191 related articles for article (PubMed ID: 37405771)
1. Marketing and US Food and Drug Administration Clearance of Artificial Intelligence and Machine Learning Enabled Software in and as Medical Devices: A Systematic Review.
Clark P; Kim J; Aphinyanaphongs Y
JAMA Netw Open; 2023 Jul; 6(7):e2321792. PubMed ID: 37405771
[TBL] [Abstract][Full Text] [Related]
2. The 2021 landscape of FDA-approved artificial intelligence/machine learning-enabled medical devices: An analysis of the characteristics and intended use.
Zhu S; Gilbert M; Chetty I; Siddiqui F
Int J Med Inform; 2022 Sep; 165():104828. PubMed ID: 35780651
[TBL] [Abstract][Full Text] [Related]
3. FDA-cleared artificial intelligence and machine learning-based medical devices and their 510(k) predicate networks.
Muehlematter UJ; Bluethgen C; Vokinger KN
Lancet Digit Health; 2023 Sep; 5(9):e618-e626. PubMed ID: 37625896
[TBL] [Abstract][Full Text] [Related]
4. Approval of artificial intelligence and machine learning-based medical devices in the USA and Europe (2015-20): a comparative analysis.
Muehlematter UJ; Daniore P; Vokinger KN
Lancet Digit Health; 2021 Mar; 3(3):e195-e203. PubMed ID: 33478929
[TBL] [Abstract][Full Text] [Related]
5. Trends in clinical validation and usage of US Food and Drug Administration-cleared artificial intelligence algorithms for medical imaging.
Khunte M; Chae A; Wang R; Jain R; Sun Y; Sollee JR; Jiao Z; Bai HX
Clin Radiol; 2023 Feb; 78(2):123-129. PubMed ID: 36625218
[TBL] [Abstract][Full Text] [Related]
6. Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017.
Dubin JR; Simon SD; Norrell K; Perera J; Gowen J; Cil A
JAMA Netw Open; 2021 May; 4(5):e217274. PubMed ID: 33956132
[TBL] [Abstract][Full Text] [Related]
7. Artificial Intelligence in Breast Cancer Screening: Evaluation of FDA Device Regulation and Future Recommendations.
Potnis KC; Ross JS; Aneja S; Gross CP; Richman IB
JAMA Intern Med; 2022 Dec; 182(12):1306-1312. PubMed ID: 36342705
[TBL] [Abstract][Full Text] [Related]
8. Discrepancies Between Clearance Summaries and Marketing Materials of Software-Enabled Medical Devices Cleared by the US Food and Drug Administration.
Shah NH; Mello MM
JAMA Netw Open; 2023 Jul; 6(7):e2321753. PubMed ID: 37405777
[No Abstract] [Full Text] [Related]
9. FDA-approved machine learning algorithms in neuroradiology: A systematic review of the current evidence for approval.
Yearley AG; Goedmakers CMW; Panahi A; Doucette J; Rana A; Ranganathan K; Smith TR
Artif Intell Med; 2023 Sep; 143():102607. PubMed ID: 37673576
[TBL] [Abstract][Full Text] [Related]
10. The regulatory environment for artificial intelligence-enabled devices in the United States.
Liang NL; Chung TK; Vorp DA
Semin Vasc Surg; 2023 Sep; 36(3):435-439. PubMed ID: 37863617
[TBL] [Abstract][Full Text] [Related]
11. The 510(k) Third Party Review Program: Promise and Potential.
Miller BJ; Blanks W; Yagi B
J Med Syst; 2023 Aug; 47(1):93. PubMed ID: 37642768
[TBL] [Abstract][Full Text] [Related]
12. Mature artificial intelligence- and machine learning-enabled medical tools impacting vascular surgical care: A scoping review of late-stage, US Food and Drug Administration-approved or cleared technologies relevant to vascular surgeons.
Stonko DP; Hicks CW
Semin Vasc Surg; 2023 Sep; 36(3):460-470. PubMed ID: 37863621
[TBL] [Abstract][Full Text] [Related]
13. Industry ties and evidence in public comments on the FDA framework for modifications to artificial intelligence/machine learning-based medical devices: a cross sectional study.
Smith JA; Abhari RE; Hussain Z; Heneghan C; Collins GS; Carr AJ
BMJ Open; 2020 Oct; 10(10):e039969. PubMed ID: 33055121
[TBL] [Abstract][Full Text] [Related]
14. US Food and Drug Administration Approvals of Drugs and Devices Based on Nonrandomized Clinical Trials: A Systematic Review and Meta-analysis.
Razavi M; Glasziou P; Klocksieben FA; Ioannidis JPA; Chalmers I; Djulbegovic B
JAMA Netw Open; 2019 Sep; 2(9):e1911111. PubMed ID: 31509209
[TBL] [Abstract][Full Text] [Related]
15. Conflicting information from the Food and Drug Administration: Missed opportunity to lead standards for safe and effective medical artificial intelligence solutions.
Hernandez-Boussard T; Lundgren MP; Shah N
J Am Med Inform Assoc; 2021 Jun; 28(6):1353-1355. PubMed ID: 33674865
[TBL] [Abstract][Full Text] [Related]
16. The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database.
Benjamens S; Dhunnoo P; Meskó B
NPJ Digit Med; 2020; 3():118. PubMed ID: 32984550
[TBL] [Abstract][Full Text] [Related]
17. An FDA Guide on Indications for Use and Device Reporting of Artificial Intelligence-Enabled Devices: Significance for Pediatric Use.
Nelson BJ; Zeng R; Sammer MBK; Frush DP; Delfino JG
J Am Coll Radiol; 2023 Aug; 20(8):738-741. PubMed ID: 37400046
[TBL] [Abstract][Full Text] [Related]
18. Medical devices: US medical device regulation.
Jarow JP; Baxley JH
Urol Oncol; 2015 Mar; 33(3):128-32. PubMed ID: 25458071
[TBL] [Abstract][Full Text] [Related]
19. Orbital Implants Receiving Food and Drug Administration Premarket Notification.
Corcoran Ruiz KM; Vaishnav YJ; Desautels J; Schaefer JL; Migliori ME; Yilmaz T
Ophthalmic Plast Reconstr Surg; 2022 Sep-Oct 01; 38(5):503-506. PubMed ID: 35699217
[TBL] [Abstract][Full Text] [Related]
20. Systematic analysis of the test design and performance of AI/ML-based medical devices approved for triage/detection/diagnosis in the USA and Japan.
Yuba M; Iwasaki K
Sci Rep; 2022 Oct; 12(1):16874. PubMed ID: 36207474
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]