Beacon Biosignals

?????? ????????’?? ?? ??????(??)! ???????? ???????? ?????????????????? ???? ?????? ???????? ?????????????? ?????????????? ???????? ???????? ???? ?????? ???????????? ???????????????????????? ???????? ?????? ?????? ???????????? ???????? ??????????????????????????. ????????’?? ???????? ???? ??????????????. 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: ?? ?????????????? ???????????????? ???? ?????????????????????? ?????? ?????? → More flexibility in how devices can be positioned.? ?? ???????????????? ???????????????????? ?????????????????????? → PCCP authorization can be withheld if a manufacturer has a history of non-compliance.? ?? ?????????????? ???????????????? ???? ???????????????? → Ensuring transparency in PCCP updates.? ?? ?????? ???????????????????????? ?????? ???????????????????? ???????? ???????????????????? → 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. ?? ???????????????? ??????????????:? 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. ?? ???????? ???? ????????????:? ? 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 ?? ?????? ???? ????????????:? 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

“Neuroscience...stands out as a therapeutic area that greatly benefits from the incorporation of wearables due to the limitations of current subjective and infrequent endpoints and biomarkers... This creates a strong need to gather more objective data to support better-informed clinical decisions. Furthermore, the shift from merely treating symptoms to implementing disease-modifying approaches demands a precision and understanding that current clinical or cognitive biomarkers simply cannot provide.” In a recent Clinical Tech Leader interview, Bryan J. Hansen, Ph.D., Director of Innovative Health at Johnson & Johnson Innovative Medicine, discusses why scalability, reduced participant burden, real-world insights, and clinically rigorous, objective data make wearables, particularly sleep measurement, essential for decentralized neuroscience trials. Read the full interview here: https://lnkd.in/ejhSWrN6 #Neuroscience #Wearables #DecentralizedTrials #CNSDrugDevelopment

???????????? ???????????? ????????: ?????? ?????????? ???????? ???????????? ?????? ??????-??/?????? ???????? ??????????????????????? With the market for GLP-1/GIP receptor agonists rapidly expanding, how can new treatments stand out? The key may lie in parallel treatment of interrelated comorbidities based on secondary clinical endpoints, potentially improving quality of life for patients while expanding drug labeling. ???????? ?????????????????????? ?????????? ?????????? (??????): ??? Affects 40%+ of adults with BMI >30—and up to 90% in cases of severe obesity (Patial et. Al., 2023) ??? Impacts sleep fragmentation, energy levels, and metabolic health ??? Regulators like the FDA already accept EEG-based sleep endpoints in Phase 3 trials and drug labeling (e.g., Wake After Sleep Onset, Sleep Efficiency) ???? ?????????????????????????? ?????????? ???????????????????? ???? ???????????????? ????????????, ???????? ???????????????????? ??????:? ?1. Optimize trial design through better patient stratification? ?2. Expand drug labeling into CNS disorders affecting sleep quality?? ?3. Use at-home EEG to make sleep tracking easier, cheaper, and scalable? Check out this article on how Skye Bioscience Inc. is integrating sleep endpoints in their Phase 2 trial of Nimacimab for obesity to provide a more comprehensive assessment of its therapeutic potential: https://lnkd.in/d9WET6FN Measuring sleep physiology isn’t just about collecting more trial data—it’s about demonstrating novel, clinically meaningful endpoints to better differentiate in an increasingly competitive GLP-1/GIP market. #EEG #GLP1 #GIP #incretin #OSA #CNSDrugDevelopment #Biopharma

