Beacon Biosignals

Sleep deficiency is associated with #AlzheimersDisease (AD) pathogenesis. Researchers Gawon Cho, et al. examined the association of sleep architecture with anatomical features observed in #Alzheimers: (1) atrophy of hippocampus, entorhinal, inferior parietal, parahippocampal, precuneus, and cuneus regions (“AD-vulnerable regions”) and (2) cerebral microbleeds. Their research reveals that individuals with lower proportions of time spent in slow wave sleep and rapid eye movement sleep had smaller volumes in critical brain regions, particularly the inferior parietal region, which is known to undergo early structural changes in Alzheimer’s disease. The results were adjusted for potential confounders including demographic characteristics, smoking history, alcohol use, hypertension, and coronary heart disease. Learn More in the Journal of Clinical Sleep Medicine https://lnkd.in/erKVwyrw Lower slow wave sleep and rapid eye movement sleep are associated with brain atrophy of AD-vulnerable regions - Gawon Cho, Adam Mecca, Orfeu Buxton, Xiao Liu, PhD, Brienne Miner Yale School of Medicine Yale Alzheimer’s Disease Research Unit Penn State University

For CNS drug developers, early and objective biomarkers are essential—both for studying at-risk patients and characterizing disease progression. This need is especially urgent in neurodegenerative research. As we start #ParkinsonsAwarenessMonth, it's a timely reminder to rethink how we develop more effective treatments for patients living with these complex conditions. The below data visualizations demonstrate how Beacon’s machine learning models use EEG data to differentiate individuals with Parkinson’s Disease (PD) and related synucleinopathies (REM Sleep Behavior Disorder, Dementia with Lewy Bodies) from healthy sleepers. Using only EEG features as model inputs, our algorithms 𝗰𝗮𝗻 𝗽𝗿𝗲𝗱𝗶𝗰𝘁 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀 𝘄𝗵𝗼 𝗮𝗿𝗲 𝗹𝗶𝗸𝗲𝗹𝘆 𝘁𝗼 𝗱𝗲𝘃𝗲𝗹𝗼𝗽 𝘀𝘆𝗻𝘂𝗰𝗹𝗲𝗶𝗻𝗼𝗽𝗮𝘁𝗵𝗶𝗲𝘀 𝗺𝗮𝗻𝘆 𝘆𝗲𝗮𝗿𝘀 𝗽𝗿𝗶𝗼𝗿 𝘁𝗼 𝗮 𝗳𝗼𝗿𝗺𝗮𝗹 𝗱𝗶𝗮𝗴𝗻𝗼𝘀𝗶𝘀.  Clinical development teams can use this EEG technology to:  ✅ 𝗗𝗲𝘁𝗲𝗰𝘁 𝗲𝗮𝗿𝗹𝘆, 𝘀𝘂𝗯𝘁𝗹𝗲 𝗰𝗵𝗮𝗻𝗴𝗲𝘀. Before motor symptoms emerge, EEG reveals altered sleep patterns in PD and RBD.  ✅ 𝗖𝗵𝗮𝗿𝗮𝗰𝘁𝗲𝗿𝗶𝘇𝗲 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀. EEG-based models show strong accuracy in distinguishing PD, RBD, and DLB from healthy controls of the same age group, and can be used to stratify patients on the basis of sleep EEG biomarkers  ✅ 𝗦𝗰𝗮𝗹𝗲 𝗱𝗮𝘁𝗮 𝗰𝗼𝗹𝗹𝗲𝗰𝘁𝗶𝗼𝗻. EEG data can be captured at home with new technology like our FDA 510(k)-cleared EEG headband, which matches or exceeds sleep staging performance using traditional PSG and manual evaluation. Beacon Biosignals is proud to play a role in advancing Parkinson’s disease research and supporting the development of life-changing treatments. Are you exploring digital biomarkers in your CNS programs? Let’s talk.    📩  Contact us to learn how we support biopharma partners in early- and late-stage clinical trials: https://lnkd.in/errYwFaE #ParkinsonsDisease #EEG #Neuroscience #Neurodegeneration #DigitalBiomarkers

