Suchergebnisse - "Medical device"

"Appropriateness" of Clinical Data Under Regulation (EU) 2017/745- A Case Study and Survey.

Autoren: Oltmanns E D'Agosto M Spitzenberger F

Quelle: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2025 Nov; Vol. 59 (6), pp. 1356-1368. Date of Electronic Publication: 2025 Jul 03.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE

MeSH-Schlagworte: Device Approval*/legislation & jurisprudence , Medical Device Legislation* , Equipment and Supplies*, Humans ; Surveys and Questionnaires ; European Union

Medical device shelf-life and recalls: navigating healthcare challenges.

Autoren: Thakor P Shah S Shah A et al.

Quelle: Expert review of medical devices [Expert Rev Med Devices] 2025 Dec; Vol. 22 (12), pp. 1391-1401. Date of Electronic Publication: 2025 Oct 21.

Publikationsart: Journal Article; Review

Info zur Zeitschrift: Publisher: Taylor & Francis Country of Publication: England NLM ID: 101230445 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1745-2422 (Electronic) Linking ISSN: 17434440 NLM ISO Abbreviation: Expert Rev Med Devices Subsets: MEDLINE

MeSH-Schlagworte: Equipment and Supplies* , Medical Device Recalls*, Humans ; United States ; United States Food and Drug Administration ; Patient Safety

In vitro diagnostic devices need a robust regulatory framework.

Autoren: Herd GC Musaad SM

Quelle: The New Zealand medical journal [N Z Med J] 2025 Nov 21; Vol. 138 (1626), pp. 81-88. Date of Electronic Publication: 2025 Nov 21.

Publikationsart: Journal Article; Review

Info zur Zeitschrift: Publisher: Pasifika Medical Association Group Country of Publication: New Zealand NLM ID: 0401067 Publication Model: Electronic Cited Medium: Internet ISSN: 1175-8716 (Electronic) Linking ISSN: 00288446 NLM ISO Abbreviation: N Z Med J Subsets: MEDLINE

MeSH-Schlagworte: Point-of-Care Testing*/legislation & jurisprudence , Point-of-Care Testing*/standards , Device Approval*/legislation & jurisprudence , Medical Device Legislation*, New Zealand ; Humans ; Patient Safety

Bridging the gap: a paradigm shift in medical device regulations in India.

Autoren: Pundir D Kaur S Kaur R et al.

Quelle: Naunyn-Schmiedeberg's archives of pharmacology [Naunyn Schmiedebergs Arch Pharmacol] 2025 Oct; Vol. 398 (10), pp. 13265-13275. Date of Electronic Publication: 2025 Apr 28.

Publikationsart: Journal Article; Review

Info zur Zeitschrift: Publisher: Springer Verlag Country of Publication: Germany NLM ID: 0326264 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1432-1912 (Electronic) Linking ISSN: 00281298 NLM ISO Abbreviation: Naunyn Schmiedebergs Arch Pharmacol Subsets: MEDLINE

MeSH-Schlagworte: Medical Device Legislation* , Equipment and Supplies*/standards , Device Approval*/legislation & jurisprudence, India ; Humans

FDA Recalls of Image Guidance Systems for Sinus and Skull Base Surgery, 2003-2024.

Autoren: Rajan T Schlosser RJ Soler ZM et al.

Quelle: International forum of allergy & rhinology [Int Forum Allergy Rhinol] 2025 Oct; Vol. 15 (10), pp. 1028-1031. Date of Electronic Publication: 2025 May 14.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: Published for ARS-AAOA by Wiley-Blackwell Country of Publication: United States NLM ID: 101550261 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2042-6984 (Electronic) Linking ISSN: 20426976 NLM ISO Abbreviation: Int Forum Allergy Rhinol Subsets: MEDLINE

MeSH-Schlagworte: Skull Base*/surgery , Skull Base*/diagnostic imaging , Medical Device Recalls* , Paranasal Sinuses*/surgery , Paranasal Sinuses*/diagnostic imaging , Surgery, Computer-Assisted*/instrumentation, United States ; United States Food and Drug Administration ; Humans ; Cross-Sectional Studies

Evidence-based recommendations for comprehensive regulatory guidelines in medical devices: the imperative for global harmonization.

Autoren: Rimpi Verma SJ Pinky et al.

Quelle: Naunyn-Schmiedeberg's archives of pharmacology [Naunyn Schmiedebergs Arch Pharmacol] 2025 Jul; Vol. 398 (7), pp. 7697-7711. Date of Electronic Publication: 2025 Feb 05.

