Generated: 2026-04-06 08:24 UTC
| Latest News | NSF awarded $500K SBIR Phase IIB grant to advance stroke detection wearable (Jun 2025). Named CTIA Wireless Foundation Catalyst 2025 Finalist for 5G/wireless technology innovation. link |
| Funding | Raised $500K NSF SBIR Phase IIB grant (Jun 2025), previously received ~$1.5M NIH SBIR funding and $12K American Heart Association grant (Nov 2024). Total funding $1.23M according to PitchBook. link |
| Clinical Trials | NA · n=10 (ESTIMATED) · Est. completion: 2025-12 Sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro + Università Campus Bio-Medico di Roma (UCBM), Scuola Superiore Sant'Anna di Pisa Primary endpoints:
Sites: Centro Protesi Inail, Budrio, Italy Inclusion: Inclusion Criteria:
* age between 18 and 65 years
* post-stroke or brachial plexus injuries patients
* upper limb motor deficit patients with Medical Research Council (MRC) Scale for Muscle Strength ... | Exclusion: Exclusion Criteria:
* other nuerological or orthopaedic impairments
* pain in injuried upper limb (Numeric Rating Scale (NRS) higher than 4)
* cognitive impairments (Mini-Mental State Examination (MM... NOT_YET_RECRUITINGScalp Acupuncture Combined With rTMS for Upper Limb Motor Dysfunction in Stroke: A Brain Network Study NA · n=44 (ESTIMATED) · Est. completion: 2027-05-30 Sponsor: Debiao Kong Primary endpoints:
Sites: the Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China Inclusion: Inclusion Criteria:
* Meet the diagnostic criteria for stroke (symptoms and signs, imaging indicators, etc.), and are independently diagnosed by two deputy chief physicians
* Age 18-70 years old, fir... | Exclusion: Exclusion Criteria:
* Severe visual impairment, hemispatial neglect, body image disorder
* Individuals who cannot undergo rTMS treatment due to reasons such as metal implants, cardiac pacemakers, or ... |
| Regulatory | Planning De Novo FDA submission summer 2026, targeting full FDA approval by 2028. De Novo pathway allows early market access to limited patient pool before full approval. link |
| Product Updates | Wearable provides continuous 24/7 monitoring for up to 90 days, detects hemiparesis through bilateral IMU sensors, connects to 24/7 call center for emergency response. Pilot deployments in senior living communities completed. link |
| Patents & IP | Claims to have 'patented wearables' but no specific patent numbers or publications found in recent searches. link |
| Publications | Accounting for Truncation Artifacts in Angiographic Perfusion. DOI Lyman KA, Hebert RM, Matouk CC et al. · Translational stroke research · 2026 Mar 12 Enhanced Detection of Acute Ischemic Stroke With Low-Field MRI. DOI Sorby-Adams A, Pinter NK, Demopoulos A et al. · Stroke (Hoboken, N.J.) · 2026 Mar Major publications in the critical care pharmacotherapy literature: 2025. DOI Highsmith EA, Arellano D, Bash K et al. · Journal of critical care · 2026 Mar 3 Apixaban Versus Aspirin and Risk of Hemorrhage in the ARCADIA Trial. DOI Kamel H, Longstreth WT Jr, Tirschwell DL et al. · Annals of neurology · 2026 Feb 25 On the accuracy of image registration in portable low-field 3D brain MRI. DOI Iglesias JE, Johnson IP, Williams-Ramirez J et al. · bioRxiv : the preprint server for biology · 2026 Feb 13 |
| Marketing | CEO Sandra Saldana giving closing keynote at MEDTEQ+ Health Innovation Summit 2026 (Jan 2026). Regular speaking engagements at healthcare innovation events. link |
| Customer Traction | Pilot deployments in senior living communities and remote patient monitoring studies completed. No specific hospital partnerships or commercial contracts disclosed. link |
| Team & Hiring | Team remains at 6 employees per PitchBook. Co-founded by Sandra Saldana (CEO), Dr. Kevin Sheth (Chief Medical Adviser), Dr. Hitten Zaveri (Chief Technical Advisor). link |
| Key Weakness | Measures downstream motor symptoms (hemiparesis) rather than the hemodynamic cause of stroke. Requires patient to already have functional impairment vs detecting pre-symptomatic vascular changes. Limited to detecting strokes that cause motor asymmetry. |
| Vibrant Counter | Vibrant detects carotid blood flow changes BEFORE any motor symptoms appear, providing earlier intervention window. Measures the hemodynamic cause (occlusion) vs downstream consequence (weakness). Bilateral carotid monitoring catches all stroke types, not just those causing arm weakness. |