???????????????????? ???????????? ???????? ??????????????: ?????? ???????? ?????? ?????? ???? ?????????? ???????????????? A recent study in npj Digital Medicine highlights a key issue in sleep and depression research: ???????????????? ???????????????? ?????????? ???????????????? ???????? ????????????????????????, ?????????? ?????????????????? ???????? ???? ????????????????????, ?????????? ??????’?? ?????????? ???????? ????????-???????????????? ?????????? ??????????????.?This is particularly true for non-neurotypical sleepers, on which wearable algorithms typically aren’t trained. The primary reason for the discordance is that ???????????????????? ???????????????? ????????????????, ?????? ?????????? ????????????????. While useful for tracking general sleep-wake cycles, actigraphy doesn't capture core sleep stages (N1, N2, N3, and REM sleep), let alone microarchitectural and spectral physiology data. This is a major gap, as certain sleep stages—such as Slow Wave Sleep and REM—are strongly correlated with depression severity and cognitive function. Without direct brain measurement, neurophysiological insights are lost. It gets worse: because actigraphy is typically trained on neurotypical subjects, algorithms wrongly classify wake and sleep in non-neurotypical subjects. In the two charts representing individual clinical trial participants, we see wrist actigraphy misses large swaths of nighttime wakefulness (green) as well as individual sleep stages (pink, blue, and purple) when compared to PSG data collected in a traditional context and using Beacon's Dreem headband. Through Beacon’s FDA 510(k) clearance, the Dreem EEG headband is equivalent to polysomnography (PSG) for the physiological assessment of sleep. Self-reported sleep measures can provide valuable context, but they have limitations—especially in clinical and research settings. When incorporating physiological data into sleep research for neurologic and CNS disorders, EEG is essential for ensuring accuracy and validity. Read the full paper on the discordance of self ?report sleep measures and actigraphy: https://lnkd.in/ersqtytt Learn more about Beacon's Dreem headband: https://lnkd.in/ei9DrihM #SleepData #DigitalBiomarkers #EEG #Actigraphy #MDD #MentalHealth

?? New Research Review by Beacon Biosignals Underscores Link Between Sleep and Alzheimer’s Disease with Slow Wave Sleep as a Major Biomarker ?? Sleep disturbances don’t just correlate with Alzheimer’s disease (AD)—they may actively contribute to its progression. Our latest research review, published in Frontiers, reinforces the role of sleep, particularly slow wave sleep (SWS), in clearing toxic metabolic waste from the brain—a process that may be key to slowing neurodegeneration. What we find most interesting: SWS enhances glymphatic clearance, flushing out beta-amyloid and phosphorylated tau—proteins that drive AD pathology. Disruptions in SWS impair this process, potentially accelerating disease progression. For those looking to develop treatments for neurodegenerative disorders, here’s why this matters: 1. Reductions in SWS and slow-wave activity appear years before clinical AD symptoms, making SWS a crucial biomarker for early detection. 2. Sleep disorders like insomnia, sleep apnea, and circadian misalignment increase AD risk, offering an opportunity to stratify patients with these co-morbidities during drug development. 3. Understanding these mechanisms could lead to novel strategies for prevention and treatment, particularly with precision approaches to addressing the underlying pathophysiology. ?? Read the full review here: https://lnkd.in/evNTh-wM ?? A huge congratulations to authors Jay Pathmanathan, Brandon Westover, Sudhir Sivakumaran, Ph.D., Jacob Donoghue, MD PhD, and Corey Puryear, some of the amazing team that helps lead neuroscience research at Beacon Biosignals. Have questions about the research? We have answers (and we love to discuss). Ask below or message us for more! #AlzheimersResearch #SlowWaveSleep #EEG #Neurodegeneration #PrecisionMedicine?

We’re excited to welcome Leticia Soto to the Beacon team as our new Vice President of Quality! Lety joins Beacon from PathAI where she served as VP of Quality and Compliance for all regulated products, including medical devices and clinical trial products. She brings extensive experience in compliance programs including Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), and European regulations. Lety is most excited to expand Beacon's compliance programs and regulated product offerings. 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? #QualityLeadership #Neuroscience #PrecisionMedicine #AIinHealthcare #JoinOurTeam #NowHiring?