Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

Literatura de PubMed

Publicaciones sobre dispositivos médicos de PubMed / NCBI

PubMed

US regulatory considerations for low field magnetic resonance imaging systems.

Revista Magma (New York, N.Y.)

Fecha 2023-05-16

PubMed

Multicenter Clinical Performance Evaluation of Omadacycline Susceptibility Testing of Enterobacterales on VITEK 2 Systems.

Revista Journal of clinical microbiology

Fecha 2023-05-10

PubMed

FDA regulations and prescription digital therapeutics: Evolving with the technologies they regulate.

Revista Frontiers in digital health

Fecha 2023-04-17

PubMed

Artificial intelligence in medicine - dermatology compared to other medical specialties in FDA-cleared software as medical device.

Revista Dermatology online journal

Fecha 2023-04-15

PubMed

Risk of Recall Associated With Modifications to High-risk Medical Devices Approved Through US Food and Drug Administration Supplements.

Revista JAMA network open

Fecha 2023-04-03

PubMed

Identification of predicate creep under the 510(k) process: A case study of a robotic surgical device.

Revista PloS one

Fecha 2023-03-28

PubMed

Bayesian Statistics for Medical Devices: Progress Since 2010.

Revista Therapeutic innovation & regulatory science

Fecha 2023-03-03

PubMed

UN ANÁLISIS NO TRIVIAL DEL RIESGO DE SEGURIDAD DEL PACIENTE DE ENTOXINAS DE MEDICAMENTOS INYECTABLES Y DISPOSITIVOS MÉDICOS.

Revista Drugs in R&D

Fecha 2023-02-24

PubMed

Regulatory scripting: Stakeholder participation in food and drug administration medical device advisory meetings.

Revista PloS one

Fecha 2023-02-16

PubMed

Propensity score-based methods for causal inference and external data leveraging in regulatory settings: From basic ideas to implementation.

Revista Pharmaceutical statistics

Fecha 2023-02-16

PubMed

Review of approvals and recalls of US specific medical devices in general and plastic surgery.

Revista Surgery in practice and science

Fecha 2023-02-15

PubMed

Market competition among manufacturers of novel high-risk therapeutic devices receiving FDA premarket approval between 2001 and 2018.

Revista BMJ surgery, interventions, & health technologies

Fecha 2023-02-08

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