PubMed 문헌

PubMed

A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma.

학술지 NEJM AI

날짜 2025-10-16

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PubMed

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

학술지 Expert review of medical devices

날짜 2025-10-14

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PubMed

Navigating through regulatory frameworks for digital therapeutics and biomarkers.

학술지 Health informatics journal

날짜 2025-10-09

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PubMed

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

학술지 Cureus

날짜 2025-10-08

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PubMed

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

학술지 Therapeutic innovation & regulatory science

날짜 2025-10-07

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PubMed

개인 맞춤형 처방에서 인공지능: 약속, 위험, 실용성에 대한 이야기 리뷰

학술지 Therapie

날짜 2025-10-06

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PubMed

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

학술지 Journal of medical Internet research

날짜 2025-10-01

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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).

학술지 The Journal of the American Academy of Orthopaedic Surgeons

날짜 2025-09-24

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PubMed

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

학술지 npj health systems

날짜 2025-09-16

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PubMed

The Essential Role of Medical Monitors in Clinical Trials.

학술지 Cureus

날짜 2025-09-15

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PubMed

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

학술지 Resuscitation plus

날짜 2025-09-11

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PubMed

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

학술지 JAMA health forum

날짜 2025-09-05

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