Pittsburgh, PA, September 18, 2024 — Forest Devices Inc. announces receiving FDA 510(k) clearance for the SignalNED Model RE System. The company’s first clearance is an essential step in the growth of the SignalNED platform, leveraging EEG technology to analyze a patient’s brain to provide clinicians with relevant information about their neurologic state (qEEG). Laura Lyons, CEO of Forest Devices, comments, “This notable accomplishment marks a key advancement for Forest. 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.”
FOR IMMEDIATE RELEASE:
Forest Devices Inc. Receives FDA 510(k) Clearance for
the SignalNED Model RE System
The SignalNED Model RE System utilizes a novel, rapidly deployed EEG headset (the Sensor Cap) along with a portable device to rapidly acquire EEG from a patient. The Sensor Cap enables quick application by giving the user direct connection feedback at each electrode site. The device and headset work together as a system, featuring easy-to-use hardware and allowing users to apply the device and run the test in five to seven minutes. Once the test is done, SignalNED provides a clear result, providing critical insight into a patient's brain state.
Dan Willis, CTO of Forest, commented: “This milestone represents a significant achievement for our entire team and a testament to the dedication and collaboration that brought us here. We are eager to continue to advance the SignalNED platform and remain focused on helping those at risk of stroke.”
Forest Devices, Inc. is a Pittsburgh-based medical device company founded in 2015. The company is focused on developing the SignalNED Platform, a collection of technologies to transform early stroke detection. Forest Devices strives to reduce stroke-related death and disability that affects over 15 million worldwide per year.