PubMed 문헌

PubMed

United States Food and Drug Administration Approval of Neurosurgical Devices: A 25-Year Review of Non-510(k) Pathway Trends.

학술지 World neurosurgery

날짜 2026-07-08

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PubMed

Innovation trajectory of Software as a Medical Device: Evidence from the US FDA-approved products.

학술지 Digital health

날짜 2026-06-29

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PubMed

Pre-market clinical investigation approval pathways and the role of Early Feasibility Studies for medical devices: a scoping review to guide EU policy.

학술지 Expert review of medical devices

날짜 2026-06-25

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PubMed

Radiation Oncology Device Recalls (2015-2025): Software and Artificial Intelligence as Emerging Drivers of Postmarket Safety.

학술지 Practical radiation oncology

날짜 2026-06-22

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PubMed

Patient Preference Information (PPI) in Medical Device Development: A Cross-Industry Review of Use-Cases.

학술지 Therapeutic innovation & regulatory science

날짜 2026-06-20

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PubMed

Regulating digital surgery to balance safety and innovation: a SAGES white paper.

학술지 Surgical endoscopy

날짜 2026-06-19

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PubMed

Two decades of growth and trends in the FDA authorization of digital medical devices.

학술지 NPJ digital medicine

날짜 2026-06-17

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PubMed

우로로지에서 인공지능: 미국 식품의약국(FDA) 승인된 장비 리뷰

학술지 BJU international

날짜 2026-06-16

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PubMed

Borrowing from the cancer playbook: a master protocol basket trial for hard-to-heal wound therapeutics targeting shared pathobiology.

학술지 Journal of wound care

날짜 2026-06-15

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PubMed

미국 의료 장비 규제의 역사와 현재 규제 프레임워크

학술지 JBJS reviews

날짜 2026-06-15

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PubMed

Reliability and Consistency Analysis of Multiple Instruments for Scoliosis Screening in Adolescent Males: A Comparative Study of Instrument Accuracy.

학술지 Studies in health technology and informatics

날짜 2026-06-15

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PubMed

Regulatory science for AI-based software as a medical device in computational pathology and biomarker-driven drug development.

학술지 Journal of pathology informatics

날짜 2026-06-11

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