Forest Devices received FDA 510(k) clearance for its SignalNED Model RE system for brain state analysis. This marks the first FDA clearance for the company, which won MedTech Innovator’s 2019 accelerator competition. Forest Devices, founded in 2015, develops technology for aiding in stroke detection.
Related: Penumbra secures CE mark for CAVT technologies in Europe
SignalNED leverages EEG technology to analyze a patient’s brain to provide relevant information about their neurologic state (qEEG). The system utilizes a novel, rapidly deployed EEG headset, called the Sensor Cap, along with a portable device.
The Sensor Cap enables quick application by giving the user direct connection feedback at each electrode site. Forest Devices’ device and headset work together as a system with easy-to-use hardware. It allows users to apply the device and run the test in 5-7 minutes. Once finished with the test, SignalNED provides a clear result, delivering critical insight into a patient’s brain state.
“This notable accomplishment marks a key advancement for Forest,” Laura Lyons, CEO of Forest Devices, said. “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.”
