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Zeto announces FDA 510(k) clearance of Zeto New Wave™, advancing efficiency in outpatient EEG

DateApril 2, 2026
CategoriesCohort News
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RALEIGH, N.C., April 2, 2026 – Zeto, Inc., a medical technology company dedicated to making brain health insights through EEG a foundational vital sign in healthcare, announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Zeto New Wave™, its newest EEG system for outpatient clinics and homes.

Zeto New Wave™ offers an easy-to-use outpatient EEG solution with full head coverage. Available in adult and pediatric sizes.

Patients across the U.S. often wait weeks for an EEG appointment, delaying critical answers and care. Clinics are also under pressure, facing shortages of specialized EEG technologists and relying on traditional setups that can be slow and cumbersome. Together, these challenges can significantly delay both patient testing and related follow-up care.

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