Abstract Medical devices play a crucial role in modern healthcare, providing innovative solutions for diagnosing, preventing, monitoring, and treating ailments. Artificial Intelligence is transforming the field of medical devices, offering unprecedented opportunities through diagnostic accuracy, personalized treatment plans, and enhancing patient outcomes. This review outlines the applications of artificial intelligence-based medical devices in healthcare specialties, especially in dentistry, medical imaging, ophthalmology, mental health, autism spectrum disorder diagnosis, oncology, and general medicine. Specifically, the review highlights advancements such as improved diagnostic accuracy, tailored treatment planning, and enhanced clinical outcomes in the above-mentioned applications. Regulatory approval remains a key issue, where medical devices must be approved or cleared by the United States Food and Drug Administration to establish their safety and efficacy. The regulatory guidance pathway for artificial intelligence-based medical devices is presented and moreover the critical technical, ethical, and implementation challenges that must be addressed for large-scale adoption are discussed. The review concludes that the intersection of artificial intelligence with the medical device domain and internet-enabled or enhanced technology, such as biotechnology, nanotechnology, and personalized therapeutics, enables an enormous opportunity to accelerate customized and patient-centered care. By evaluating these advancements and challenges, the study aims to present insights into the future trajectory of smart medical technologies and their role in advancing personalized, patient-centered care. 
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                            Thinking Beyond the Device: An Overview of Human- and Equity-Centered Approaches for Health Technology Design
                        
                    
    
            A shift in the traditional technocentric view of medical device design to a human-centered one is needed to bridge existing translational gaps and improve health equity. To ensure the successful and equitable adoption of health technology innovations, engineers must think beyond the device and the direct end user and must seek a more holistic understanding of broader stakeholder needs and the intended context of use early in a design process. The objectives of this review article are ( a) to provide rationale for the need to incorporate meaningful stakeholder analysis and contextual investigation in health technology development and biomedical engineering pedagogy, ( b) to review existing frameworks and human- and equity-centered approaches to stakeholder engagement and contextual investigation for improved adoption of innovative technologies, and ( c) to present case studyexamples of medical device design that apply these approaches to bridge the gaps between biomedical engineers and the contexts for which they are designing. 
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                            - Award ID(s):
- 2201981
- PAR ID:
- 10499380
- Publisher / Repository:
- Annual Review of Biomedical Engineering
- Date Published:
- Journal Name:
- Annual Review of Biomedical Engineering
- Volume:
- 25
- Issue:
- 1
- ISSN:
- 1523-9829
- Page Range / eLocation ID:
- 257 to 280
- Format(s):
- Medium: X
- Sponsoring Org:
- National Science Foundation
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