FDA Relaxes Oversight as Unvalidated Blood Pressure Wearables Flood Market

References

1. 1.Aguilar, M. (2026). Blood pressure tech floods the market after FDA relaxes wearables oversight. STAT News. https://www.statnews.com/2026/05/28/fda-wellness-guidance-unvetted-blood-pressure-tech-floods-market/
2. 2.Virani, S. S., Alonso, A., Aparicio, H. J., Benjamin, E. J., Bittencourt, M. S., Callaway, C. W., ... & Tsao, C. W. (2021). Heart disease and stroke statistics—2021 update: a report from the American Heart Association. Circulation, 143(8), e254-e743. https://doi.org/10.1161/CIR.0000000000000950
3. 3.Picone, D. S., Schultz, M. G., Otahal, P., Aakhus, S., Al-Jumaily, A. M., Black, J. A., ... & Sharman, J. E. (2018). Accuracy of cuff-measured blood pressure: systematic reviews and meta-analyses. Journal of the American College of Cardiology, 71(5), 572-586. https://doi.org/10.1016/j.jacc.2017.10.024
4. 4.Mukkamala, R., Hahn, J. O., Inan, O. T., Mestha, L. K., Kim, C. S., Töreyin, H., & Kyal, S. (2015). Toward ubiquitous blood pressure monitoring via pulse transit time: theory and practice. IEEE Transactions on Biomedical Engineering, 62(11), 2677-2687. https://doi.org/10.1109/TBME.2015.2441951
5. 5.Whelton, P. K., Carey, R. M., Aronow, W. S., Casey, D. E., Collins, K. J., Dennison Himmelfarb, C., ... & Wright, J. T. (2018). 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults. Hypertension, 71(6), e13-e115. https://doi.org/10.1161/HYP.0000000000000065
6. 6.Chandrasekhar, A., Kim, C. S., Naji, M., Natarajan, K., Hahn, J. O., & Mukkamala, R. (2018). Smartphone-based blood pressure monitoring via the oscillometric finger-pressing method. Science Translational Medicine, 10(431), eaap8674. https://doi.org/10.1126/scitranslmed.aap8674
7. 7.Steinhubl, S. R., Muse, E. D., & Topol, E. J. (2015). The emerging field of mobile health: translating written to reality. Science Translational Medicine, 7(283), 283rv3. https://doi.org/10.1126/scitranslmed.aaa3487
8. 8.Topol, E. J. (2019). High-performance medicine: the convergence of human and artificial intelligence. Nature Medicine, 25(1), 44-56. https://doi.org/10.1038/s41591-018-0300-7