| ⚡ 90-Day Watch | Monitor De Novo FDA submission timeline (planned summer 2026), New York clinical trial enrollment and interim results, additional grant funding announcements, and hospital partnership developments as they approach commercialization. |
| Latest News | Due to current war-related circumstances, Avertto has had difficulty in securing additional investments, and recently downsized to three people from its initial team of 12, hiring subcontractors for additional help (Oct 2024). The startup decided to honor Mann's memory by naming its first commercial product after her — a life-saving, wearable device for detecting early signs of stroke (Oct 2024). |
| Funding | The company is seeking FDA approval after having secured $2 million in grants and started seed-round fundraising (Oct 2024). Avertto hits its first-year targets, gaining an additional 5M ILS for their innovative stroke monitoring tech. The company has raised $2 million in funding and is seeking $0.5M match funding for that last IIA grant (Mar 2024). |
| Clinical Trials | NA · n=600 (ESTIMATED) · Est. completion: 2028-03-16 Sponsor: Centre Hospitalier St Anne + Direction Générale de l'Offre de Soins Primary endpoints:
Sites: Centre hospitalier Sainte-Anne, Paris, France Inclusion: Inclusion Criteria:
* Patient age 18 years or over
* Hemispheric or retinal transient ischemic attack or a non-disabling stroke (or retinal infarct) within 15 days before enrolment
* Stenosis of 50% ... | Exclusion: Exclusion Criteria:
* Patients unwilling or unable to participate in follow-up for whatever reason
* Preexisting disability (Modified Rankin Score ≥ 3)
* Nonatherosclerotic carotid disease
* Severe t... COMPLETEDSuccess of Endodontic Regenerative Approaches in Anterior and Posterior Immature Non Vital Teeth NA · n=40 (ACTUAL) · Est. completion: 2025-06-01 Sponsor: Future University in Egypt Primary endpoints:
Sites: Future University in Egypt, Cairo, Egypt Inclusion: Inclusion Criteria:
* • Age 8-15.
* Medically free.
* Single rooted immature necrotic permanent teeth.
* Tooth without vertical root fracture or resorption.
* Compliant patient/parent.
* P... | Exclusion: Exclusion Criteria:
* Avulsed teeth immediately after replantation (as revitalization may occur naturally).
* Luxation injuries.
* Impossibility of adequate tooth isolation.
* Teeth with extensive lo... |
| Regulatory | The company is seeking FDA approval after having secured $2 million in grants (Oct 2024). No specific FDA milestone updates found beyond general approval-seeking status. |
| Product Updates | Sensors - sensitive passive pressure sensors and a small wireless controller for continuous carotid recording. Algorithm Development: highly accurate first threshold algorithm for detecting large vessel occlusion (Feb 2024). Using 40% threshold probability, 100% accuracy LVOs detected. No false alarms. |
| Patents & IP | Avertto Medical received funding from the Israeli Innovative Authority (81656) and EIC (WomenTech) publication (2024). No specific patent filings found in search results. |
| Publications | Natural Language Processing to Automate Cerebrovascular Event Identification in Stroke Alerts. DOI Erekat AN, Stein LK, Delman BN et al. · Stroke (Hoboken, N.J.) · 2025 Nov The Stroke Alert Project: A Longitudinal Evaluation of a School-Based Stroke Knowledge Intervention. DOI Santos C, Azevedo AR, Morete NA et al. · Cureus · 2025 Dec Early Detection of Large Vessel Occlusions by Bilateral Carotid Pressure Monitoring: Blinded Observational Study. DOI Ben-Pazi H, Elmalich L, Lavi Y et al. · Stroke · 2026 Jan Pediatric acute stroke alert in Nantes and Angers hospitals: description of patients included and comparison with published data. DOI Le Bricquir F, Gueden S, Loisel D et al. · Archives de pediatrie : organe officiel de la Societe francaise de pediatrie · 2026 Jan Nursing-Led Quality Improvement Project Achieves 30-Minute Door-to-Needle Time. DOI Powell K, Hebb A, Hackett CT · Journal of emergency nursing · 2025 Nov 21 |
| Marketing | Avertto claimed the Asper Prize from Hebrew University's ASPER-HUJI Innovate, winning NIS 100,000 for their stroke-preventing technology. StrokeAlert is chosen as one of the 5 finalists in the Aviram Awards from 780 startups. Chosen among 85 women-led startups for a 75K Euro EIC grant. |
