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

Un caso de estudio de un software habilitado por IA como dispositivo médico aprobado por la FDA para evaluar el índice de riesgo de hemorragia (APPRAISE-HRI) después del trauma.

Revista NEJM AI

Fecha 2025-10-16

PubMed

Software as Medical Devices: requirements and regulatory landscape in the United States.

Revista Expert review of medical devices

Fecha 2025-10-14

PubMed

Navigating through regulatory frameworks for digital therapeutics and biomarkers.

Revista Health informatics journal

Fecha 2025-10-09

PubMed

Evaluation of a Single Knee System: All-Polyethylene Tibia (APT) vs. Metal-Backed Tibia (MBT) in Primary Total Knee Arthroplasty.

Revista Cureus

Fecha 2025-10-08

PubMed

Regulatory Adoption of AI, ML, Computational Modeling & Simulation in In-Silico Clinical Trials for Medical Devices: A Systematic Review.

Revista Therapeutic innovation & regulatory science

Fecha 2025-10-07

PubMed

Artificial intelligence in personalized prescription: A narrative review of promise, peril, and practicality.

Revista Therapie

Fecha 2025-10-06

PubMed

Stakeholder Perspectives on Early Feasibility Studies for Digital Health Technologies in the European Union: Qualitative Interview Study.

Revista Journal of medical Internet research

Fecha 2025-10-01

PubMed

Recalls of Arthroscopic Equipment After Food and Drug Administration 510(k) Approval: A Twenty-Year Analysis of Causes, Trends, and Time to Recall (2004 to 2024).

Revista The Journal of the American Academy of Orthopaedic Surgeons

Fecha 2025-09-24

PubMed

Competitive value of acquiring novel FDA product codes for medical device manufacturers: an original investigation.

Revista npj health systems

Fecha 2025-09-16

PubMed

The Essential Role of Medical Monitors in Clinical Trials.

Revista Cureus

Fecha 2025-09-15

PubMed

Clearing the airway? A pilot cadaveric study of the LifeVac™ device.

Revista Resuscitation plus

Fecha 2025-09-11

PubMed

Benefit-Risk Reporting for FDA-Cleared Artificial Intelligence-Enabled Medical Devices.

Revista JAMA health forum

Fecha 2025-09-05

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