Beacon Biosignals

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

SYNGAP Research Fund x Beacon Biosignals: Advancing ASO Therapy with EEG We’re proud to partner with the incredible team at SynGAP Research Fund (SRF) for SYNGAP1-Related Disorders as they push forward groundbreaking research and advocacy for patients with SYNGAP1. SRF’s research team is using Beacon’s FDA 510(k)-cleared EEG headband to assess sleep biomarkers in specific patient populations receiving novel ASO (antisense oligonucleotide) therapies for SYNGAP1. Recently, Beacon Biosignals’ Medical Director, Jay Pathmanathan, MD, PhD, presented on how SRF is using EEG data to: 🧠 Identify optimal candidates for ASO therapy trials with real-time brain activity insights. 🧠 Predict seizure risks and treatment responses using EEG-driven biomarkers. 🧠 Accelerate trial timelines—shifting insights from years to hours. By integrating genetic insights with EEG technology, we’re enhancing ASO therapy trials—ensuring both safety and efficacy for those who need it most. 📺 Watch Dr. Pathmanathan’s full webcast & learn more about SRF’s innovative work:  https://lnkd.in/gKTdNBYq #ASOTherapy #EEG #PrecisionMedicine #SYNGAP1 #EpilepsyResearch #ClinicalTrials #Neurotech

“I’m tired of having hope— I want a cure.” This powerful quote from a caregiver of someone living with a rare disease resonates deeply with me and drives everything we do at Beacon Biosignals. The lived experiences of patients and caregivers facing the unimaginable are the motivation behind our work. We know that cures come from data, and we’re accelerating our efforts because speed is critical for these families. I’ve heard firsthand the traumatic stories about the obstacles patients face just to get EEGs and sleep monitoring (e.g. the screaming during the hour it takes to apply the electrodes, the gel and glue in hair for weeks, the 3 months wait until getting EEG scheduled, the electrodes falling off and needing to reschedule *another* 3 months later, the physical restraints placed to hold down a screaming child during application, the list goes on….) That’s why I’m proud of the role we’re playing in ensuring every patient’s brain can be analyzed and understood easily, at-home, and applied by patients themselves and their caregivers. Next up: Characterizing brain activity and sleep physiology in #SYNGAP1 and pushing to get new treatments to patients faster than ever. It’s time for a cure!

Exciting news! Beacon Biosignals is expanding our industry-leading Clinical Operations team to further support our biopharma partners in integrating EEG technology into early- and late-stage clinical trials. From trial design to data analysis and delivery, we ensure the highest-quality data to drive better clinical outcomes. This week we’re thrilled to welcome Emily Mitchell as our new Vice President of Clinical Study Operations! Emily joins Beacon from ICON plc where she served as VP, General Parter and former head of the Decentralized Clinical Trials team. She brings extensive experience in operational oversight and department scaling, enhancing operational processes and market presence, and support of cross functional business development activities. Emily is looking forward to growing Beacon's study operations and supporting a growing client relationship base.    Interested in joining Beacon Biosignals? We’re hiring brilliant minds to help us build the future of precision neuroscience. Check out our careers page for more! https://beacon.bio/careers 

🚨 Last chance to register: Navigating FDA PCCP Authorization for AI-Driven Medical Devices 🚨 Tune in tomorrow, February 27, from 4:30-6:00 PM ET to a webcast hosted by the Regulatory Affairs Professionals Society, RAPS Indiana Chapter! The talk will focus on navigating the FDA’s latest guidance on Predetermined Change Control Plans (PCCPs) for AI-driven medical devices. 🔹 𝗙𝗲𝗮𝘁𝘂𝗿𝗲𝗱 𝗦𝗽𝗲𝗮𝗸𝗲𝗿:  Alexander Chan, PhD, VP of Analytics and Machine Learning at Beacon Biosignals Prior to joining Beacon, Alex led the Health Technologies algorithm team at Apple, delivering sleep tracking for the Apple Watch and developing groundbreaking machine learning models for next-gen sleep sensing. He holds a PhD in Medical Engineering and Medical Physics from the Harvard/MIT Division of Health Sciences. 🔹 𝗪𝗵𝗮𝘁 𝘁𝗼 𝗘𝘅𝗽𝗲𝗰𝘁:  • Insights on regulatory pathways for AI in healthcare, including the significance of PCCP clearance  • Strategies for continuous innovation in medtech and key factors the FDA evaluates when assessing PCCPs for AI-enabled medical devices • Live Q&A with Alex on Beacon’s experience achieving two PCCP clearances 🔹 𝗛𝗼𝘄 𝘁𝗼 𝗔𝘁𝘁𝗲𝗻𝗱:  This event is open to both members and non-members of RAPS. 📍 Attend in person: Barnes & Thornburg, Indianapolis  💻 Join virtually: Link will be provided before the event 🚀 Secure your spot now! Register here: https://lnkd.in/gjfKdmMU #AI #MedicalDevices #RegulatoryAffairs #FDA #MachineLearning #PCCP