US-based medical device startup Forest Devices has received the US Food and Drug Administration (FDA) 510(k) approval for its SignalNED Model RE System.
The SignalNED Model RE System uses a new, rapidly deployed EEG headset, known as the Sensor Cap, along with a portable device to rapidly acquire EEG from a patient.
The Sensor Cap enables quick application by providing direct connection feedback to the users at each electrode site.
The device and headset work together as a system, which features easy-to-use hardware to allow users to apply the device and run the test in five to seven minutes.
Once the test is complete, SignalNED provides a clear result that enables critical insight into the state of the patient’s brain.
Forest Devices CEO Laura Lyons said: “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.”
Established in 2015 in Pittsburgh, Pennsylvania, Forest Devices is a medical device company focused on developing the SignalNED Platform to transform early stroke detection.
The platform leverages EEG technology to analyse a patient’s brain to provide clinicians with relevant information about their neurologic state.
SignalNED Model RE System is the company’s first device to receive FDA approval.
It requires only five minutes from setup to the end of the test, providing a clear result for users and helping medical professionals rapidly obtain an EEG.
The system also provides connection feedback directly at electrode sites, which is easy to use and understand, according to Forest Devices.
Forest CTO Dan Willis said: “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.”
