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PubMed-Literatur

Publikationen zu Medizinprodukten aus PubMed / NCBI

PubMed

US regulatory considerations for low field magnetic resonance imaging systems.

Zeitschrift Magma (New York, N.Y.)

Datum 2023-05-16

PubMed

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

Zeitschrift Journal of clinical microbiology

Datum 2023-05-10

PubMed

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

Zeitschrift Frontiers in digital health

Datum 2023-04-17

PubMed

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

Zeitschrift Dermatology online journal

Datum 2023-04-15

PubMed

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

Zeitschrift JAMA network open

Datum 2023-04-03

PubMed

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

Zeitschrift PloS one

Datum 2023-03-28

PubMed

Bayesian Statistics for Medical Devices: Progress Since 2010.

Zeitschrift Therapeutic innovation & regulatory science

Datum 2023-03-03

PubMed

EINE NACHTRÄGLICHE ANALYSE DER PATIENTENSICHERHEITSGEFÄHR VON parenteralen DRUG- UND MEDIZINISCHEN GERÄT-TRÄGENDEN ENZOTOXIN.

Zeitschrift Drugs in R&D

Datum 2023-02-24

PubMed

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

Zeitschrift PloS one

Datum 2023-02-16

PubMed

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

Zeitschrift Pharmaceutical statistics

Datum 2023-02-16

PubMed

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

Zeitschrift Surgery in practice and science

Datum 2023-02-15

PubMed

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

Zeitschrift BMJ surgery, interventions, & health technologies

Datum 2023-02-08

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