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Tue. Mar 10, 2026

Wed. Mar 11, 2026

Thu. Mar 12, 2026

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Digital biomarkers and approval review of medical devices

Recently, wearable devices such as smartwatches have allowed us to monitor and record a variety of activities and signals in humans over time. By analyzing such quantitative and objective measurements called "digital biomarkers," there is a growing trend to not only visualize health conditions in daily life and the effects of various interventions on disease treatment, but also to realize early diagnosis and prediction of diseases. In this background, different industries including pharmaceutical companies intend to utilize digital biomarkers in order to advance medical care and healthcare. Nevertheless, relevance of these parameters to physiological and pathological significance have not yet been fully understood; this standpoint requires physiologists to play essential roles. The symposium invites leading experts from industry, government, and academia who are actively working on digital biomarkers to share the current status of their utilization and discuss the prospects.

【J】Utilization and application of "digital biomarker": status quo and prospects

The 103rd Annual Meeting of The Physiological Society of Japan

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[1S01m-05]Digital biomarkers and approval review of medical devices

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