Software programmes employed as medical devices
Abstract
The opportunity to successfully develop and roll out patient-centric digital health platforms is represented by Software as a medical device (SaMD).Software is now a crucial component of all products and is widely integrated into digital platforms that are used for medical purposes as technology in all areas of health care continues to progress. Artificial intelligence (AI) is a potent and currently evolving technology that has the potential to enhance capabilities in a wide range of sectors. Medical device companies have been fascinated in artificial intelligence. Nowadays Artificial intelligence based medical devices are gaining a lot of attention. Artificial intelligence-enabled medical devices have the potential to completely transform the way that healthcare is provided by enabling physicians to diagnose and treat their patients more precisely and successfully while also enhancing their overall level of care. The three primary objectives of the medical devices that are incorporated with AI are being developed by medical device companies as technology progresses are chronic disease management, medical imaging and Internet of Things (IoT). Quite apart from its advantages, artificial intelligence in medical devices also has drawbacks, such as the necessity for regulation to keep up with the rate of technological innovation. The softwares such as Eye Art and IDxDR for the identification of diabetic retinopathy, Quant X for breast abnormalities, Gleamer BoneView for fractures on X rays and software for the management of type 1 diabetes i.e., Dreamed Advisor Pro and as well as the AI-ECG platform are just a few instances of the artificial intelligence-infused software’s that are discussed in this article.
Keywords:
Digital health, Artificial intelligence, Diabetic retinopathy, Breast abnormalities, Fractures on X rays, Type 1 diabetes, AI-ECG platform
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References
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9.Viatom.Solve remote ECG diagnosis in primary and central hospitals with AI-based technology,https://www.viatomtech.com/ai-ecg-platform#:~:text=AI%2DECG%20cloud%20service,dynamic%20and%20static%20ECG%2C%20etc.
&text=AI%2DECG%20Platform%20is%20available,centers%EF%BC%8Cas%20well%20as%20individual.
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report-in-real-time-696653(accessed 2022).
12.Malavika Bhaskaranand, Chaithanya Ramachandra, Sandeep Bhat, et al.The Value of Automated Diabetic Retinopathy Screening with the EyeArt System: A Study of More Than 100,000 Consecutive Encounters from People with Diabetes. Diabetes Technology and Therapeutics 2019;21(11): 635–643.
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24.Rajiv Singla, Ankush Singla, Yashdeep Gupta, et al. Artificial Intelligence/Machine Learning in Diabetes Care. Indian Journal of Endocrinology and Metabolism2019;23(4):495-497.
25.Business Wire. DreaMed Receives FDA Clearance for its Type 2 Diabetes AI-based Clinical DecisionSupport System,https://www.businesswire.com/news/home/20211006005640/en/DreaMed-Receives-FDA-Clearance-for-its-Type-2-Diabetes-AI-based-Clinical-Decision-Support-System(accessed 6 October 2021).
26.Juan Li, Jin Huang,Lanbo Zheng, et al.Application of Artificial Intelligence in Diabetes Education and Management: Present Status and Promising Prospect. Frontiers in Public Health 2020;8: 173.
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29.Applied Radiology.AI A Promising Tool for Breast Cancer Detection,https://www.appliedradiology.com/communities/Artificial-Intelligence/ai-a-promising-tool-for-breast-cancer-detection(accessed 30 March 2022).
30.Masud, R., Al-Rei, M. and Lokker, C. Computer-aided detection for breast cancer screening in clinical settings: Scoping review. JMIR Medical Informatics2019;7(3): 1-14.
31.U.S. Food & Drug Administration. DEN 170022 Summary,https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170022.pdf
32.Cision.QuantX Artificial Intelligence (AI) Breast Cancer Diagnosis System Receives 2020 Gold Edison Award,https://www.prnewswire.com/news-releases/quantx-artificial-intelligence-ai-breast-cancer-diagnosis-system-receives-2020-gold-edison-award-301027112 (accessed 19 March 2020).
33.Forefront.Artificial intelligence software for breast cancer diagnosis makes TIME's list of Best Inventions for 2019,https://www.uchicagomedicine.org/forefront/cancer-articles/artificial-intelligence-software-for-breast-cancer-diagnosis-time-best-inventions-2019#:~:text=QuantX%20%E2%80%94%20the%20first%2Dever%2C,can%20lead%20to%20unnecessary%20biopsies (accessed 3 December 2019).
34.Rachel Y L Kuo ,Conrad Harrison ,Terry-Ann Curran, et al. Artificial Intelligence in Fracture Detection: A Systematic Review and Meta-Analysis. Radiology2022;304(1):50-62.
35.NS Medical Devices. Gleamer’s BoneView AI software gets FDA clearance,https://www.nsmedicaldevices.com/news/gleamer-boneview-ai-software-fda/ (accessed 4 March 2022).
