Scandinavian Real Heart’s Post

Landmark moment for us at Beacon Biosignals: Receiving the FDA's first authorization for a sleep wearable PCCP permits us to deploy the latest algorithmic innovations in support of analyzing patient data. The FDA's bold and forward-looking program to unlock the value of AI in medical device development will offer enormous benefit as we tackle a range of psychiatric and neurological diseases, from Major Depression to Alzheimer's and more. Special congrats to Alexander, Jarrett, and the entire AI & Machine Learning team at Beacon for this achievement.

📣 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

💡 Atrial Fibrillation (AF): A Call for Prevention and Early Intervention 💡 Atrial fibrillation (AF) is a devastating disease, contributing to heart failure and significantly decreasing quality of life—particularly for women, who face disproportionately severe impacts. Early detection and prevention are critical to improving outcomes before AF develops. A new, large retrospective study (~50% women) published in the Journal of the American Heart Association highlights a key risk factor: time spent with oxygen saturation under 90% during sleep strongly increases the risk of developing AF. The good news? This metric can now be easily tracked using modern wearable devices, potentially opening the door for earlier interventions and better prevention strategies. With the growing accessibility of these technologies, could this be the next frontier in AF risk reduction? If you’re interested in the intersection of sleep, cardiology, and preventive care this article is worth reading. #AtrialFibrillation #Cardiology #SleepMedicine #PreventiveCare #WomenInMedicine #Research

💤 Just how important is sleep? In new findings published by Icahn School of Medicine at Mount Sinai it has been found that the heart communicates with the brain after a heart attack via the immune system to promote more sleep. This research underlines just how important sleep is to effective cardiac recovery and suggests that sufficient sleep should be a focus of post-heart-attack clinical management and care, in intensive care units, where sleep is frequently disrupted, along with cardiac rehabilitation. "This study is the first to demonstrate that the heart regulates sleep during cardiovascular injury by using the immune system to signal to the brain. Our data show that after a myocardial infarction (heart attack) the brain undergoes profound changes that augment sleep, and that in the weeks following a myocardial infarction, sleep abundance and drive is increased," - Cameron McAlpine, Assistant Professor of Medicine (Cardiology) Read the full article in the comments below 👇 #Sleep #Cardiology #SleepResearch #Medexec #MedTechNews

Non-invasive Neuromodulation with scientific evidence We are pleased to announce the publication of a new preliminary study on the effects on sleep and recovery processes of the application of the NESA® Non Invasive Neuromodulation technique in young professional basketball players. This study concludes that NESA® Non Invasive Neuromodulation appears to be an effective treatment to improve the quality of sleep during the night, specifically in the REM phase, in elite athletes. This opens up an interesting avenue of research into neuromodulation of the autonomic nervous system and its relationship to sleep quality as an integral part of daily recovery techniques in professional sport. Although the data should be taken with caution, given the preliminary nature of the study, NESA® Non-Invasive Neuromodulation is postulated as a promising approach to simply and superficially modulate endogenous autonomic function and improve sleep quality. 🔬 Access to the scientific poster 👉 https://lnkd.in/dQbSidJP Congratulations to the whole team that carried out this new study! A team led by Dr. Raquel Irina Medina Ramírez. NESA® medical technology, non-invasive neuromodulation based on solid scientific evidence. #NESA hashtag #NESAWORLD hashtag #NESAMedicalTechnology hashtag #NESA hashtag #NonInvasiveNeuromodulation hashtag #AutonomousNervousSystem hashtag #CareyourAutonomousNervousSystem hashtag #ScientificStudy hashtag #ScientificEvidence #EliteSport