For CNS drug developers, early and objective biomarkers are essential—both for studying at-risk patients and characterizing disease progression. This need is especially urgent in neurodegenerative research. As we start #ParkinsonsAwarenessMonth, it's a timely reminder to rethink how we develop more effective treatments for patients living with these complex conditions. The below data visualizations demonstrate how Beacon’s machine learning models use EEG data to differentiate individuals with Parkinson’s Disease (PD) and related synucleinopathies (REM Sleep Behavior Disorder, Dementia with Lewy Bodies) from healthy sleepers. Using only EEG features as model inputs, our algorithms 𝗰𝗮𝗻 𝗽𝗿𝗲𝗱𝗶𝗰𝘁 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀 𝘄𝗵𝗼 𝗮𝗿𝗲 𝗹𝗶𝗸𝗲𝗹𝘆 𝘁𝗼 𝗱𝗲𝘃𝗲𝗹𝗼𝗽 𝘀𝘆𝗻𝘂𝗰𝗹𝗲𝗶𝗻𝗼𝗽𝗮𝘁𝗵𝗶𝗲𝘀 𝗺𝗮𝗻𝘆 𝘆𝗲𝗮𝗿𝘀 𝗽𝗿𝗶𝗼𝗿 𝘁𝗼 𝗮 𝗳𝗼𝗿𝗺𝗮𝗹 𝗱𝗶𝗮𝗴𝗻𝗼𝘀𝗶𝘀.  Clinical development teams can use this EEG technology to:  ✅ 𝗗𝗲𝘁𝗲𝗰𝘁 𝗲𝗮𝗿𝗹𝘆, 𝘀𝘂𝗯𝘁𝗹𝗲 𝗰𝗵𝗮𝗻𝗴𝗲𝘀. Before motor symptoms emerge, EEG reveals altered sleep patterns in PD and RBD.  ✅ 𝗖𝗵𝗮𝗿𝗮𝗰𝘁𝗲𝗿𝗶𝘇𝗲 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀. EEG-based models show strong accuracy in distinguishing PD, RBD, and DLB from healthy controls of the same age group, and can be used to stratify patients on the basis of sleep EEG biomarkers  ✅ 𝗦𝗰𝗮𝗹𝗲 𝗱𝗮𝘁𝗮 𝗰𝗼𝗹𝗹𝗲𝗰𝘁𝗶𝗼𝗻. EEG data can be captured at home with new technology like our FDA 510(k)-cleared EEG headband, which matches or exceeds sleep staging performance using traditional PSG and manual evaluation. Beacon Biosignals is proud to play a role in advancing Parkinson’s disease research and supporting the development of life-changing treatments. Are you exploring digital biomarkers in your CNS programs? Let’s talk.    📩  Contact us to learn how we support biopharma partners in early- and late-stage clinical trials: https://lnkd.in/errYwFaE #ParkinsonsDisease #EEG #Neuroscience #Neurodegeneration #DigitalBiomarkers

🧠 Sleep disruption isn't just tied to neurodegeneration — it may actively drive it. A new paper published in Neuron (part of Cell Press) highlights what’s becoming increasingly clear: Changes in sleep architecture — especially in REM and slow-wave sleep — both reflect and influence the progression of neurodegenerative diseases like Alzheimer’s and Parkinson’s. However, traditional sleep measurement methods, such as actigraphy (used in many popular sleep wearables) and patient-reported outcomes, fall short. These approaches can’t accurately capture REM, slow-wave sleep, or other critical sleep stages. That’s why adding EEG-based quantitative sleep endpoints to clinical trials is emerging as a strategy to both better understand and better treat neurodegenerative disorders. When clinical teams can measure brain-based sleep stages, they unlock powerful advantages: 🔬 Early Biomarkers  Disruptions in REM and non-REM sleep often appear before cognitive symptoms. EEG-derived sleep metrics offer a way to detect early disease signals in at-risk populations. 💊 Mechanistic Insight  Many CNS drugs affect neural pathways that regulate sleep. Quantifying their effects on sleep stages can reveal insights into pharmacodynamic effects. 🔄 Disease-Modifying Potential  Restoring healthy sleep may help slow disease progression by improving glymphatic clearance and reducing neural stress — breaking the feedback loop between sleep loss and symptom presentation. 📈 Regulatory & Commercial Differentiation  Sleep improvements are meaningful to both patients and regulatory bodies. Sleep staging provides objective data to support broader labels, real-world value, and market differentiation. ✨ This level of precision is now accessible at scale. Beacon Biosignals uses AI to deliver automated, high-fidelity sleep staging from our FDA-cleared at-home EEG headband without the burden of traditional polysomnography — making brain-based sleep biomarkers feasible to collect across all phases of clinical development. Read the full article here: https://lnkd.in/eN-sMV9h #Neurodegeneration #SleepBiomarkers #CNSDrugDevelopment #EEG #Alzheimers #Parkinsons #ClinicalTrials  

Great insights from Alexander Chan, our VP of Analytics and Machine Learning, on how PCCPs are helping AI/ML-powered medical devices evolve safely and efficiently. Beacon Biosignals is proud to be among the first to secure FDA-authorized PCCPs—for both our clinical sleep staging software and our Dreem 3S EEG headband—enabling continuous improvement without compromising compliance. Read the full piece in MedTech Dive: https://lnkd.in/gnPMt-ih #AI #MedicalDevices #PCCP #SleepTech #CNSDrugDevelopment 

