Natus announces FDA 510(k) clearance for electrographic status epilepticus diagnostic indication in BrainWatch point-of-care EEG solution

MIDDLETON, Wis., Dec. 3, 2025 /PRNewswire/ -- Natus Medical Incorporated announced the electrographic status epilepticus diagnosis capability of its BrainWatch point-of-care EEG solution, featuring integrated Persyst analysis software which has received 510(k) clearance from the U.S. Food and Drug Administration.

The BrainWatch solution now includes electrographic status epilepticus monitoring technology, which is eligible for a New Technology Add-on Payment, or NTAP. BrainWatch will be on display Dec. 6-8 during the American Epilepsy Society annual meeting in Atlanta. Visitors to the Natus booth can learn more about the innovative features of the BrainWatch solution, including its fast-and-precise brain monitoring for critical care patients, and email notifications with critical status updates to care teams for rapid intervention.

“At Natus, our mission has always been clear, to advance neurodiagnostic care through innovation that empowers healthcare professionals to improve patient outcomes,” said Natus Vice President of Global Marketing Jordan Grace Miller. “That mission includes a focus on expanding access to care, and our BrainWatch solution can be transformative for smaller, community or rural hospitals who don’t have access to EEG or larger centers with limited EEG expertise during off hours.”

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