NeuroTech Newsletter #8

Published on June 27, 2025

Executive Summary

Welcome to the 8th edition of the Carter Sciences Neurotech Newsletter!

From Reid Hoffman–backed, AI-driven anxiety headsets to ultracompact Alzheimer's PET scanners, a flood of capital is empowering non-invasive, consumer-grade neurotechnologies. Regulators have responded in kind with FDA and global clearances for surgical robots, fMRI mapping software and at-home neuromodulation systems, while clinical milestones—from silent speech decoders to precision rTMS protocols and closed-loop vagal therapies—underscore the field's therapeutic promise. Complemented by strategic leadership appointments, M&A deals and educational grants, this issue unpacks how the convergence of funding, regulation, science and talent is driving a scalable, integrated neurotech ecosystem.

Check out the highlights below and as always send through any recommendations or feedback to chay@cartersciences.com

Funding News

Reid Hoffman Backs $500 Brain Device

GuruFocus | 2025-06-24

LinkedIn co-founder Reid Hoffman has led a $12 million round for Sanmai Technologies, a stealth startup developing a non-invasive, AI-powered ultrasound headset for treating mental health conditions and enhancing cognition at home. The sub-$500 device aims to target specific brain regions associated with anxiety, depression, or cognitive decline, offering an alternative to pharmaceutical solutions and invasive brain chips. Hoffman joins the board, as Sanmai advances clinical trials and works toward FDA discussions, leveraging AI to guide therapy customization and overcome technical challenges like skull distortion and dosage personalization.

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EMOTIV MW20 launches on Kickstarter

EMOTIV | 2025-06-20

EMOTIV has launched the MW20, EEG-enabled noise-cancelling earphones on Kickstarter, positioning the device for daily use to give consumers real-time insights into cognitive states such as focus, stress, and fatigue. With nearly 20 years of expertise in non-invasive neurotechnology research, the company is now targeting everyday life applications and highlighting the importance of neuroscience tools for broader human-AI synergy. The MW20 aims to empower users to better understand and manage their mental well-being and productivity.

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Neurable announces strategic investment from Ascendo Venture Capital

Neurable | 2025-06-18

Neurable has secured a strategic investment from Ascendo Venture Capital to further its mission of democratizing brain-computer interface (BCI) technology. With a focus on inclusivity and disruptive innovation, this partnership is set to fuel expansion of Neurable's wearable neurotechnology ecosystem, including the MW75 Neuro headphones, and drive progress toward more accessible and powerful BCI tools for a wider population.

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Ultracompact PET Scanner Funding

Radiology Business | 2025-06-11

Positrigo, a Swiss startup specializing in brain imaging, has raised $8.5 million in a round led by HealthCap and Navivo to commercialize its FDA-cleared NeuroLF ultracompact brain PET scanner. The system, integrated into a dental-style chair, simplifies access to PET imaging for Alzheimer's diagnosis and research. The investment will support expansion in the U.S. and Europe, aiming to meet rising demand as Alzheimer's prevalence grows, and is complemented by new industry partnerships to deploy the technology in dedicated imaging centers.

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Mapping Brain Targets for Inflammation

PRNewswire | 2025-05-27

Corundum Neuroscience has awarded a research grant to Professor Asya Rolls at Tel Aviv University to map brain regions involved in immune response during inflammation. Using advanced virology and brain imaging, the project will identify neuromodulation pathways for autoimmune and inflammatory disorders, potentially shedding light on new, non-invasive treatments for conditions such as Crohn's disease, multiple sclerosis, and type 1 diabetes. The findings may lay the groundwork for novel therapeutic strategies that harness the brain's modulation of immunity.

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Industry Analysis

The latest funding activity demonstrates robust investor confidence in non-invasive and consumer-oriented neurotechnologies, with emphasis on mental health, brain-computer interfaces, and accessible diagnostic tools. High-profile backers like Reid Hoffman propel visibility and legitimacy for emerging mental health solutions that challenge traditional pharmacological and surgical approaches. The trend toward integrating AI into neurotech devices and progress in FDA-clearance and commercialization efforts highlight the blurring line between clinical and everyday applications. Importantly, venture capital is increasingly targeting inclusivity and broad deployment, as evidenced by investments in consumer neurotech, strategic partnerships, and international commercialization strategies, particularly in the context of mounting neurological health challenges such as Alzheimer's disease.