Publikationsart: Journal Article; Review

Info zur Zeitschrift: Publisher: Springer Verlag Country of Publication: Germany NLM ID: 0326264 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1432-1912 (Electronic) Linking ISSN: 00281298 NLM ISO Abbreviation: Naunyn Schmiedebergs Arch Pharmacol Subsets: MEDLINE

MeSH-Schlagworte: Equipment and Supplies*/standards , Device Approval*/legislation & jurisprudence , Medical Device Legislation*/standards , Guidelines as Topic*, Humans ; International Cooperation

Regulatory Insights From 27 Years of Artificial Intelligence/Machine Learning-Enabled Medical Device Recalls in the United States: Implications for Future Governance.

Autoren: Chen WP Teng WG Kuo CB et al.

Quelle: JMIR medical informatics [JMIR Med Inform] 2025 Jul 11; Vol. 13, pp. e67552. Date of Electronic Publication: 2025 Jul 11.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: JMIR Publications Country of Publication: Canada NLM ID: 101645109 Publication Model: Electronic Cited Medium: Internet ISSN: 2291-9694 (Electronic) Linking ISSN: 22919694 NLM ISO Abbreviation: JMIR Med Inform Subsets: MEDLINE

MeSH-Schlagworte: Machine Learning* , Medical Device Recalls*/legislation & jurisprudence , Artificial Intelligence*, United States ; United States Food and Drug Administration ; Humans ; Device Approval/legislation & jurisprudence

[Regulatory classification of AI-enabled products for medical use on the basis of the EU AI Act and MDR/IVDR].

Transliterierter Titel: Regulatorische Einordnung KI-basierter Produkte für die medizinische Anwendung auf Basis von EU AI Act und MDR/IVDR.

Autoren: Luckner S Lauer W

Quelle: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz [Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz] 2025 Aug; Vol. 68 (8), pp. 854-861. Date of Electronic Publication: 2025 Jul 04.

Publikationsart: English Abstract; Journal Article; Review

Info zur Zeitschrift: Publisher: Springer Country of Publication: Germany NLM ID: 101181368 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1437-1588 (Electronic) Linking ISSN: 14369990 NLM ISO Abbreviation: Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz Subsets: MEDLINE

MeSH-Schlagworte: Artificial Intelligence*/legislation & jurisprudence , Device Approval*/legislation & jurisprudence , Medical Device Legislation* , Equipment and Supplies*/classification , Equipment Safety*/classification, European Union ; Germany ; Europe ; Humans

Regulating the future of laboratory medicine: European regulatory landscape of AI-driven medical device software in laboratory medicine.

Autoren: Çubukçu HC Boursier G Linko S et al.

Körperschaften: Çubukçu HC Boursier G Linko S et al.

Quelle: Clinical chemistry and laboratory medicine [Clin Chem Lab Med] 2025 May 28; Vol. 63 (10), pp. 1891-1914. Date of Electronic Publication: 2025 May 28 (Print Publication: 2025).

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: Walter De Gruyter Country of Publication: Germany NLM ID: 9806306 Publication Model: Electronic-Print Cited Medium: Internet ISSN: 1437-4331 (Electronic) Linking ISSN: 14346621 NLM ISO Abbreviation: Clin Chem Lab Med Subsets: MEDLINE

MeSH-Schlagworte: Artificial Intelligence* , Medical Device Legislation* , Software*, Humans ; Europe

Chemical Characterization in Medical Device Evaluation: Current Practices, Regulatory Requirements, and Future Directions.

Autoren: Szymanski L Kiernozek M Gromadka B et al.

Quelle: Annals of biomedical engineering [Ann Biomed Eng] 2025 May; Vol. 53 (5), pp. 1068-1079. Date of Electronic Publication: 2025 Mar 04.

Publikationsart: Journal Article; Review

Info zur Zeitschrift: Publisher: Springer Science + Business Media Country of Publication: United States NLM ID: 0361512 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-9686 (Electronic) Linking ISSN: 00906964 NLM ISO Abbreviation: Ann Biomed Eng Subsets: MEDLINE

MeSH-Schlagworte: Equipment and Supplies*/standards , Device Approval*/legislation & jurisprudence , Medical Device Legislation* , Equipment Safety*/standards, Humans ; United States

[Impact of the European Medical Device Regulation on the availability of medical devices: Scoping review and two-year analysis on the risk for patients in the cardiovascular field].

Transliterierter Titel: Impact du Règlement Européen sur les dispositifs médicaux sur leur disponibilité : scoping review et analyse sur deux ans du risque pour les patients dans le domaine cardiovasculaire.

