Wearable biosensors can continuously monitor disease biomarkers, therapeutic drugs and health-related analytes to provide real-time diagnostic insights. The wearable biosensor Aptalyzer integrates hydrogel microneedles and an electrochemical aptamer-based biosensor to assess biomarkers in the skin interstitial fluid.
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Acknowledgements
The authors acknowledge support by the Natural Sciences and Engineering Research Council of Canada (NSERC), salary award from the Canada Research Chairs Program to L.S. and M.P., the Leona M. and Harry B. Helmsley Charitable Trust and Breakthrough T1D. M.G. is the recipient of a salary stipend from the CaRDM Eq NSERC CREATE program.
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M.G., S.C., L.S. and M.P. contributed to the planning, writing and editing of the article. R.A.L. and J.LH.-H. contributed to the overall layout and editing of the manuscript and the creation of the figures.
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L.S. and M.P. are co-founders of Aptec Health, a McMaster University and University of Waterloo startup company that is commercializing the Aptalyzer under the following patent: PCT/CA2025/050680.
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2.4 million people: https://go.nature.com/4iiIKmh
Class II medical device: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-862/subpart-B/section-862.1355
Consensus time in range: https://breakthrought1d.ca/aily-management/time-in-range/
De Novo pathway: https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request
Premarket approval: https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma
US$12.6 billion: https://go.nature.com/4rlA2I0
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Garg, M., Chupil, S., L’Heureux-Hache, J. et al. Integrated hydrogel microneedle aptamer sensor for wearable insulin monitoring. Nat Rev Bioeng (2025). https://doi.org/10.1038/s44222-025-00394-3
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DOI: https://doi.org/10.1038/s44222-025-00394-3