Model of Mortality and Intensive Care Unit Admission in the COVID-19 Pandemic: Retrospective Population Cohort Study of 12,000 Patients

AI Predictive Model of Mortality and Intensive Care Unit Admission in the COVID-19 Pandemic: Retrospective Population Cohort Study of 12,000 Patients

The most important features are a high extension in pulmonary infiltrate in the radiology report, tachypnea, LDH, BMI, C-reactive protein, and leukocyte. Features such as creatinine, EDW, and procalcitonin have ambiguous interpretations, as both low and high values contribute to the prediction. Figure 8 provides an example of this behavior for EDW.

Jose Manuel Ruiz Giardin, Óscar Garnica, Nieves Mesa Plaza, Juan Víctor SanMartín López, Ana Farfán Sedano, Elena Madroñal Cerezo, Miguel Ángel Duarte Millán, Aida Izquierdo Martínez, Luis Rivas, Marta Rivilla, Alejandro Morales Ortega, Begoña Frutos Pérez, Cristina De Ancos Aracil, Ruth Calderón, Guillermo Soria Fernandez, Jorge Marrero Francés, David Bernal Bello, Jose Ángel Satué Bartolomé, María Toledano Macías, Sara Piedrabuena García, Marta Guerrero Santillán, Rafael Cristóbal, Belen Mora, Laura Velázquez Ríos, Vanesa García de Viedma, Paula Cuenca Ruiz, Ibone Ayala Larrañaga, Lorena Carpintero, Celia Lara, Alvaro Ricardo Llerena, Virginia García Bermúdez, Gema Delgado Cárdenas, Paloma Pardo Rovira, Elena Tejero Sánchez, Maria Jesús Domínguez García, Carolina Mariño, Cristina Bravo, Ana Ontañon, Mario García, Jose Ignacio Hidalgo Pérez, Santiago Prieto Menchero, Natalia González Pereira, Sonia Gonzalo Pascua, Jorge Tarancón Rey, Luis Antonio Lechuga Suárez, FUENCOVID

J Med Internet Res 2025;27:e70674