Trend Conclusion

These developments signal accelerating convergence of neuroscience, artificial intelligence, and user-focused design in neurotechnology. The focus on non-invasive, wearable, and affordable devices—connected with AI for personalization—reflects a shift from research and clinical use to widespread consumer adoption. At the same time, investment in brain mapping for immune disorders suggests continued expansion of neurotech applications. Collectively, the industry is moving toward greater accessibility, early diagnosis, and integrated wellbeing, with rapid innovation poised to reshape both personal and population health paradigms.

Regulatory News

Reshape Patent for Diabetes Neuromodulation

GlobeNewswire | 2025-06-25

ReShape Lifesciences has been granted a significant international patent by the Australian Patent Office for its Diabetes Neuromodulation system—a device utilizing multi-site vagus nerve neuromodulation to achieve improved glycemic control for patients with Type 2 diabetes. The technology combines proprietary vagus nerve block and stimulation with intelligent, responsive therapy based on real-time glucose monitoring. Preclinical results have shown efficacy in animal models, strengthening ReShape's intellectual property position and promising a more individualized, minimally invasive alternative to traditional diabetes management, potentially reducing medication use and overall disease burden.

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Science Submits BCI for CE Mark

MassDevice | 2025-06-23

Science Corporation, a U.S.-based developer of brain-computer interfaces, submitted its Prima retinal implant for CE Mark approval in Europe, aiming to restore functional vision in patients with retinitis pigmentosa and dry age-related macular degeneration. Developed with Pixium Vision, the Prima system leverages photovoltaic technology to restore central vision while maintaining peripheral natural vision, with European trials yielding encouraging results. Science is also in discussions with the FDA regarding transitional pathways for U.S. market access and is ramping up infrastructure for potential commercialization.

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FDA Clears Sora Cirrus Mapping

EINPresswire | 2025-06-20

The FDA has cleared Sora Neuroscience's Cirrus brain mapping software, which leverages resting-state fMRI to generate detailed cortical network maps for neurosurgical planning. The system is designed for integration with existing surgical platforms and facilitates advanced mapping for diverse patient populations, including children. This clearance supports more precise surgical outcomes by helping neurosurgeons preserve functional areas of the brain during challenging procedures.

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Brain Navi Announces U.S. FDA Approval for NaoTrac Robot

Surgical Robotics Technology | 2025-06-18

Brain Navi Biotechnology has received FDA 510(k) clearance for the NaoTrac stereotaxic guiding surgical robot, enabling its use in U.S. operating rooms. NaoTrac provides precise, AI-powered autonomous navigation for neurosurgical procedures such as biopsies, tumor ablations, endoscopic interventions, and deep brain stimulation. The system incorporates frameless, non-contact patient registration and advanced robotic automation to enhance surgeon accuracy and efficiency.

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FDA Approves iSNM System for UUI

PRNewswire | 2025-06-18

Neuspera Medical's integrated sacral neuromodulation (iSNM) system has received FDA approval for treating urinary urge incontinence. The iSNM features a miniaturized, wirelessly rechargeable neurostimulator implanted near the sacral nerve, activated externally to deliver continuous therapy without the drawbacks of implanted batteries. Clinical trial results demonstrate robust efficacy and significant quality-of-life improvements for patients. The approval introduces a less invasive, patient-friendly treatment alternative for UUI.

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TGA Approves Home Brain Stimulation

soomamedical.com | 2025-06-16

Sooma Medical has secured Therapeutic Goods Administration (TGA) approval in Australia for its next-generation transcranial Direct Current Stimulation (tDCS) device, extending its offering to home-based, clinician-monitored neurostimulation for major depressive disorder. The system incorporates integrated clinical protocols, remote digital monitoring, and a patient-centric, streamlined interface for self-administration at home, enhancing access to care, particularly for underserved or remote populations.