| Customer Traction | It is running blind clinical studies in 7 clinical sites around the world in countries like Israel, Spain, and the US (Mar 2024). In the US, Avertto leverages ICU disposable reimbursements up to $5,000, strategically setting a sale price at $847 per patient for up to one week of use. |
| Team & Hiring | Recently downsized to three people from its initial team of 12, hiring subcontractors for additional help (Oct 2024) - negative hiring signal indicating significant staff reduction due to funding challenges. |
| Key Weakness | Due to current war-related circumstances, Avertto has had difficulty in securing additional investments, and recently downsized to three people from its initial team of 12. Significant operational disruption and funding challenges affecting core team size and commercial progress. |
| Vibrant Counter | Avertto's pulse-wave detection only captures downstream hemodynamic changes vs. Vibrant's direct bilateral carotid ultrasound measuring the actual occlusion source. Their neck patch positioning may suffer from motion artifacts and inconsistent sensor contact, while our bilateral design enables side-to-side asymmetry detection that pulse waves cannot provide. Their team downsizing to 3 people severely limits execution capacity vs. our full development team. |
| ⚡ 90-Day Watch | Monitor for: 1) Seed funding round closure status amid reported difficulties, 2) FDA pre-submission filing timeline, 3) Team expansion announcements indicating funding recovery, 4) Clinical trial enrollment progress at 7 global sites, 5) Real-time alert validation study results mentioned in ESO presentation. |
| Latest News | Forest Devices received FDA 510(k) clearance for its SignalNED Model RE system in September 2024 (Sep 2024) link |
| Funding | Forest Devices raised a total of $9.61M with latest funding round being Seed - IV (Date Unknown) link |
| Clinical Trials | The EDGAR study showed that AlphaStroke was 28% to 40% superior to the clinical exams currently used by medics in the field at correctly identifying patients with LVO (Published Feb 2021) link |
| Regulatory | Forest Devices received FDA 510(k) clearance for its SignalNED Model RE system in September 2024 and has FDA Breakthrough Device designation for its AlphaStroke technology (May 2021) link |
| Product Updates | The company plans a limited launch this year as they continue to enhance their platform for the newly FDA-cleared SignalNED Model RE system (Sep 2024) link |
| Patents & IP | No data found |
| Publications | "Portable Neuromonitoring Device Detects Large Vessel Occlusion in Suspected Acute Ischemic Stroke," by Paulina B. Sergot, MD, et al is available online in Stroke (Feb 2021) link |
| Marketing | "Our objective is to offer patients facing acute neurological issues timely, objective, and real-time information from the very start of their interaction with healthcare providers" - CEO Laura Lyons (Sep 2024) link |
| Customer Traction | No data found |
| Team & Hiring | Forest Devices CEO Laura Lyons appears to be a relatively new CEO based on recent announcements, suggesting potential leadership changes (Sep 2024) link |
| Key Weakness | Forest Devices appears to have pivoted from their bioimpedance-based AlphaStroke technology to EEG-based SignalNED system, suggesting potential challenges with their original stroke detection approach |
| Vibrant Counter | Vibrant's continuous bilateral carotid ultrasound directly measures hemodynamic changes at the source of stroke, while Forest's EEG approach only detects downstream electrical changes in the brain after damage has already begun - we monitor the cause, not the consequences |
| ⚡ 90-Day Watch | Monitor for commercial launch updates of SignalNED system and any pivot back to AlphaStroke development, as the company has two distinct technological approaches in development |
| Latest News | CVAID achieved USPTO patent grant for 'Systems and methods for diagnosing a stroke condition' (patent 11699529) and received ISO 13485 certification link |
| Funding | Last funding round was Series A of $4M in Feb 2022 led by Rad Biomed with participation from Philips, Sanara Capital for FDA and CE regulatory processes link |
| Clinical Trials | Multi-center clinical trial 'A multi-center, non-interventional prospective clinical trial to evaluate the safety and effectiveness of CVA-Flow' sponsored by CVAid Medical and initiated largest clinical trial at Shaare Zedek Medical Center led by Dr. Roni Eichel link |
| Regulatory | CVAid stated strategic plan includes completing regulatory processes with FDA and CE (Feb 2022) - no recent updates found link |
