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PubMed-Literatur

Publikationen zu Medizinprodukten aus PubMed / NCBI

PubMed

Ein Fallstudie über AI-gesteuerte Software als medizinisches Gerät, das von der FDA zur Bewertung des Risikos eines Blutverlusts nach einem Trauma (APPRAISE-HRI) genehmigt wurde.

Zeitschrift NEJM AI

Datum 2025-10-16

PubMed

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

Zeitschrift Expert review of medical devices

Datum 2025-10-14

PubMed

Navigating through regulatory frameworks for digital therapeutics and biomarkers.

Zeitschrift Health informatics journal

Datum 2025-10-09

PubMed

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

Zeitschrift Cureus

Datum 2025-10-08

PubMed

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

Zeitschrift Therapeutic innovation & regulatory science

Datum 2025-10-07

PubMed

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

Zeitschrift Therapie

Datum 2025-10-06

PubMed

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

Zeitschrift Journal of medical Internet research

Datum 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).

Zeitschrift The Journal of the American Academy of Orthopaedic Surgeons

Datum 2025-09-24

PubMed

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

Zeitschrift npj health systems

Datum 2025-09-16

PubMed

The Essential Role of Medical Monitors in Clinical Trials.

Zeitschrift Cureus

Datum 2025-09-15

PubMed

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

Zeitschrift Resuscitation plus

Datum 2025-09-11

PubMed

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

Zeitschrift JAMA health forum

Datum 2025-09-05

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