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Neurosom's research partner, the Brain Electrophysiology Lab (BEL), has received $2.2 million in Phase II funding from the National Institutes of Aging to conduct an FDA-monitored clinical trial to determine if Neurosom's Electric Sleep Therapy can improve deep sleep and memory consolidation in seniors with Mild Cognitive Impairment (MCI).  In the Phase I feasibility study, Neurosom scientists, together with colleagues at Wake Forest University (led by Dr. Ruth Benca) and the Portland Veterans Administration Research Foundation (led by Dr. Miranda Lim), demonstrated the ability to train seniors diagnosed with MCI to use the Neurosom Sleep WISP system in their homes to collect EEG (brain waves) and automatically deliver the electrical synchronization therapy to enhance deep sleep. This feasibility study was reviewed by the NIA program officer and found to be successful, thereby warranting the funding for the Phase II (pivotal) clinical trial. Neurosom scientists are planning an investor webinar in the near future to provide updates on progress in the preparation and launch of the clinical trial.  Neurosom remains committed to testing its Electric Sleep Therapy in adults with insomnia, and plans to fund an FDA clinical trial with capital raised over the RedCrow platform.  For investors, the NIA decision to provide non-dilutive funding for the MCI clinical trial provides important validation of the Phase I feasibility study results and advances the incremental de-risking of the investment opportunity. www.neurosom.net #sleep #sleeptherapy #sleep2024

📣 New Regulatory Milestone for Beacon Biosignals! 📣 We're proud to announce that Beacon's SleepStageML algorithm has received FDA 510(k) clearance for automated sleep staging, harnessing the EEG signals from traditional in-lab polysomnography! No matter where your clinical trial is measuring sleep, we’ve now got you covered! This latest milestone complements our 510(k)-clearance of the Dreem 3S EEG headband, extending our at-home monitoring capabilities to now also comprehensively support sleep staging for traditional in-lab studies via SleepStageML. SleepStageML introduces a standardized, expert-level automated sleep staging pipeline that: ▪ Improves the signal-to-noise of sleep endpoints for clinical trials ▪ Automates the labor-intensive manual sleep staging process  ▪ Reduces subjective variability in scoring between human experts  ▪ Supports an order-of-magnitude faster PSG analysis turnaround time "With FDA clearances for both SleepStageML and Dreem 3S™ headband, Beacon now provides an unparalleled capability to measure sleep physiology whether studies are conducted in-home or in-clinic," said Jacob Donoghue, MD, PhD, CEO of Beacon Biosignals. "Beacon’s powerful analytics platform allows for rich analysis of clinical datasets across multiple environments to spur innovation in therapies for sleep disorders as well as neurological and psychiatric conditions with sleep comorbidities." Sleep disorders impact millions of individuals with neurological conditions, psychiatric illnesses, and beyond. With FDA 510(k) clearances for both our Dreem 3S device and our SleepStageML, we are now better equipped than ever to evaluate sleep dysfunction in neuropsychiatric diseases and help uncover novel therapeutic approaches and meaningful endpoints in clinical trials. Read the full press release: 🔗 https://lnkd.in/gpeENPYD Reach out to learn how you can bring sleep endpoints to your trials: 🔗 https://lnkd.in/errYwFaE #FDAClearance #algorithms #sleep #endpoints #EEG #PSG #Dreem #biosignals

Wearable respiratory sensors are opening new frontiers in neonatal clinical trials. By providing continuous, real-time data on infant respiratory health, these sensors allow for safer, more precise interventions and a deeper understanding of early development. VivoSense is leading the way in interpreting this critical data to support innovative, life-changing research for our youngest patients. Learn more about the advantages of respiratory sensors in neonatal trials! Read Now: https://hubs.la/Q02Xw5Cl0 #clinicalresearch #clinicaltrials #digitalendpoints #digitalbiomarkers

Nyxoah enters the UK as their "Genio" Neurostim device for OSA Launches in England, with the first two patients receiving successful implants at University College London Hospitals NHS Foundation Trust Genio is covered under the NHS Specialised Services Devices Programme, ensuring access to the therapy through specialized centers of excellence. Nyxoah are also pursuing FDA approval in the US. #marketaccess #neuromodulation #neurostimulation https://lnkd.in/edzc3GvR