Neuroscience urgently needs precise biomarkers for early detection and effective treatment of neurological disorders, but medical devices often struggle to keep pace with research advancements due to lengthy regulatory processes. What if medical devices could evolve as fast as the technology behind them? An FDA-authorized Predetermined Change Control Plan (PCCP) makes this possible, allowing AI/ML-powered medical devices to improve continuously while staying compliant. By streamlining updates without repeated FDA submissions, PCCPs accelerate innovation, expand clinical applications, and bring life-changing technology to patients faster. 🔹 Second Image: The standard regulatory path—every change requires a full FDA review.  🔹 Third Image: With a PCCP—predefined changes go through verification & validation, then move directly to clearance. For AI-driven neuroscience, this means faster improvements and more impactful insights—without compromising safety. At Beacon Biosignals, we've embraced this approach by securing PCCP authorizations for both our AI software, SleepStageML, and our wearable EEG device, Dreem 3S. These FDA 510(k) clearances enable us to continually enhance our technology, ensuring we deliver cutting-edge solutions in sleep monitoring and neurophysiological analysis. Most importantly, it allows us to better serve our biopharma partners across a range of indication areas at speed, accelerating drug development and clinical research. 🔗 Discover how Dreem 3S became the first FDA-authorized sleep wearable with a PCCP: https://lnkd.in/ghZ-fcMu 🔗 See how SleepStageML earned FDA clearance to advance AI-driven sleep analysis: https://lnkd.in/g_2bWkGG #AI #MachineLearning #MedicalDevices #RegulatoryScience #Neuroscience #Innovation

We're now #hiring for two more key roles on our commercial team at Beacon Biosignals. We are deeply technical across neuroscience and machine learning, motivated by our opportunity to transform clinical development alongside our life science partners, and inspired to help people with psychiatric, neurological, and sleep conditions. We're also growing. A lot. The best-fit candidates will use their scientific, strategic, and commercial experience to execute on our growth goals with speed and precision. These roles will report directly to me, but please apply through our normal recruiting channels or contact our recruiter Jake Fischer. Please forward to anyone who would be interested and a good fit!

𝗜𝗺𝗽𝗿𝗼𝘃𝗶𝗻𝗴 𝗣𝗮𝘁𝗶𝗲𝗻𝘁 𝗘𝘅𝗽𝗲𝗿𝗶𝗲𝗻𝗰𝗲 & 𝗗𝗮𝘁𝗮 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝘄𝗶𝘁𝗵 𝗕𝗲𝗮𝗰𝗼𝗻’𝘀 𝗗𝗿𝗲𝗲𝗺 𝟯𝗦 𝗘𝗘𝗚 𝗛𝗲𝗮𝗱𝗯𝗮𝗻𝗱 Clinical trials depend on high-quality, reliable data—but when it comes to sleep studies, traditional in-lab polysomnography (PSG) presents significant challenges. PSG is burdensome for patients, leading to poor usability scores and potential disruptions in natural sleep patterns. 📊 New data confirms that patients overwhelmingly prefer Beacon's Dreem 3S headband over PSG in clinical trials, as shown in System Usability Scale (SUS) scores (first image). The Dreem 3S provides PSG-equivalent data in an at-home, consumer-grade device designed for patient comfort. A better patient experience translates to higher compliance and more consistent data collection. 🔬 Because Dreem 3S eliminates the "first night" effect, baseline sleep data is more reliable from the start (second image). In contrast, the unfamiliar lab environment of PSG often disrupts sleep on the first night, potentially skewing results. By improving usability and reducing study complexity, Dreem 3S enables more scalable, patient-friendly, and data-rich CNS clinical trials. Contact us to learn more about the Deem 3S EEG Headband: https://lnkd.in/errYwFaE #EEG #CNSDrugDevelopment #SleepResearch #ClinicalTrials #PrecisionMedicine 