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Regulatory Impact Analysis

The recent round of FDA approvals and international regulatory milestones signals robust momentum in neurotechnology innovation and adoption. The clearance of novel neuromodulation systems—such as ReShape Lifesciences' diabetes device and Neuspera Medical's iSNM—opens possibilities for less invasive, patient-customized therapies that can replace or significantly reduce reliance on conventional pharmacologic approaches. Precision mapping solutions and advanced surgical robotics, like those from Sora Neuroscience and Brain Navi, promise to improve safety, accuracy, and clinical outcomes in neurosurgical interventions. Meanwhile, the validation and regulatory greenlighting of at-home stimulation systems abroad—such as Sooma's tDCS device—demonstrate a shift toward decentralized, telehealth-supported models of neurotechnology delivery. The international nature of these developments, including cross-continental approvals and market preparations, highlights the increasing globalization and scalability of neurotechnology platforms.

Regulatory Trend Conclusion

These articles collectively underscore a growing trend of regulatory bodies prioritizing innovative, patient-centric neurotechnology—especially minimally invasive, smart stimulation platforms and digital therapeutics. There's a notable acceleration in software and device clearances targeting precision, remote monitoring, and personalized medicine. As regulatory authorities continue to show openness toward advancing neurotechnology with an emphasis on safety and outcome-driven validation, the industry is poised for broader adoption, expedited global market access, and an expanding array of indications for neural interface and stimulation technologies.

Clinical News

Breakthrough in Silent Speech: Araya BCI Team Unveils Non-Invasive EEG/EMG Decoder for Restoring Communication

Araya | 2025-06-20

This preclinical innovation from the Araya BCI team describes a non-invasive EEG/EMG-based system capable of decoding silent speech, presenting a significant alternative to invasive BCIs for patients who have lost the ability to speak. The model leverages large, healthy control datasets and rapid patient-specific tuning, dramatically improving word recognition in a locked-in patient from 13.2% to 54.5% accuracy. The technology is device-agnostic and enables swift calibration for new users, with ongoing efforts toward scaled patient trials and real-world deployment enhancements involving large language models.

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Alzheimer's rTMS Review Elucidates Multimodal Action

Business Wire | 2025-06-18

A comprehensive review published in Alzheimer's & Dementia synthesizes robust evidence that repetitive transcranial magnetic stimulation (rTMS) exerts multimodal therapeutic effects in Alzheimer's disease, spanning molecular to network levels. The review elucidates how precision neuronavigated rTMS modulates neuroinflammation, synaptic function, and network connectivity to enhance neuroplasticity, restore cognitive performance, and slow disease progression. The body of evidence supports integrating rTMS into personalized, proactive precision medicine frameworks for Alzheimer's, emphasizing targeted modulation of the Default Mode Network.

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Instantaneous Voice-Synthesis Neuroprosthesis

Nature | 2025-06-12

In this single-patient clinical study, researchers developed an intracortical brain-to-voice neuroprosthesis that synthesizes expressive, real-time speech from neural activity in an individual with ALS and severe dysarthria. By decoding activity from 256 microelectrodes implanted in the ventral precentral gyrus, the system generated fluent speech—including intonation and melodic features—without using ground-truth speech for training. The technology demonstrates substantial progress toward restoring naturalistic communication for individuals with paralysis.

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rTMS Lowers Depression Treatment Costs

Becaris Publishing | 2025-06-10

This retrospective observational study, utilizing Medicare and commercial claims data from 2021–2023, finds that rTMS treatment for patients with treatment-resistant depression significantly reduces overall healthcare utilization and costs over 18 months. Treated patients experienced fewer hospital and emergency visits, with an average reduction in episode-of-care costs by $893 compared to those not receiving rTMS. The study strengthens the evidence for rTMS as both a clinically and economically advantageous intervention in real-world settings.

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Age-Specific Autism Biomarkers

Starlab | 2025-06-03

Starlab researchers employed innovative EEG analytics to identify delta–beta phase–amplitude coupling (PAC) as a potential biomarker for autism, with significant PAC elevations in autistic adults compared to controls, but not in children or adolescents. This neurophysiological signature correlates with the severity of restrictive behaviors and hyperactivity/impulsivity, highlighting PAC's promise as an age-specific biomarker and supporting the refinement of objective diagnostic tools in autism neurodevelopmental research.

