NeuroTech Newsletter #4
May 01, 2025
Executive Summary
Welcome to the 4th Edition of the Neurotech Newsletter.
While economic uncertainty continues to be the topic of conversation, the Neurotech momentum builds with exciting news across hiring, regulatory, clinical and funding in implantables, wearables , diagnostics and more. The newsletter also reached over 100 subscribers too, showing the appetite for regular updates in the forever expanding Neurotech community. If you have any suggestions or ideas feel free to message me at chay@cartersciences.com
Funding News
Spark Biomedical has closed their $15M Series A round
Spark Biomedical Inc2025-04-30
Spark Biomedical secured $15 million in a Series A led by WAVE Ventures with support from Pathway to Cures to advance its wearable, non‐invasive neurostimulation platform targeting vagus and trigeminal nerves. The funding will accelerate development of bioelectronic treatments for neurological health, hemostasis, and women’s health, positioning the company to deliver drug‐free alternatives to unmet clinical needs.
BCI Market Funding Update
GlobeNewswire2025-04-25
The global BCI market is projected to expand from USD 2.62 billion in 2024 to USD 12.40 billion by 2034 at a double-digit CAGR, driven by R&D investments, cost-effective non-invasive devices, clinical trials, and strong government support. Recent key financings include Precision Neuroscience’s $155 million, INBRAIN Neuroelectronics’ $50 million Series B, Neurable’s $13 million, and Tether’s $200 million stake in Blackrock Neurotech, underscoring a robust funding landscape.
Neuralink Eyes $500M Funding Round
Reuters2025-04-23
Elon Musk’s Neuralink is in preliminary talks to raise approximately $500 million at an $8.5 billion pre-money valuation to scale its brain implant for spinal cord injury rehabilitation and future neuroaugmentation applications. This round follows a prior $280 million raise led by Founders Fund and coincides with FDA-approved clinical trials and renewed investor interest in both medical and consumer neural interfaces.
Summary
The recent influx of capital into both non-invasive neurostimulation and brain-computer interface ventures reflects growing investor confidence in neurotechnology’s commercial potential. Series A and strategic rounds for Spark Biomedical and Neuralink, alongside multihundred-million-dollar deals in the BCI sector, will accelerate device development, clinical validation, and go-to-market strategies. As funding sources diversify—from venture capital to philanthropy—collaboration with regulators is likely to intensify, expediting approvals and driving broader adoption in healthcare and adjacent markets.
Investors are increasingly favoring platforms that combine AI-driven interfaces with drug-free treatment modalities, signifying a shift toward minimally invasive and personalized neurotherapies. Rising philanthropic and corporate backing, coupled with smoother regulatory pathways, points to a trend of modular, scalable neurotechnology solutions that address both medical conditions and consumer wellness applications.
FDA News
Ceribell’s point-of-care EEG system has achieved FedRAMP® High authorization
Ceribell2025-04-30
Ceribell’s AI-powered point-of-care EEG system has secured FedRAMP® High authorization, allowing deployment across federal healthcare networks, including VA hospitals. This elite cybersecurity clearance affirms the platform’s data protection standards and paves the way for broader adoption in diagnosing non-convulsive seizures among veterans and high-risk patients.
ClearPoint Prism 1.5T FDA Submission
ACCESS Newswire2025-04-28
ClearPoint Neuro and Clinical Laserthermia Systems have filed a 510(k) application to expand the ClearPoint Prism Neuro Laser Therapy System’s indication to 1.5 T MRI guidance. Pending anticipated clearance in H2 2025, this submission targets over half of the U.S. neuro LITT market currently unaddressed under 3.0 T restrictions.
FDA Grants Epiminder EEG Monitor Authorization
NeurologyLive2025-04-23
The FDA has issued De Novo authorization for Epiminder’s Minder, the first implantable continuous EEG monitor approved for drug-resistant epilepsy. Supported by the UMPIRE study, this device offers ultra-long-term seizure burden quantification, informing medication adjustments and surgical candidacy through high-fidelity data captured over multi-year periods.
Holberg EEG has received FDA approval for their software, autoSCORE 2.0
Holberg EEG AS2025-04-17
Holberg EEG’s autoSCORE 2.0 software suite has gained FDA approval, enabling automated analysis of long-term and ambulatory EEG recordings. This clearance, to be distributed via Natus Neuro, aims to accelerate diagnostic workflows and enhance clinical decision-making through AI-driven scoring and streamlined interpretation.
Terumo Neuro FDA Approval
NeuroNews International2025-04-16
Terumo Neuro’s dual-layer micromesh carotid stent system has received FDA Premarket Approval for treating carotid artery stenosis in patients at elevated risk after endarterectomy. Designed for vessel diameters of 3.5 mm to 9 mm, this first-in-class device offers a clinically validated option for both de novo and restenotic lesions at the carotid bifurcation.