36.Cision.GLEAMER Receives FDA Clearance for Its Artificial Intelligence Software to Help Detect and Localize Fractures,https://www.prnewswire.com/news-releases/gleamer-receives-fda-clearance-for-its-artificial-intelligence-software-to-help-detect-and-localize-fractures-301493376.html(accessed 2 March 2022).
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38.Gleamer.AI application sees fractures on X-rays,https://www.gleamer.ai/news/ai-application-sees-fractures-on-x-rays/ (accessed 9 June 2021).
39.AI for radiology. BoneView,https://grand-challenge.org/aiforradiology/product/gleamer-ai-boneview/ (accessed 19 October 2022)
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41.Guermazi A, Tannoury C, kompel AJ, et al. Improving Radiographic Fracture Recognition Performance and Efficiency Using Artificial Intelligence. Radiology 2022;302(3):627-636.
2.U.S. Food & Drug Administration.Artificial Intelligence and Machine Learning in Software as a Medical Device,https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device(accessed 22 September 2021).
3.Sterling Medical Devices.The Use of Artificial Intelligence in Medical Devices,https://sterlingmedicaldevices.com/the-use-of-artificial-intelligence-in-medical-devices(accessed 20 December 2021).
4.U.S. Food & Drug Administration. Software as a Medical Device,https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd (accessed 4 December 2018).
5.European Commission.Artificial Intelligence-based software as a medical device,https://ati.ec.europa.eu/reports/product-watch/artificial-intelligence-based-software-medical-device(accessed July 2020).
6.Liam Butler, Oguz Akbilgic, Ibrahim Karabayir, et al.ECG-AI: electrocardiographic artificial intelligence model for prediction of heart failure. European Heart Journal - Digital Health2021;2(4): 626–634.
7.AI-ECG Platform. https://www.carewell.com.cn/en/AI-ECG.html.
8.Konstantinos C. Siontis, Peter A. Noseworthy, Zachi I. Attia, et al. Artificial intelligence-enhanced electrocardiography in cardiovascular disease management. Nature Reviews Cardiology 2021;18:465–478.
9.Viatom.Solve remote ECG diagnosis in primary and central hospitals with AI-based technology,https://www.viatomtech.com/ai-ecg-platform#:~:text=AI%2DECG%20cloud%20service,dynamic%20and%20static%20ECG%2C%20etc.
&text=AI%2DECG%20Platform%20is%20available,centers%EF%BC%8Cas%20well%20as%20individual.
10.U.S. Food & Drug Administration. Traditional 510(k) Premarket Notification,https://www.accessdata.fda.gov/cdrh_docs/pdf18/K180432.pdf(accessed 2018).
11.Jerusalem post.AI Enters medical industry- AI-ECG platform diagnoses ECG report in real time,https://www.jpost.com/special-content/ai-enters-medical-industry-ai-ecg-platform-diagnoses-ecg-
report-in-real-time-696653(accessed 2022).
12.Malavika Bhaskaranand, Chaithanya Ramachandra, Sandeep Bhat, et al.The Value of Automated Diabetic Retinopathy Screening with the EyeArt System: A Study of More Than 100,000 Consecutive Encounters from People with Diabetes. Diabetes Technology and Therapeutics 2019;21(11): 635–643.
13.Review of Ophthalmology. EyeArt AI Screening System for DR,https://www.reviewofophthalmology.com/article/eyeart-ai-screening-system-for-dr (accessed 6 October 2020).
14.Review of Ophthalmology. Ophthalmologists in the Machine: The AI Era,https://www.reviewofophthalmology.com/article/ophthalmologists-in-the-machine-the-ai-era (accessed 5 November 2020).
15.Eyenuk. EyeArt® AI Eye Screening System,https://eyenuk.com/en/products/eyeart/
16.U.S. Food & Drug Administration. EyeArt 510(k) Summary (K200667),https://www.accessdata.fda.gov/cdrh_docs/pdf20/K200667.pdf
17.Srikanta Kumar Padhy, Brijesh Takkar, Rohan Chawla, et al. Artificial intelligence in diabetic retinopathy: A natural step to the future. Indian journal of ophthalmology 2019;67(7):1004-1009.
18.Medical Device Network.FDA clears AI-based device for diabetic eye disease detection,https://www.medicaldevice-network.com/news/fda-clears-ai-based-device-diabetic-eye-disease-detection/ (accessed 12 April 2018).
19.NS Medical Devices .The cloud-based tech that uses AI in medical diagnosis for adults with diabetes,https://www.nsmedicaldevices.com/analysis/idx-dr-artificial-intelligence-medical-diagnosis/ (accessed 29 January 2019).
20.The Verge.AI Software that helps doctors diagnose like specialists is approved by FDA,https://www.theverge.com/2018/4/11/17224984/artificial-intelligence-idxdr-fda-eye-disease-diabetic-rethinopathy (accessed 11April 2018).