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Closed-loop Vagus Nerve Stimulation Aids Recovery

Nature | 2025-05-21

In a double-blind randomized controlled trial, closed-loop vagus nerve stimulation paired with individualized physical therapy enhanced upper-limb recovery in patients with chronic cervical spinal cord injury. The miniaturized implant delivered stimulation in real time, activating with successful motor attempts, and was associated with measurable improvements in grip and hand function without cardiovascular side effects. The findings showcase the therapeutic potential of closed-loop neuromodulation for promoting neuroplasticity and functional gains in populations with longstanding disabilities.

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Clinical Impact Analysis

The recent advancements illustrate how neurotechnology is rapidly translating from highly technical innovations to tangible improvements in patient communication, functional recovery, and mental health care. Novel non-invasive and invasive brain-computer interfaces are offering new communication avenues for individuals with paralysis, while scalable, device-agnostic models like Araya's EEG/EMG decoder may accelerate patient access and clinical adoption. Neuromodulation techniques, especially rTMS and closed-loop vagus nerve stimulation, are demonstrating not only clinical efficacy in treatment-resistant populations but also measurable cost savings and meaningful improvements in quality of life and independence. The identification of reliable neurophysiological biomarkers, such as age-specific EEG markers for autism, is moving the field closer to objective, precision diagnostics and individualized intervention planning.

Research Trend Conclusion

A prevailing trend across these studies is the integration of advanced analytics and adaptive algorithms—whether in decoding neural activity for communication, refining neurostimulation protocols, or detecting biomarkers from large datasets. Precision and personalization, underpinned by scalable AI and real-world validation, are guiding the neurotechnology research agenda. Additionally, the convergence of economic, clinical, and technological benefits is catalyzing broader healthcare system adoption, setting the stage for neurotechnology to play a pivotal role in managing and treating complex neurological and neuropsychiatric conditions.

Commercial Collaborations and Launches

NeuroTech Course & Handbook Announcement

NeuroTech Course | 2025-06-25

NeuroTech Course, with backing from the U.S. NIH and the Bakken Medical Devices Center, has launched a freely available, expert-driven online curriculum and a new Handbook focused on translating and commercializing neurotechnology. This initiative lowers barriers for entrepreneurs and innovators, providing practical education to accelerate market entry and product adoption.

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Neurocomputation Workshop Empowers Neuroscience Startups

PRNewswire | 2025-06-25

Corundum Convergence Institute and the University of Tokyo's International Research Center for Neurointelligence have partnered to launch the inaugural Neuro-inspired Computation and Entrepreneurship Workshop. The program, combining a course and workshops, is designed to mentor scientists and early-stage entrepreneurs on startup fundamentals, product-market fit, intellectual property, and investment strategy—catalyzing the next wave of neurotech commercialization.

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NeuroOne offers the first FDA Cleared sEEG-RF System

NeuroOne | 2025-06-20

NeuroOne has launched OneRF®, the first FDA-cleared sEEG-RF system, for drug-resistant epilepsy. This product integrates bedside monitoring, mapping, and ablation capabilities into a single platform, promising less invasive, patient-focused care and setting a new standard for precision neuromodulation in clinical environments.

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Bioness Acquires Harmonic Bionics Assets

PRNewswire | 2025-06-18

Bioness Medical has acquired Harmonic Bionics, a company specializing in bilateral upper extremity exoskeletons for rehabilitation following stroke or brain injury. This acquisition strategically expands Bioness's product portfolio into upper limb rehabilitation, underlining its commitment to comprehensive neuro-rehabilitation solutions and market reach post-Accelmed Partners acquisition.

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Neurable Launches Research Grant Program

Neurable | 2025-06-17

Neurable has unveiled a research grant program offering discounted access to its brain-computer interface Research Kit, perpetual licenses, and technical support to researchers in neuroscience and related fields. This initiative is designed to democratize access to high-quality EEG data for academic studies and stimulate novel applications of BCI technology.

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Strive fatures on Apple's heathcare website unResearch ad Development section

Rune Labs | 2025-06-16

Rune Labs' StrivePD, an FDA-cleared system leveraging Apple Watch and HealthKit data for Parkinson's care, has been showcased on Apple's healthcare website. This spotlight enhances StrivePD's visibility and positions it as a leader in continuous, real-world motor symptom tracking for Parkinson's Disease, reinforcing the growing role of consumer wearables in clinical neurotechnology.

