Systematically Assessing the Security Risks of AI/ML-enabled Connected Healthcare Systems: Device List


List of FDA-Approved Devices Studied in the Paper:

  1. CardioLogs ECG Analysis Platform [1]

  2. Oxehealth Vital Signs [2]

  3. GI Genius [3]

  4. SOZO [4]

  5. WellDoc BlueStar [5]

  6. d-Nav System [6]

  7. MBT-CA System [7]

  8. KIDScore D3 [8]

  9. NuVasive Pulse System [9]

  10. ABMD Software [10]

  11. Deep Learning Image Reconstruction [11]

  12. Air Next [12]

  13. One Drop Blood Glucose Monitoring System [13]

  14. OTIS 2.1 and THiA Optical Coherence Tomography System [14]

  15. EarliPoint System [15]

  16. BrainScope TBI [16]

  17. IDx-DR v2.3 [17]

  18. Iris Intelligent Retinal Imaging System [18]

  19. Paige Prostate [19]

  20. Tissue of Origin Test Kit [20]

References

  1. U.S. Food & Drug Administration. CardioLogs ECG Analysis Platform, 2017. URL: https://www. accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170568, Last accessed: Aug 31, 2023.

  2. U.S. Food & Drug Administration. Oxehealth Vital Signs, 2021. URL: https://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200019, Last accessed: Aug 31, 2023.

  3. U.S. Food & Drug Administration. GI Genius, 2021. URL: https://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200055, Last accessed: Aug 31, 2023.

  4. U.S. Food & Drug Administration. SOZO, 2019. URL: https://www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfpmn/pmn.cfm?ID=K190529, Last accessed: Aug 31, 2023.

  5. U.S. Food & Drug Administration. Welldoc Bluestar System, 2019. URL: https://www.accessdata.fda. gov/cdrh_docs/pdf19/K190013.pdf, Last accessed: Aug 31, 2023.

  6. U.S. Food & Drug Administration. d-Nav System, 2019. URL: https://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K181916, Last accessed: Aug 31, 2023.

  7. U.S. Food & Drug Administration. MALDI BIOTYPER CA (MBT-CA) SYSTEM, 2013. URL: https:

    //www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K130831, Last accessed: Aug 31, 2023.

  8. U.S. Food & Drug Administration. KIDScore D3, 2019. URL: https://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfpmn/pmn.cfm?ID=K182798, Last accessed: Aug 31, 2023.

  9. U.S. Food & Drug Administration. NuVasive Pulse System, 2018. URL: https://www.accessdata.fda. gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K180038, Last accessed: Aug 31, 2023.

  10. U.S. Food & Drug Administration. ABMD Software, 2022. URL: https://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213760, Last accessed: Aug 31, 2023.

  11. U.S. Food & Drug Administration. Deep Learning Image Reconstruction, 2022. URL: https://www. accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220961, Last accessed: Aug 31, 2023.

  12. U.S. Food & Drug Administration. Air Next, 2020. URL: https://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfpmn/pmn.cfm?ID=K183089, Last accessed: Aug 31, 2023.

  13. U.S. Food & Drug Administration. One Drop Blood Glucose Monitoring System, 2016. URL: https:

    //www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161834, Last accessed: Aug 31, 2023.

  14. U.S. Food & Drug Administration. OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coher- ence Tomography System, 2021. URL: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/ pmn.cfm?ID=K203578, Last accessed: Aug 31, 2023.

  15. U.S. Food & Drug Administration. EarliPoint System, 2021. URL: https://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213882, Last accessed: Aug 31, 2023.

  16. U.S. Food & Drug Administration. BrainScope TBI, 2019. URL: https://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K190815, Last accessed: Aug 31, 2023.

  17. U.S. Food & Drug Administration. IDx-DR v2.3, 2021. URL: https://www.accessdata.fda.gov/scripts/

    cdrh/cfdocs/cfpmn/pmn.cfm?ID=K213037, Last accessed: Aug 31, 2023.

  18. ‌U.S. Food & Drug Administration. IRIS INTELLIGENT RETINAL IMAGING SYSTEM, 2015.

    URL: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K141922, Last ac- cessed: Aug 31, 2023.

  19. U.S. Food & Drug Administration. Paige Prostate, 2021. URL: https://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN200080, Last accessed: Aug 31, 2023.

  20. U.S. Food & Drug Administration. Tissue Of Origin Test Kit FFPE, 2012. URL: https://www.accessdata. fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K120489, Last accessed: Aug 31, 2023.