Summary
These developments collectively signal a broadening of regulatory pathways beyond traditional device clearances to encompass cybersecurity and software authorizations, 510(k) expansions and De Novo pathways. The FedRAMP High milestone demonstrates the rising importance of cloud security in medical devices, while implantable and AI-driven EEG technologies reflect a shift toward continuous monitoring and data-based clinical decision support. Expansion of LITT MRI guidance and advanced carotid stent approvals will likely accelerate procedural adoption and competitive positioning across neurointerventional and neuromonitoring markets.
The current regulatory landscape for Neurotechnology is characterized by diversification of approval routes, increased focus on cybersecurity credentials, and emphasis on software-as-a-medical-device. Manufacturers are pursuing modular submissions to extend indications, leveraging De Novo to introduce novel implantable devices, and integrating AI analytics to enhance clinical utility. This trend underscores a maturing regulatory environment that adapts to digital innovations while maintaining rigorous safety and efficacy standards.
Clinical News
Alto Neuroscience Uncovers Molecular Mechanisms Behind ML-Discovered Biomarker for ALTO-300
Alto Neuroscience2025-05-01
Alto Neuroscience reports the mechanistic validation of an EEG biomarker discovered by a data-agnostic machine learning pipeline that predicts adjunctive response to ALTO-300 (agomelatine) in major depressive disorder. In preclinical and human studies, modulation of 5-HT2C activity and dopamine levels produced EEG signatures consistent with the biomarker profile, reinforcing its use for patient stratification in the ongoing Phase 2b trial.
NeuroSigma Clinical Trial for ADHD Treatment in FAS Children
GlobeNewswire2025-04-30
NeuroSigma has initiated a Phase I feasibility study of its Monarch external trigeminal nerve stimulation system in 8- to 12-year-olds with fetal alcohol syndrome and ADHD-like symptoms. Funded by NIAAA, the four-week trial will assess safety, tolerability and preliminary efficacy through parent-reported symptom diaries, laying the groundwork for a subsequent randomized crossover study.
Positive Tinnitus Treatment Data Published
Nature Communications Medicine2025-04-28
A real-world analysis of 220 U.S. patients treated with the FDA-cleared Lenire bimodal neuromodulation device shows 78% achieved a clinically meaningful reduction in tinnitus after six weeks and 91.5% improved at 12 weeks. These outcomes closely mirror pivotal trial data, reinforcing Lenire’s at-home, twice-daily regimen of synchronized audio and tongue stimulation under clinical oversight.
Perfuze Announces Significant Milestones
NeuroNews International2025-04-25
Perfuze has completed ahead of schedule enrollment of over 180 patients in its pivotal IDE trial evaluating the Millipede 088 super-bore aspiration catheter for rapid clot removal in large vessel occlusion strokes. Data from this multicenter safety and efficacy study will support an expanded FDA submission, while new sales leadership positions the company for U.S. commercialization.
tDCS at Home Improves Sleep in Depression
Scientific Research Publishing Inc2025-04-25
A retrospective analysis of over 20,000 users of the Flow FL-100 home tDCS device found that among 6,229 individuals with baseline insomnia and depression, 63.2% achieved insomnia remission after ten weeks of daily sessions. A clear dose-response relationship emerged, suggesting at-home tDCS may offer rapid relief for sleep disturbances linked to depressive severity.
Hyperfine Begins Neurological MRI Study
NeuroNews International2025-04-17
Hyperfine has enrolled the first patients in its NEURO PMR prospective observational study comparing AI-powered portable ultra-low-field MRI to conventional high-field scanners in two private neurology practices. Targeting 100 participants by year’s end, the trial will evaluate diagnostic concordance, clinical utility and patient experience to validate in-office neuroimaging accessibility.
Summary
Taken together, these developments underscore a shift toward precision and accessibility in neurotechnology. Biomarker-driven patient selection in depression and home-based neuromodulation for insomnia exemplify tailored interventions, while real-world data on tinnitus treatment and pivotal stroke device trials reinforce clinical confidence in novel devices. Simultaneously, AI-powered portable MRI and targeted eTNS for underserved ADHD populations expand diagnostic and therapeutic reach beyond traditional settings.
The convergence of data-driven biomarkers, decentralized treatment delivery and adaptable neuro-imaging platforms marks an emerging trend toward personalized, scalable neurotechnology solutions. Future research is likely to build on machine-learning biomarkers, real-world evidence and minimally invasive devices to further democratize neurological care.
Leadership Appointments
Precision Neuroscience announces two significant additions to senior leadership team
Precision Neuroscience2025-05-01
Precision Neuroscience has strengthened its commercial and governance capabilities with the appointments of John Woock as Chief Business Officer and Konstantinos Alataris, PhD, to its Board of Directors. Woock brings a proven track record from Axonics, where he led clinical trials and scaled revenue to $450 million, and will now drive Precision’s go-to-market strategy for its FDA-cleared cortical electrode array. Dr. Alataris, founder and former CEO of Nevro and past chair of Iota Biosciences’ scientific advisory board, will guide strategic oversight as Precision advances its AI-enabled neurotherapies toward commercialization.
