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

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."

With the indication to detect and diagnose electrographic status epilepticus, BrainWatch provides additional information that clinical staff can use to make informed treatment decisions, helping ensure that critical neurological emergencies like status epilepticus are not missed.

"We are excited by the feedback we are getting from hospitals that are early adopters to BrainWatch technology," said Miller. "Hospitals in rural areas are transferring fewer patients because they can better meet demands that were previously unmanageable due to a lack of diagnostic access. Without sacrificing the needs of the patient, they now have an option to assess seizures and keep the patient there with confidence. Clinicians have also been able to improve their decision making on seizure rule-out, avoiding unnecessary medication for treatment."

Natus announced the introduction of the BrainWatch technology in May 2025, offering a solution to vital needs identified by customers desiring a point-of-care solution that would be easy to use and interface with NeuroWorks, the EEG platform trusted by more health systems and small hospitals worldwide. By leveraging the NeuroWorks platform, the BrainWatch solution offers a familiar and comprehensive review experience with remote neurologist collaboration 24/7 from any web browser.

The BrainWatch system can be set up in less than five minutes, allowing quick intervention in acute care environments and streamlining treatment decisions with neurology support to improve patient care. It also offers exclusive on-device software built with integrated FDA-cleared, industry-leading Persyst 15 algorithms for seizure detection, seizure burden, and diagnosis of electrographic status epilepticus. Persyst 15 is owned by Persyst Development Corporation.

The electrographic status epilepticus monitoring technology in BrainWatch may qualify for the NTAP for monitoring of brain electrical activity, computer-aided detection and notification using new technology. The maximum incremental payment a hospital may receive for eligible Medicare patients is $913.90.

ABOUT NATUS 

Natus is trusted by healthcare providers around the globe as the solution source to screen, diagnose, and treat disorders affecting the brain and neural pathways. The best-in-class Natus solutions, including service, field support and education, enable clinicians to advance their standard of care, improving patient outcomes and quality of life. For more information on Natus, please visit natus.com/neuro.

CONTACT INFORMATION:   
Lisa Schuler
Phone: +1 612 528-1332
Email: [email protected]

SOURCE Natus Medical Incorporated