| Product Updates | Achieved ISO 13485 certification aligning with mission to improve patient outcomes and company enthusiastic about bringing CVA Flow to market soon link |
| Patents & IP | USPTO patent 11699529 granted for 'Systems and methods for diagnosing a stroke condition' recognizing AI powered stroke detection features and CVAid Medical has filed 1 patent total link |
| Publications | No data found |
| Marketing | Presented at #WSC2023 Philips' symposium with positive impact on stroke care link |
| Customer Traction | Clinical trial collaboration with Shaare Zedek Medical Center, Jerusalem link |
| Team & Hiring | No data found |
| Key Weakness | Platform relies on smartphone-based video/audio analysis rather than direct physiological monitoring, making it dependent on visual symptoms rather than underlying hemodynamic changes link |
| Vibrant Counter | CVAid's approach detects stroke symptoms after they manifest, while Vibrant monitors the actual hemodynamic cause before symptoms appear. CVAid requires visible/audible symptoms for AI analysis, missing the critical pre-symptomatic window that Vibrant's continuous bilateral carotid monitoring captures. |
| ⚡ 90-Day Watch | Monitor for FDA/CE regulatory submission updates, clinical trial results from Shaare Zedek collaboration, and any pivot toward direct physiological monitoring technology that could compete more directly with Vibrant's approach. |
| Latest News | UpFront secured $4.3 million funding to commercialize LVOne stroke test (May 2025) link |
| Funding | Total raised $7.09M with Phoenix Investments leading recent $4.3M round (May 2025), with Cambridge Enterprise Ventures and SBRI Healthcare participating link |
| Clinical Trials | Validated with 500+ patients across 6 NHS stroke hospitals in partnership with Newcastle University. Received £500,000 SBRI Healthcare grant for real-world implementation study that commenced in January 2026 link |
| Regulatory | Planning FDA submission via de novo classification request. Has unnamed US study partner in place link |
| Product Updates | Partnership with NordicDx for multiplex lateral flow reader platform (2025). Pilot study with East of England Ambulance Service NHS Trust in Cambridgeshire link |
| Patents & IP | Owns family of patents protecting novel biomarkers for stroke detection. Uses patented diagnostic algorithm link |
| Publications | Evaluating Prehospital Stroke Scales for Large Vessel Occlusion: A Systematic Review and Network Meta-Analysis. DOI Nawabi NLA, Rivera ER, de Wilde D et al. · Neurology · 2026 Feb 24 |
| Marketing | Won 2024 Pitchfest REWIRED competition link |
| Customer Traction | 6 NHS stroke hospitals validated product. Active pilot with East of England Ambulance Service. Developing relationships in Scotland and Wales link |
| Team & Hiring | Adding commercial team members following recent funding. Currently employs 5 people link |
| Key Weakness | Downstream biomarker approach detects stroke after brain damage occurs, unlike Vibrant's upstream hemodynamic monitoring. Limited to large vessel occlusions only, missing other stroke types. |
| Vibrant Counter | Emphasize continuous hemodynamic monitoring vs. point-in-time blood testing. Highlight prevention of brain damage vs. detection after damage. Promote comprehensive bilateral carotid coverage vs. single-test LVO detection. |
| ⚡ 90-Day Watch | FDA de novo submission timeline and US partnership announcement. RADAR study publication. Commercial launch metrics in UK/EU markets. |
| Latest News | New Peer-Reviewed Protocol publication in SN Comprehensive Clinical Medicine introduces SaFER framework using FloPatch for sepsis care (Mar 2026) link |
| Funding | Secured $7.5M CAD venture debt from RBCx (Mar 2025) for scaling operations link |
| Clinical Trials | ACTIVE_NOT_RECRUITINGCombining Physical Activity and Sedentary Interventions to Improve Cardiometabolic Health NA · n=30 (ESTIMATED) · Est. completion: 2026-02 Sponsor: Hasselt University Primary endpoints:
Sites: Univeristeit Hasselt, Diepenbeek, Belgium Inclusion: Inclusion Criteria:
* Age 18 to 65 years
* Profession where most of the time is spent sitting.
* Not regularly physically active (\>3 trainings per week in the last three months)
* Sedentary (on aver... | Exclusion: Exclusion Criteria:
* Pregnancy.
* Consumption of more than 20 units of alcohol per week.