Autoren: Bonan A Huynh S Pineau J et al.

Quelle: Annales pharmaceutiques francaises [Ann Pharm Fr] 2025 May; Vol. 83 (3), pp. 428-437. Date of Electronic Publication: 2025 Jan 28.

Publikationsart: Journal Article; Scoping Review; English Abstract

Info zur Zeitschrift: Publisher: Elsevier Masson Editeur Country of Publication: France NLM ID: 2985176R Publication Model: Print-Electronic Cited Medium: Internet ISSN: 0003-4509 (Print) Linking ISSN: 00034509 NLM ISO Abbreviation: Ann Pharm Fr Subsets: MEDLINE

MeSH-Schlagworte: Equipment and Supplies*/supply & distribution , Medical Device Legislation* , Cardiovascular Diseases*/therapy, Humans ; Europe ; Device Approval/legislation & jurisprudence

Evaluating the Impact of the EU AI Act on Medical Device Regulation.

Autoren: Kalodanis K Feretzakis G Rizomiliotis P et al.

Quelle: Studies in health technology and informatics [Stud Health Technol Inform] 2025 Apr 08; Vol. 323, pp. 40-44.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: IOS Press Country of Publication: Netherlands NLM ID: 9214582 Publication Model: Print Cited Medium: Internet ISSN: 1879-8365 (Electronic) Linking ISSN: 09269630 NLM ISO Abbreviation: Stud Health Technol Inform Subsets: MEDLINE

MeSH-Schlagworte: Artificial Intelligence*/legislation & jurisprudence , Medical Device Legislation* , Equipment and Supplies*/standards , Equipment Safety*/standards , Device Approval*/legislation & jurisprudence, European Union ; Humans

The Fall Out of the 2017 European Medical Device Regulation for Tracheal Occlusion.

Autoren: Russo F Benachi A Meijer F et al.

Quelle: Prenatal diagnosis [Prenat Diagn] 2025 Apr; Vol. 45 (4), pp. 539-543. Date of Electronic Publication: 2025 Mar 15.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: Wiley Country of Publication: England NLM ID: 8106540 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1097-0223 (Electronic) Linking ISSN: 01973851 NLM ISO Abbreviation: Prenat Diagn Subsets: MEDLINE

MeSH-Schlagworte: Fetoscopy*/instrumentation , Balloon Occlusion*/instrumentation , Medical Device Legislation*, Humans ; Europe ; Female ; Pregnancy ; Trachea/surgery

Do Specialized Medical LLMs Demand a Radically New Approach Under the EU's Medical Device Regulation?

Autoren: Smith HL Price WN 2nd

Quelle: The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics [J Law Med Ethics] 2025; Vol. 53 (3), pp. 465-466. Date of Electronic Publication: 2025 Sep 15.

Publikationsart: Journal Article; Review

Info zur Zeitschrift: Publisher: Cambridge University Press Country of Publication: England NLM ID: 9315583 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1748-720X (Electronic) Linking ISSN: 10731105 NLM ISO Abbreviation: J Law Med Ethics Subsets: MEDLINE

MeSH-Schlagworte: Medical Device Legislation* , Government Regulation* , Equipment and Supplies* , Language*, Humans ; European Union

Harmonization of regulatory frameworks for medical devices in BRICS countries: A path to enhanced trade and investment.

Autoren: Pawar H Patel M

Quelle: Annales pharmaceutiques francaises [Ann Pharm Fr] 2025 Mar; Vol. 83 (2), pp. 272-286. Date of Electronic Publication: 2024 Aug 22.

Publikationsart: Journal Article; Review

Info zur Zeitschrift: Publisher: Elsevier Masson Editeur Country of Publication: France NLM ID: 2985176R Publication Model: Print-Electronic Cited Medium: Internet ISSN: 0003-4509 (Print) Linking ISSN: 00034509 NLM ISO Abbreviation: Ann Pharm Fr Subsets: MEDLINE

MeSH-Schlagworte: Equipment and Supplies*/economics , Equipment and Supplies*/standards , Medical Device Legislation*, Humans ; India ; Commerce ; Russia ; Brazil ; South Africa ; China ; Investments ; Device Approval/legislation & jurisprudence

Regulatory approaches towards AI Medical Devices: A comparative study of the United States, the European Union and China.

Autoren: Tang D Xi X Li Y et al.

Quelle: Health policy (Amsterdam, Netherlands) [Health Policy] 2025 Mar; Vol. 153, pp. 105260. Date of Electronic Publication: 2025 Feb 01.