21.U.S. Food & Drug Administration. De Novo Summary (DEN180001),https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180001.pdf
22.DigitalDiagnostics.IDx-DR,https://www.digitaldiagnostics.com/products/eye-disease/idxdr/#:~:text=How%20does%20IDx%2DDR%20work,(including%20diabetic%20macular%20edema)
23.Nvidia.Vision of AI: Start-up Helps Diabetic Retinopathy Patients Retain Their Sight, https://blogs.nvidia.com/blog/2020/09/11/digital-diagnostics-idx-dr/ (accessed 11September 2020).
24.Rajiv Singla, Ankush Singla, Yashdeep Gupta, et al. Artificial Intelligence/Machine Learning in Diabetes Care. Indian Journal of Endocrinology and Metabolism2019;23(4):495-497.
25.Business Wire. DreaMed Receives FDA Clearance for its Type 2 Diabetes AI-based Clinical DecisionSupport System,https://www.businesswire.com/news/home/20211006005640/en/DreaMed-Receives-FDA-Clearance-for-its-Type-2-Diabetes-AI-based-Clinical-Decision-Support-System(accessed 6 October 2021).
26.Juan Li, Jin Huang,Lanbo Zheng, et al.Application of Artificial Intelligence in Diabetes Education and Management: Present Status and Promising Prospect. Frontiers in Public Health 2020;8: 173.
27.Advisor Pro.Advisor Pro,https://dreamed-diabetes.com/advisor/(accessed2022)
28.U.S. Food & Drug Administration. den 170043 Summary,https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170043.pdf
29.Applied Radiology.AI A Promising Tool for Breast Cancer Detection,https://www.appliedradiology.com/communities/Artificial-Intelligence/ai-a-promising-tool-for-breast-cancer-detection(accessed 30 March 2022).
30.Masud, R., Al-Rei, M. and Lokker, C. Computer-aided detection for breast cancer screening in clinical settings: Scoping review. JMIR Medical Informatics2019;7(3): 1-14.
31.U.S. Food & Drug Administration. DEN 170022 Summary,https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170022.pdf
32.Cision.QuantX Artificial Intelligence (AI) Breast Cancer Diagnosis System Receives 2020 Gold Edison Award,https://www.prnewswire.com/news-releases/quantx-artificial-intelligence-ai-breast-cancer-diagnosis-system-receives-2020-gold-edison-award-301027112 (accessed 19 March 2020).
33.Forefront.Artificial intelligence software for breast cancer diagnosis makes TIME's list of Best Inventions for 2019,https://www.uchicagomedicine.org/forefront/cancer-articles/artificial-intelligence-software-for-breast-cancer-diagnosis-time-best-inventions-2019#:~:text=QuantX%20%E2%80%94%20the%20first%2Dever%2C,can%20lead%20to%20unnecessary%20biopsies (accessed 3 December 2019).
34.Rachel Y L Kuo ,Conrad Harrison ,Terry-Ann Curran, et al. Artificial Intelligence in Fracture Detection: A Systematic Review and Meta-Analysis. Radiology2022;304(1):50-62.
35.NS Medical Devices. Gleamer’s BoneView AI software gets FDA clearance,https://www.nsmedicaldevices.com/news/gleamer-boneview-ai-software-fda/ (accessed 4 March 2022).
36.Cision.GLEAMER Receives FDA Clearance for Its Artificial Intelligence Software to Help Detect and Localize Fractures,https://www.prnewswire.com/news-releases/gleamer-receives-fda-clearance-for-its-artificial-intelligence-software-to-help-detect-and-localize-fractures-301493376.html(accessed 2 March 2022).
37.Healthcare.AI software to help identify bone trauma at the point of care,https://healthcare-in-europe.com/en/news/fujifilm-ai-software-bone-trauma-point-of-care.html (accessed 19 July 2022).
38.Gleamer.AI application sees fractures on X-rays,https://www.gleamer.ai/news/ai-application-sees-fractures-on-x-rays/ (accessed 9 June 2021).
39.AI for radiology. BoneView,https://grand-challenge.org/aiforradiology/product/gleamer-ai-boneview/ (accessed 19 October 2022)
40.Duron L, Ducarouge A, Gillibert A, et al. Assessment of an AI Aid in Detection of Adult Appendicular Skeletal Fractures by Emergency Physicians and Radiologists: A Multicentre Cross-sectional Diagnostic Study. Radiology2021;300(1):120-129.
41.Guermazi A, Tannoury C, kompel AJ, et al. Improving Radiographic Fracture Recognition Performance and Efficiency Using Artificial Intelligence. Radiology 2022;302(3):627-636.
Published
16-06-2023
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Suravarapu ST, Yetukuri K. Software programmes employed as medical devices. World Journal of Current Med and Pharm Research [Internet]. 2023Jun.16 [cited 2025May18];5(3):67-4. Available from: https://wjcmpr.com/index.php/journal/article/view/268
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