🌙 It’s World Sleep Day! While we often think of sleep as a time for rest and cognitive recovery, it’s also a powerful window into brain activity and overall health. Sleep patterns can reveal underlying neurological and systemic conditions—sometimes years before other symptoms appear—making it a critical focus for disease research and treatment. 𝗪𝗵𝘆 𝗦𝗹𝗲𝗲𝗽 𝗠𝗮𝘁𝘁𝗲𝗿𝘀 𝗶𝗻 𝗗𝗶𝘀𝗲𝗮𝘀𝗲 𝗥𝗲𝘀𝗲𝗮𝗿𝗰𝗵  Sleep is a structured neurophysiological state that provides a unique opportunity to detect changes linked to primary sleep disorders, CNS diseases, secondary sleep disorders, and therapeutic interventions. Understanding these changes can drive breakthroughs in research and treatment development in the following areas: 🔹 Primary Sleep Disorders  Conditions like obstructive sleep apnea (OSA), narcolepsy, and idiopathic hypersomnia impact millions, often going undiagnosed for years. Left untreated, these disorders can lead to cognitive impairment, cardiovascular disease, and metabolic dysfunction. 🔹 CNS Diseases  Sleep disruptions are closely tied to depression, schizophrenia, bipolar, PTSD, Alzheimer’s, Parkinson’s, and other neurological conditions. Changes in sleep architecture—such as fragmented REM sleep or altered slow-wave activity—can reflect disease progression and even precede clinical symptoms. 🔹 Secondary Sleep Disorders  Chronic conditions like pain, inflammatory bowel disease (IBD), and atopic dermatitis often lead to severe sleep disturbances, which in turn exacerbate inflammation, pain perception, and immune function, creating a cycle that worsens overall health. 🌍 This #WorldSleepDay wraps up National Sleep Foundation's Sleep Awareness Week, a time to recognize that sleep is more than just a necessity—it’s a key to understanding disease and improving long-term health outcomes. #SleepHealth #WorldSleepDay #SleepAwarenessWeek #Neuroscience #CNSResearch #BrainHealth

𝗔𝗻𝗱 𝘁𝗵𝗮𝘁’𝘀 𝗮 𝗥𝗔𝗣(𝗦)! 𝗔𝗹𝗲𝘅 𝗖𝗵𝗮𝗻 𝗽𝗿𝗲𝘀𝗲𝗻𝘁𝗲𝗱 𝗮𝘁 𝘁𝗵𝗲 𝗥𝗔𝗣𝗦 𝗰𝗵𝗮𝗽𝘁𝗲𝗿 𝗺𝗲𝗲𝘁𝗶𝗻𝗴 𝗹𝗮𝘀𝘁 𝘄𝗲𝗲𝗸 𝗼𝗻 𝘁𝗵𝗲 𝗹𝗮𝘁𝗲𝘀𝘁 𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁𝘀 𝗳𝗿𝗼𝗺 𝘁𝗵𝗲 𝗙𝗗𝗔 𝗮𝗿𝗼𝘂𝗻𝗱 𝗣𝗖𝗖𝗣 𝗮𝘂𝘁𝗵𝗼𝗿𝗶𝘇𝗮𝘁𝗶𝗼𝗻. 𝗛𝗲𝗿𝗲’𝘀 𝘄𝗵𝗮𝘁 𝘄𝗲 𝗹𝗲𝗮𝗿𝗻𝗲𝗱. Regulatory frameworks for AI-driven medical devices are evolving rapidly, and staying ahead of these changes is critical. Our VP of Analytics and Machine Learning, Alexander Chan, recently spoke at a RAPS Indiana Chapter meeting about the latest FDA guidance on Predetermined Change Control Plans (PCCPs)—a key component of AI/ML-powered medical device submissions. The final 2024 FDA guidance introduced several notable changes from the draft version earlier in the year: 🔹 𝗥𝗲𝗳𝗶𝗻𝗲𝗱 𝗹𝗮𝗻𝗴𝘂𝗮𝗴𝗲 𝗼𝗻 𝗶𝗻𝗱𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀 𝗳𝗼𝗿 𝘂𝘀𝗲 → More flexibility in how devices can be positioned.  🔹 𝗦𝘁𝗿𝗼𝗻𝗴𝗲𝗿 𝗰𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 𝗲𝗻𝗳𝗼𝗿𝗰𝗲𝗺𝗲𝗻𝘁 → PCCP authorization can be withheld if a manufacturer has a history of non-compliance.  🔹 𝗚𝗿𝗲𝗮𝘁𝗲𝗿 𝗲𝗺𝗽𝗵𝗮𝘀𝗶𝘀 𝗼𝗻 𝗹𝗮𝗯𝗲𝗹𝗶𝗻𝗴 → Ensuring transparency in PCCP updates.  🔹 𝗡𝗲𝘄 𝗲𝘅𝗽𝗲𝗰𝘁𝗮𝘁𝗶𝗼𝗻𝘀 𝗳𝗼𝗿 𝗰𝗼𝗻𝘁𝗶𝗻𝘂𝗼𝘂𝘀 𝗱𝗮𝘁𝗮 𝗰𝗼𝗹𝗹𝗲𝗰𝘁𝗶𝗼𝗻 → Ongoing performance evaluation is now recommended. A key takeaway? The FDA continues to proactively refine its approach, collaborating with innovators, and making regulatory submissions more interactive throughout the process. Check out our VP’s recommendation for a PCCP submission and read more about how Beacon Biosignals' two PCCPs below.  🔗 Beacon's Dreem 3S PCCP Clearance: https://lnkd.in/ghZ-fcMu 🔗 Beacon's SleepStageML Clearance: https://lnkd.in/g_2bWkGG #AIinHealthcare #RegulatoryAffairs #MachineLearning #MedicalDevices #FDA #PCCP