Publikationsart: Journal Article; Comparative Study; Review

Info zur Zeitschrift: Publisher: Elsevier Scientific Publishers Country of Publication: Ireland NLM ID: 8409431 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1872-6054 (Electronic) Linking ISSN: 01688510 NLM ISO Abbreviation: Health Policy Subsets: MEDLINE

MeSH-Schlagworte: Artificial Intelligence*/legislation & jurisprudence , Equipment and Supplies*/standards , Government Regulation* , Medical Device Legislation*, China ; European Union ; United States ; Humans ; Device Approval/legislation & jurisprudence

Ensuring Medical Device Safety: The Role of Standards Organizations and Regulatory Bodies.

Autoren: Daryanani AE Maduekwe UN Baird P et al.

Quelle: Journal of medical systems [J Med Syst] 2025 Jan 25; Vol. 49 (1), pp. 16. Date of Electronic Publication: 2025 Jan 25.

Publikationsart: Journal Article; Review

Info zur Zeitschrift: Publisher: Kluwer Academic/Plenum Publishers Country of Publication: United States NLM ID: 7806056 Publication Model: Electronic Cited Medium: Internet ISSN: 1573-689X (Electronic) Linking ISSN: 01485598 NLM ISO Abbreviation: J Med Syst Subsets: MEDLINE

MeSH-Schlagworte: Equipment Safety*/standards , Equipment and Supplies*/standards , Patient Safety*/standards , Medical Device Legislation* , Device Approval*/legislation & jurisprudence, Humans ; United States ; United States Food and Drug Administration

A Machine Learning Algorithm to Predict Medical Device Recall by the Food and Drug Administration.

Autoren: Barbosa Slivinskis V Agi Maluli I Seth Broder J

Quelle: The western journal of emergency medicine [West J Emerg Med] 2025 Jan; Vol. 26 (1), pp. 161-170.

Publikationsart: Journal Article

Info zur Zeitschrift: Publisher: Department of Emergency Medicine, University of California, Irvine Country of Publication: United States NLM ID: 101476450 Publication Model: Print Cited Medium: Internet ISSN: 1936-9018 (Electronic) Linking ISSN: 1936900X NLM ISO Abbreviation: West J Emerg Med Subsets: MEDLINE

MeSH-Schlagworte: United States Food and Drug Administration* , Machine Learning* , Algorithms* , Medical Device Recalls*, United States ; Humans ; Sensitivity and Specificity

Orphan and paediatric medical devices in Europe: recommendations to support their availability for on-label and off-label clinical indications.

Autoren: Melvin T Dooms MM Koletzko B et al.

Quelle: Expert review of medical devices [Expert Rev Med Devices] 2024 Oct; Vol. 21 (10), pp. 893-901. Date of Electronic Publication: 2024 Sep 20.

Publikationsart: Journal Article; Review

Info zur Zeitschrift: Publisher: Taylor & Francis Country of Publication: England NLM ID: 101230445 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1745-2422 (Electronic) Linking ISSN: 17434440 NLM ISO Abbreviation: Expert Rev Med Devices Subsets: MEDLINE

MeSH-Schlagworte: Device Approval*/legislation & jurisprudence , Equipment and Supplies*/economics , Medical Device Legislation*, Child ; Humans ; Europe ; Off-Label Use/legislation & jurisprudence ; Pediatrics/instrumentation ; Rare Diseases/therapy

The 510(k) Ancestry of Transvaginal Mesh: When the Subject Is Not a Predicate.

Autoren: Rosh J Bell CM Urbach DR

Quelle: JAMA surgery [JAMA Surg] 2021 Aug 01; Vol. 156 (8), pp. 701-702.

Publikationsart: Historical Article; Journal Article

Info zur Zeitschrift: Publisher: American Medical Association Country of Publication: United States NLM ID: 101589553 Publication Model: Print Cited Medium: Internet ISSN: 2168-6262 (Electronic) Linking ISSN: 21686254 NLM ISO Abbreviation: JAMA Surg Subsets: MEDLINE

MeSH-Schlagworte: Medical Device Legislation*, Device Approval/*legislation & jurisprudence , Prostheses and Implants/*history , Surgical Mesh/*history, Female ; History, 20th Century ; History, 21st Century ; Humans ; Medical Device Recalls ; Pelvic Organ Prolapse/surgery ; Product Surveillance, Postmarketing ; Prostheses and Implants/adverse effects ; Surgical Mesh/adverse effects ; Urinary Incontinence, Stress/surgery