* Medical conditions that limit physical activity.
* Specific diet (e.g. low-carbohydrate or calorie-restrict... N/A · n=6000 (ESTIMATED) · Est. completion: 2028-06-30 Sponsor: Aga Khan University Primary endpoints:
Sites: Matiari Research and Training Centre, Matiari, Pakistan · Mithi Study Site Office, Mithi, Pakistan · Tando Muhammad Khan (TMK) Study Site Office, Tando Muhammad Khan, Pakistan Inclusion: Inclusion Criteria:
* Single or multiple live pregnancy confirmed through ultrasound
* Gestational age less than or equal to 13 weeks and 6 days at enrollment
* At least 18 years of age
* Permanent r... | Exclusion: Exclusion Criteria:
• Plan to relocate outside the district for more than 3 months during the study period NOT_YET_RECRUITINGUse of Wearables for Identifying Factors Associated With Mild Cognitive Impairment and Early-Stage Alzheimer's Disease N/A · n=150 (ESTIMATED) · Est. completion: 2027-12 Sponsor: Getúlio Vargas University Hospital + Universidade Federal do Amazonas, Samsung Eletrônica da Amazônia Ltda Primary endpoints:
Sites: Getúlio Vargas University Hospital, Manaus, Brazil Inclusion: Inclusion criteria Age 65 years or older; Clinical suspicion of MCI, early AD Patients who are conscious, oriented, and able to respond to questionnaires; Ability and willingness to use wearable devic... | Exclusion: Exclusion criteria Unconfirmed diagnosis of MCI or early AD; Voluntary withdrawal at any stage of the study; Death during the research period; Inappropriate use or non-adherence to the use of wearable... |
| Regulatory | Already FDA-cleared since 2021, continuing to expand indications and clinical applications (Mar 2026) |
| Product Updates | Co-authored SaFER protocol publication by Stanford's Dr. Kaufman and Flosonics CMO provides structured bedside framework for IV fluid decisions (Mar 2026) link |
| Patents & IP | No specific patent data found |
| Publications | Venous waterfall and venous congestion. DOI Kenny JS, Moller PW · Intensive care medicine experimental · 2026 Mar 5 Venous congestion and the geometry of Guyton. DOI Kenny JS, Werner Moller P · Annals of intensive care · 2025 Oct 21 |
| Marketing | Received Vizient Innovative Technology Contract (Mar 2026) - nation's largest provider-driven healthcare performance improvement company link |
| Customer Traction | Mount Sinai Hospital deployment (Jun 2025), Sutter Health multi-site expansion (Jul 2025), VA/MHS/IHS contract through Lovell Government Services (Nov 2024) link |
| Team & Hiring | 65 total employees as of latest data, up from 30 employees previously reported (Jul 2024) indicating significant hiring link |
| Key Weakness | Limited to fluid management in sepsis/critical care - not directly competing in stroke monitoring space, different clinical application entirely |
| Vibrant Counter | Vibrant monitors upstream hemodynamic changes in carotid arteries for stroke prevention, while FloTrac focuses on downstream fluid responsiveness in critically ill patients - completely different vascular territories and clinical applications |
| ⚡ 90-Day Watch | Monitor for potential expansion beyond critical care into vascular monitoring applications or partnerships with stroke care providers |
| Latest News | Empatica received FDA 510(k) clearance for EmbraceMini sleep monitoring device (Jan 2026), marking further expansion of FDA-cleared tools. Launched new CE MDR certified Parkinson's monitoring solution combining EmbraceMini with PKG algorithms for clinical use in Europe/UK (Jan 2026) link |
| Funding | Series B funding round completed (Nov 2022) led by Sanofi Ventures and RA Capital Management with Black Opal Ventures participation. Total raised $33.8M across 5 rounds. No new funding rounds reported in past 90 days link |
| Clinical Trials | Partnering with Allucent on government-funded PROJECT REMOTE COVID-19 vaccine trial (4,000 participants) using EmbracePlus wearables. Active in multiple therapeutic areas including neurology, endocrinology, respiratory, mental health, and cardiology trials link |
| Regulatory | FDA 510(k) clearance for EmbraceMini sleep monitoring (Jan 2026). FDA PCCP authorization for pulse oximetry algorithm (Jun 2025) - first ever PCCP for pulse oximetry device. CE MDR certification for Parkinson's monitoring solution (Jan 2026). Six total FDA clearances achieved link |
