FDA OKs Forest Devices’ SignalNED EEG for Brain Analysis

Forest Devices has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its SignalNED Model RE system.
 
The SignalNED Model RE system uses a novel, rapidly deployed EEG headset (the Sensor Cap) with a portable device to quickly acquire EEG from a patient. The Sensor Cap gives the user direct connection feedback at each electrode site.
 
The device and headset work together, featuring easy-to-use (according to the company) hardware and letting users apply the device and run the test in five to seven minutes. Once the test is completed, SignalNED offers a clear result for critical insights into a patient’s brain state.
 
“This notable accomplishment marks a key advancement for Forest,” said Forest Devices CEO Laura Lyons. “We plan a limited launch this year as we continue to enhance our platform. Our objective is to offer patients facing acute neurological issues timely, objective, and real-time information from the very start of their interaction with healthcare providers. This has been the result of great work from a strong team, and I want to thank both the Forest Board and Investors for their meaningful contributions that allowed us to reach this accomplishment.”

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READ MORE: Positive Study Results Touted for Forest Devices’ Stroke Detection Technology

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Forest Devices’ mission is to reduce stroke-related death and disability that affects more than 15 million worldwide annually.
 
“This milestone represents a significant achievement for our entire team and a testament to the dedication and collaboration that brought us here,” said Forest Devices chief technology officer Dan Willis. “We are eager to continue to advance the SignalNED platform and remain focused on helping those at risk of stroke.”