FDA Clears Empatica’s EmbraceMini for Sleep Monitoring

Boston, MA — Empatica, a pioneer in digital biomarker development and patient monitoring using wearables and AI, today announced that EmbraceMini has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

EmbraceMini was created to address the growing demand for patient-friendly, trustworthy, and scalable actigraphy solutions in clinical trials, especially where reliable and comfortable sleep monitoring is involved. The FDA clearance establishes EmbraceMini as a medical-grade wearable for remote health monitoring, enabling healthcare professionals and researchers to derive high-quality sleep and circadian rhythm assessments from real-world settings. In addition to sleep-related monitoring, the device supports broader analysis of physical activity, including use in clinical research and care contexts where quantifiable assessment of movement is important.