Cyril Eleftheriou Joins Subsense as Neurotech Lead
Subsense Inc2025-05-01
Subsense has appointed Cyril Eleftheriou as Neurotechnology Lead to head R&D for its non-surgical, nanoparticle-based brain–computer interface. Eleftheriou joins from Novartis, where he led neuro-electronic interfacing and retinal degeneration therapies, and brings international research experience from Weill Cornell’s Burke Neurological Institute and Italy’s Istituto Italiano di Tecnologia. His interdisciplinary expertise will be instrumental in advancing Subsense’s implant-free BCI platform.
Lisa Fosdick promoted to Chief Clinical & Strategy Officer at Sinaptica Therapeutics
Sinaptica Therapeutics2025-04-30
Sinaptica Therapeutics has elevated Lisa Fosdick to Chief Clinical & Strategy Officer, expanding her remit to lead design and execution of seamless adaptive trials for the SinaptiStim® Precision Neuromodulation System in Alzheimer’s disease across the U.S. and EU. Fosdick will also oversee clinical operations strategy and collaborate with scientific founders on pipeline expansion into new neurological and psychiatric indications.
Xylo Bio Announces Samantha Tabone as Director of Business Development
Xylo Therapeutics2025-04-29
Xylo Bio has welcomed Samantha Tabone as Director of Business Development to accelerate partnerships and commercial strategy for its targeted neurotherapeutics platform. Tabone, formerly of XEIA Venture Partners, brings deep experience in CNS drug development and venture financing, aligning with Xylo’s mission to scale innovative mental health and neurological treatments.
iota Biosciences announces two senior leadership changes
iota Biosciences2025-04-28
iota Biosciences has appointed Michael Woods, MD, as General Manager of Urological Therapies and Gil Mandelbaum, PhD, as General Manager of Neurological Therapies. Woods and Mandelbaum will lead commercialization and clinical development of iota’s implantable devices for urological and neurological disorders, reinforcing focused management as the company advances its pipeline.
Nia Therapeutics welcomes Milton M. Morris to Board of Directors
Nia Therapeutics2025-04-24
Nia Therapeutics has added Milton M. Morris, PhD, to its Board of Directors as an Independent Director. Morris, former CEO of Neuspera Medical and ex-VP of R&D at Cyberonics, brings over 25 years of medtech leadership, FDA regulatory expertise, and commercial strategy to support the advancement of Nia’s Smart Neurostimulation System through late-stage clinical development and market entry.
Summary
These leadership changes mark a critical shift in neurotechnology companies moving from research into commercialization and strategic expansion. The infusion of executives with strong commercial track records, clinical trial expertise, and global R&D leadership will accelerate regulatory progress, forge new partnerships, and enhance go-to-market capabilities. As each company scales its operational infrastructure and sharpens strategic focus, competition for funding and talent will intensify, driving innovation across BCIs, neuromodulation, and non-surgical interfaces.
Across the appointments, a clear trend emerges toward blending deep technical expertise with seasoned commercial and clinical leadership. Companies are elevating C-suite roles and board compositions to bolster strategic governance, streamline clinical development, and scale revenue operations. This convergence of scientific rigor and business acumen signals the neurotechnology sector’s maturation and readiness for broader market adoption.
Closing Thoughts
The Neurotechnology industry is stepping into a new maturity phase defined by intersecting surges in capital, regulatory innovation, and clinical validation. Series-A and multi-hundred-million-dollar raises spanning non-invasive neuromodulation to implantable BCIs reflect a broad investor conviction in AI-enhanced, drug-free therapies. Simultaneously, FDA clearances—from FedRAMP High cybersecurity authorizations to De Novo implantable EEG devices—signal an evolving regulatory framework that embraces software-as-a-medical-device and continuous monitoring.
A dynamic interplay between funding, regulation, clinical breakthroughs, and leadership appointments is accelerating time-to-market and shaping competitive landscapes. Large financings are directly underwriting pivotal trials for stroke aspiration catheters, depression biomarkers and at-home neuromodulation studies, while streamlined 510(k) expansions and De Novo pathways are lowering approval barriers for cutting-edge devices. Concurrently, C-suite and board additions with proven commercialization, trial design and regulatory expertise are binding these domains, ensuring that scientific promise translates into tangible market impact. Looking forward, companies should institutionalize regulatory foresight by integrating cybersecurity, AI validation and modular submission strategies from day one. Allocating resources to adaptive, decentralized trial models and robust real-world evidence collection will be essential for securing reimbursement and sustaining iterative innovation. Strategic alliances with federal healthcare networks, payers and academic research consortia can both expedite patient access and amplify data-driven outcomes. We forecast that home-based neurotherapeutics and AI-driven diagnostics will command an outsized share of funding and fast-track approvals over the next five years. With unparalleled funding momentum, a flexible regulatory environment and a growing corpus of clinical evidence, the neurotechnology sector stands at an inflection point. Companies that align strategic investments, regulatory planning, and commercialization talent will lead the charge in delivering scalable, personalized neural solutions. As this transformative cycle accelerates, the opportunity is clear: deploy these convergent insights to redefine neurological care and capture the expanding $12 billion-plus BCI and neuromodulation markets ahead.
