Search Results

From embodiment to evidence: The harmful intersection of poor regulation of medical implants and obstructed narratives in embodied experiences of failed metal-on-metal hips.

• Authors : McCormack, Pauline

Subjects: PROSTHETICS; COMPLICATIONS of prosthesis; TOTAL hip replacementUNITED Kingdom

• Source: Health: An Interdisciplinary Journal for the Social Study of Health, Illness & Medicine; Jul2024, Vol. 28 Issue 4, p578-595, 18p

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Learnings from the first AI-enabled skin cancer device for primary care authorized by FDA.

• Authors : Venkatesh, Kaushik P.; Kadakia, Kushal T.; Gilbert, Stephen

Subjects: MEDICAL equipment laws; SKIN tumors; DIFFUSION of innovationsUNITED States. Food & Drug Administration

• Source: NPJ Digital Medicine; 6/15/2024, Vol. 7 Issue 1, p1-4, 4p

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Integrated Devices: A New Regulatory Pathway to Promote Revolutionary Innovation.

• Authors : CHO, TED; GOWDA, VRUSHAB; SCHULZRINNE, HENNING

Subjects: DIGITAL technology; POLICY sciences; DIFFUSION of innovationsUNITED StatesUNITED States. Food & Drug Administration; EUROPEAN Union

• Source: Milbank Quarterly; Jun2024, Vol. 102 Issue 2, p367-382, 16p

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"First do no harm" – Primodos, sodium valproate and surgical mesh.

• Authors : Cumberlege, Baroness Julia; Macleod, Sonia

Subjects: PATIENT safety; PREGNANCY tests; VALPROIC acidUNITED Kingdom

• Source: Medico-Legal Journal; Jun2024, Vol. 92 Issue 2, p72-81, 10p

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Medical device regulation: requirements for occupational therapists in The Netherlands who prescribe and manufacture custom-made devices.

• Authors : de Jong, Iwan J.; Lexis, Monique A. S.; Slegers, Karin

Subjects: MANUFACTURING industry equipment; HUMAN services programs; COMPUTER-aided designNETHERLANDS

• Source: Disability & Rehabilitation: Assistive Technology; May2024, Vol. 19 Issue 4, p1415-1423, 9p

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A trustworthy AI reality-check: the lack of transparency of artificial intelligence products in healthcare.

• Authors : Fehr, Jana; Citro, Brian; Malpani, Rohit

Subjects: ARTIFICIAL intelligence laws; DOCUMENTATION; HEALTH services administrationEUROPE

• Source: Frontiers in Digital Health; 2024, p1-11, 11p

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Legistische Neuerungen.

• Authors : Hollenstein, Von Felix; Pixner, Thomas

Subjects: NURSING laws; MEDICAL equipment laws; MEDICAL lawsAUSTRIA

• Source: Journal für Medizin- und Gesundheitsrecht (JMG); dez2023, Vol. 8 Issue 4, p420-422, 3p

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OGH: Amtshaftung für fehlerhaftes behördliches Handeln gemäß Medizinproduktegesetz.

Subjects: PRODUCT liability; MEDICAL equipment laws; OBEDIENCE (Law)AUSTRIA

• Source: Journal für Medizin- und Gesundheitsrecht (JMG); dez2023, Vol. 8 Issue 4, p357-359, 3p

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The 510(k) Third Party Review Program: Promise and Potential.

• Authors : Miller, Brian J.; Blanks, William; Yagi, Brian

Subjects: MEDICAL equipment standards; HEALTH policy; COMPUTER softwareUNITED States. Food & Drug Administration

• Source: Journal of Medical Systems; 8/29/2023, Vol. 47 Issue 1, p1-10, 10p, 3 Graphs

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Artificial intelligence tools in clinical neuroradiology: essential medico-legal aspects.

• Authors : Hedderich, Dennis M.; Weisstanner, Christian; Van Cauter, Sofie

Subjects: ARTIFICIAL intelligence laws; COMPUTER software; PRIVACYUNITED StatesEUROPEAN Union

• Source: Neuroradiology; Jul2023, Vol. 65 Issue 7, p1091-1099, 9p

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