Natus Medical Receives FDA Clearance for Advanced EEG Diagnostic Tool for Epileptic Patients
On December 3, 2025, Natus Medical Incorporated made a significant announcement regarding its BrainWatch point-of-care EEG solution, which has now received FDA 510(k) clearance for the diagnosis of electrographic status epilepticus. This innovative diagnostic capability is a notable advancement for the company, which is recognized globally as a pioneer in EEG technology. With built-in Persyst analysis software, BrainWatch is designed to facilitate rapid diagnosis and treatment intervention when time is of the essence.
This groundbreaking technology can be operational in under five minutes, making it particularly valuable for acute care settings where timely responses are critical. By streamlining treatment decisions in collaboration with neurology experts, BrainWatch aims to enhance patient care significantly. As hospitals grapple with the challenges of providing efficient neurological emergency responses, this diagnostic advancement is both timely and necessary.
The BrainWatch solution is also designed to improve care access, especially for smaller or rural healthcare facilities that may lack sophisticated EEG capabilities. As highlighted by Natus's Vice President of Global Marketing, Jordan Grace Miller, the introduction of the BrainWatch technology allows these institutions to diagnose and manage neurological emergencies confidently, reducing unnecessary patient transfers. This enhancement in diagnostic access leads to better patient management, diminished anxiety, and ultimately, improved treatment outcomes.
The capabilities of BrainWatch go beyond mere monitoring. It provides clinicians with vital data that aid in making informed treatment decisions, thus ensuring that serious conditions, such as status epilepticus, are swiftly addressed. Miller noted that early adopters of BrainWatch have shared positive feedback, indicating a marked decrease in patient transfers from rural hospitals as they can now meet previously unmet diagnostic needs. This not only improves service delivery but also enhances healthcare outcomes for patients.
BrainWatch's monitoring technology is set to be showcased at the American Epilepsy Society's annual meeting from December 6 to 8 in Atlanta, where attendees can explore its state-of-the-art features. Among these features are rapid brain monitoring capabilities for critical patients and automated notifications sent directly to care teams to expedite interventions. Moreover, BrainWatch is eligible for a New Technology Add-on Payment (NTAP), which ensures that hospitals can receive additional funding for utilizing advanced monitoring techniques. The potential reimbursement of up to $913.90 for eligible Medicare patients emphasizes the importance of this technology within the healthcare reimbursement landscape.
For medical professionals looking to enhance their diagnostic arsenal, the integration of the BrainWatch EEG solution into everyday practice presents an opportunity to elevate care standards. Built with Persyst Development Corporation's FDA-cleared Persyst 15 algorithms, BrainWatch allows reliable seizure detection and assessment, along with a comprehensive platform for remote collaboration with neurologists.
Natus Medical continues to be a trusted source for neurodiagnostic solutions, emphasizing its commitment to improving healthcare delivery. As healthcare providers increasingly rely on technology to enhance patient care, innovations like BrainWatch are set to play a pivotal role in the future of neurodiagnostic practices. For more insights and information on Natus's offerings, healthcare professionals are encouraged to visit their website.
The future looks promising for Neurodiagnostic care; with innovations such as BrainWatch paving the way, there's hope for better outcomes in managing complex neurological conditions.