TBI Action Alliance

?? New Regulatory Milestone for Beacon Biosignals! ?? We're excited to announce that the FDA has authorized the Dreem 3S system as the first sleep wearable with a Predetermined Change Control Plan (PCCP)! This authorization allows Beacon to update the Dreem 3S sleep staging algorithm without the need for a new 510(k) submission, streamlining the process for enhancing the device’s capabilities and advancing its medical technology. The Dreem 3S originally received FDA 510(k) clearance in August 2023, and has already has already transformed sleep monitoring with its in-home EEG capabilities, offering a clinically validated alternative to in-lab polysomnography for assessing sleep architecture. This PCCP authorization enables Beacon to further refine the machine learning algorithms powering Dreem 3S, ensuring that updates meet rigorous safety and efficacy standards while keeping pace with advancements in machine learning and neurotechnology. Earlier this year, Beacon received the FDA’s first PCCP authorization for a sleep-related medical device with its SleepStageML? AI software, which can automatically score and analyze signals acquired from any EEG or polysomnograph. “With the PCCP in place, we can rapidly integrate new advancements in machine learning into Dreem 3S, ensuring even greater accuracy and reliability in sleep staging," said Alexander Chan, PhD, VP of Analytics and Machine Learning at Beacon Biosignals. "This capability will deepen insights into sleep disorders and strengthen our ability to support therapy development in neurology, psychiatry, and beyond.” The PCCP for both our Dreem 3S hardware and our SleepStageML algorithm ensures the ongoing enhancement of our capabilities to help our biopharma partners evaluate sleep dysfunction in neuropsychiatric diseases. Together, we can continue to help uncover novel therapeutic approaches and meaningful endpoints in clinical trials. Read the full press release: ?? https://lnkd.in/gQhsreE9 Reach out to learn how you can bring sleep endpoints to your trials: ?? https://lnkd.in/errYwFaE #PCCP #FDAclearance #Dreem #sleep #biosignals #EEG #PSG #Beacon

ONLINE today = COSMOPOLITAN Magazine raises awareness of brain injury to a new generation of young women featuring @AshtonKroner, Daneen Brooks, Freya, Dr. Nathan Zasler and me. Please share! https://lnkd.in/eDyFZnyA Thank you to Cosmo Lifestyle Editor, Hannah Chubb, or researching this topic, interviewing us with such care and respect, and writing this article. #Cosmopolitan #brainjury #concussion #pinkTBI

In a victory for the brain injury community, the Centers for Medicare and Medicaid Services (CMS) has added traumatic brain injury (TBI) to its list of chronic health conditions. This is an important first step in our fight to expand coverage for brain injury beyond acute care and helps us to make our case that brain injury should be treated by healthcare providers as a chronic condition like heart disease or diabetes. Read more about what’s next here: https://bit.ly/3Wz0nnI

As we observe Mental Health Awareness Month this May, it's essential to highlight the interconnection between mental health and traumatic brain injuries (TBIs), especially among our military populations. TBIs are a major cause of death and disability in the United States, significantly impacting health outcomes and quality of life. In 2020, there were?more than 214,000 TBI-related hospitalizations, and every day in 2021, approximately 190 Americans died from TBI-related injuries. The mental health repercussions of TBIs are significant, with increased risks of mood disorders and other psychological impacts. Studies indicate that individuals with TBIs are?more likely to suffer from anxiety disorders compared to those without. Addressing these issues requires a comprehensive approach that includes prevention, prompt diagnosis, effective treatment, and ongoing support. ? This Mental Health Awareness Month, let's commit to improving our understanding and support for those affected by TBIs, enhancing both prevention and care to foster better health outcomes. Together, we can make a significant difference in the lives of those impacted by TBIs and associated mental health challenges. #MentalHealthAwarenessMonth