| Product Updates | Launched EmbraceMini (Jun 2025) - world's smallest actigraphy wearable (12mm thick, 14mm wide). Integrated PKG Health's 38 motor assessment algorithms for Parkinson's monitoring. Multi-device support for simultaneous data capture. EmbraceMini FDA clearance expected late 2025 - achieved Jan 2026 link |
| Patents & IP | No data found |
| Publications | Influence of personality, cognition, and hearing loss on the association of real-world listening conditions with self-reported listening effort and heart rate. DOI Micula A, Flensborg-Madsen T, Christensen JH · Hearing research · 2026 Mar 24 From stress to success: using physiological data to predict cardiopulmonary resuscitation simulation performance. DOI Queirolo L, Mormando G, Vittadello A et al. · Frontiers in psychology · 2026 Towards real-time sleep stage classification: A deep learning approach leveraging PPG and ECG. DOI Djanian S, Nielsen TD, Nielsen SH et al. · Physiological measurement · 2026 Mar 18 Why nonlinear models matter: unified analysis of cognitive load, stress, and exercise using wearable physiological signals. DOI Shahriar KA · Physiological measurement · 2026 Mar 23 The Use and Utility of Wearable Devices for Tracking Sleep and Activity in Inpatient Mental Health Settings: Protocol for a Rapid Review. DOI Strudwick G, Shin HD, Kassam I et al. · JMIR research protocols · 2026 Mar 10 |
| Marketing | Announced transition from Embrace2 to EpiMonitor branding for epilepsy monitoring. Launched comprehensive Parkinson's monitoring solution in Europe combining EmbraceMini with PKG algorithms. Active conference presence at MDS Congress, AES Annual Meeting, and SCOPE Summit (2025) link |
| Customer Traction | Deployed across 150+ hospitals and clinical sites globally. Technology used by thousands of institutional partners. Major pharma partnerships for clinical trials. Government contracts including BARDA partnership for PROJECT REMOTE study link |
| Team & Hiring | Matteo Lai (CEO), Simone Tognetti (CTO), Dr. Marisa Cruz (CMO), Rosalind Picard (Chief Scientist). Company has 129 total employees. Recent acquisition of PKG Health team expands movement disorder expertise link |
| Key Weakness | Focus remains primarily on research/clinical trials rather than direct patient care market. EmbraceMini still awaiting FDA clearance for broader clinical applications beyond sleep monitoring. Limited direct competition in stroke monitoring space compared to epilepsy/Parkinson's focus |
| Vibrant Counter | While Empatica has strong clinical validation and FDA clearances, their EDA+PPG wrist-based approach cannot directly monitor carotid blood flow like Vibrant's bilateral ultrasound patches. Empatica measures downstream physiological responses rather than the hemodynamic source of stroke. Their 24/7 monitoring creates similar value proposition but lacks the specific stroke prediction capability of direct carotid monitoring. |
| ⚡ 90-Day Watch | Monitor EmbraceMini full commercial launch and adoption rates. Track Parkinson's monitoring solution market penetration in Europe. Watch for potential expansion into cardiovascular monitoring applications given their pulse oximetry and cardiac biomarker capabilities. Key signal: any announcements regarding stroke or cardiovascular disease research partnerships |
| Latest News | MindRhythm submitted de novo FDA application for Harmony device (Oct 2025) link |
| Funding | Total funding raised $10.4M according to PitchBook vs. $5M seed round from August 2021 according to Tracxn. Discrepancy in reported amounts - last major round $5M seed led by DCVC, Aestus Capital in August 2021 |
| Clinical Trials | N/A · n=150 (ESTIMATED) · Est. completion: 2027-03-30 Sponsor: MindRhythm, Inc. Primary endpoints:
Sites: MindRhythm Incorporated, Cupertino, United States · MindRhythm Incorporated, Cupertino, United States Inclusion: Inclusion Criteria: An individual who has been diagnosed with or suspected to have a concussion or mTBI.
\- | Exclusion: Exclusion Criteria: open wounds on the head. Pregnant women due to unexpected risks. Subjects under the age of 4.
\- RECRUITINGSeizure Prediction Using Wearable EEG N/A · n=150 (ESTIMATED) · Est. completion: 2026-03 Sponsor: Dux Healthcare Inc. + rs-ness Primary endpoints:
Sites: Rambam Medical Center, Haifa, Israel · Sheba Medical Center, Ramat Gan, Israel Inclusion: Inclusion Criteria:
* Age: 12 years and older.
* Diagnosis of epilepsy confirmed by EEG, with at least one seizure captured during EEG monitoring by a trained expert.
* Seizure frequency ranging from... | Exclusion: Exclusion Criteria:
* Scalp conditions or physical characteristics preventing proper device fit.
* Any technical or logistical challenges that would prevent reliable EEG data collection or compliance... |
| Regulatory | De novo FDA submission October 2025; FDA Breakthrough Device designation granted 2023; Company anticipating broad adoption following FDA clearance |
| Product Updates | Device design finalized based on real-world EMS feedback, improved ergonomics and optimized performance with robust platform tailored to primary users |
| Patents & IP | No data found |
| Publications | EPISODE pilot phase results published in Academic Emergency Medicine (May 2024); JAMA Network Open publication on concussion HeadPulse measurement (Aug 2023) |
| Marketing | Harmony recognized as finalist in EMS World Expo Innovation Awards as 'hottest new product in the industry' link |
| Customer Traction | EPISODE study included 6 states, 17 hospitals, and 14 EMS facilities - largest study of prehospital stroke identification device |
| Team & Hiring | 11-50 employees as of current data, including Beth Johnson (Director Commercial Development), Lisa Distenfield (Director Clinical Affairs), Ricardo Cortejoso (Product Development Manager) |
| Key Weakness | Uses accelerometer technology to detect brain 'pulse' pattern rather than direct physiological measurement - downstream detection approach similar to other competitors |
| Vibrant Counter | Vibrant's bilateral carotid ultrasound provides direct hemodynamic monitoring at the source of stroke causation, while MindRhythm's accelerometer detects downstream cranial pulsation effects - Vibrant measures the cause, MindRhythm measures consequences |
| ⚡ 90-Day Watch | Monitor FDA de novo review timeline and decision, any additional funding announcements, commercial partnerships post-clearance, and competitive response to Ceribell's competing EEG-based LVO monitoring breakthrough designation |
| Latest News | Integration with Huemn wellness clinic in Houston for brain health assessment during World Alzheimer's Month (Sep 2025) link |
| Funding | Last funding round was $57.2K grant in December 2018. Total raised $8.6M lifetime. No new funding activity found since 2018. link |
| Clinical Trials | No active stroke-specific clinical trials found. Selected for StartUp Health's Alzheimer's Moonshot Community (May 2024), but focus remains on neurodegenerative diseases rather than acute stroke detection. |
| Regulatory | FDA clearance obtained November 2022 for single-channel EEG brain monitoring platform. CE Mark achieved earlier but specific date not found in search results. |
| Product Updates | No significant product development updates found in 2024-2026 timeframe. Company continues validation in clinical trials for pharmaceutical screening applications. |
| Patents & IP | Filed 14 patents total according to CB Insights data (Sep 2025). Company's patented product currently being validated in clinical trials and used by pharmaceutical companies for patient screening. link |
| Publications | Neurosteer announced publication in Frontiers in Neurology detailing revolutionary approach to Parkinson's disease detection using pocket-sized hdrEEG system and 15-minute auditory assessment. link |
| Marketing | Partnership with Huemn wellness clinic in Houston integrating hdrEEG technology with hyperbaric oxygen therapy for brain health assessment (Sep 2025). link |
| Customer Traction | Working with Western Galilee Hospital for several years. Used by pharmaceutical companies for patient screening and efficacy testing of new drugs. Recently integrated into Huemn clinic in Houston. |
| Team & Hiring | Small team of 12 employees with no significant hiring signals found. Company appears to be maintaining minimal staffing levels. |
| Key Weakness | Focused on chronic neurological conditions (Parkinson's, Alzheimer's) rather than acute stroke detection. Limited to single-channel EEG monitoring which cannot detect hemodynamic changes that precede stroke symptoms. |
| Vibrant Counter | Neurosteer detects downstream electrical brain changes after neuronal damage occurs, while Vibrant monitors upstream carotid hemodynamic changes before any brain cell dies. Their EEG approach misses the therapeutic window for stroke prevention. |
| ⚡ 90-Day Watch | Monitor for any new funding announcements or clinical trial initiations. Track expansion of Huemn partnership model to other wellness clinics. Watch for potential pivot toward stroke applications given stagnant growth in neurodegenerative space. |