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Board Expansion & Deep Learning Launch

BrainScope | 2025-06-11

BrainScope has launched a next-generation deep learning EEG platform targeting enhanced diagnosis across concussion, stroke, and early Alzheimer's. The rollout is paired with a strategic board expansion, bringing experts in MedTech commercialization, investment, and scaling to guide rapid market and clinical expansion. This move both strengthens operational leadership and fortifies BrainScope's technology pipeline.

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2025 Ultrasonic Neuromodulation Devices

Macho Levante | 2025-06-01

The 2025 landscape for ultrasonic neuromodulation devices is marked by advances in non-invasive brain therapies using focused ultrasound, with leading firms and academic groups collaborating on system development and clinical translation. The market is projected for robust growth as regulatory milestones are achieved, opening therapeutic opportunities for a broad range of neurological and psychiatric conditions.

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Market Impact Analysis

The latest round of commercial collaborations and product launches demonstrates escalating competition and sophistication in neurotechnology. Notably, acquisitions such as Bioness's integration of Harmonic Bionics and leadership hires at Thynk and BrainScope highlight accelerating consolidation and a drive for operational excellence. New product launches—including NeuroOne's FDA-cleared sEEG-RF system and BrainScope's AI-enabled EEG platform—are setting higher clinical standards and broadening application scopes. The expansion of grant and educational programs (Neurable and NeuroTech Course) is democratizing access to state-of-the-art neurotech, likely increasing research output and accelerating translation from academia to industry. With consumer tech partnerships like StrivePD's collaboration with Apple, the lines between clinical and consumer neurotechnology are continuing to blur, creating new hybrid models for market access and patient engagement.

Commercial Trend Conclusion

Trends point toward a rapidly maturing market characterized by cross-sector collaboration, a focus on accessibility (through grants, education, and consumer health platforms), and increased investment in leadership and M&A for strategic scale-up. Companies are aggressively positioning themselves by pairing technology launches with organizational scale and strategic alliances that integrate diverse expertise. The non-invasive, user-friendly paradigm and ecosystem-building approach are emerging as dominant strategies for commercial success and market adoption across the neurotechnology landscape.

Leadership Appointments

Linda Ystueta joins Thynk Inc as COO

Thynk Inc | 2025-06-26

Thynk Inc has appointed Linda Ystueta as Chief Operating Officer, an executive move that signals the company's commitment to operational leadership as it grows in the neurotechnology sector. This leadership addition may help streamline commercial activities and strategic planning as Thynk scales up its business.

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Avivomed Appoints New CEO

PR Newswire | 2025-06-26

Avivomed, a clinical-stage medical device company, has named Dan Brounstein as Chief Executive Officer and Board Member, succeeding Steve Masson. Brounstein, who brings over three decades of medtech experience and previously served as Chief Strategy Officer at Saluda Medical, is recognized for leadership in neuromodulation, commercialization, clinical execution, and innovation. His appointment marks a significant step for Avivomed as it amplifies its efforts in neuromodulation therapies to address sleep disorders, leveraging his proven record in launching clinical technologies and driving successful studies.

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Tony Sangermano joins THYNK as new CEO

THYNK Inc | 2025-06-24

THYNK Inc has announced Tony Sangermano as its new Chief Executive Officer. While minimal public detail is provided in the announcement, Sangermano's appointment signals a leadership refresh for the neurotechnology innovator and suggests renewed strategic focus as the company forges ahead in its mission.

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Antonio Manuel Lozano Ortego joins Ruten as Senior Scientific Consultant on Neuroengineering & AI

Ruten Inc | 2025-06-19

Ruten Inc welcomes Dr. Antonio Manuel Lozano Ortega as Senior Scientific Consultant on Neuroengineering & AI. A specialist in translational neural interfaces and neuroprostheses, Dr. Ortega will advise R&D on machine learning, computer vision, behavioral analysis, and neural decoding, while advancing visual neuroprosthesis research. His appointment is expected to deepen Ruten's scientific capabilities and strengthen its operations in both the US and Japan.

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Tulavi Therapeutics Appoints Raymond W. Cohen as Vice Chairman of its Board of Directors

Tulavi | 2025-06-18

Tulavi Therapeutics has named Raymond W. Cohen as Vice Chairman of its Board of Directors at a pivotal stage for the company's growth. Cohen's distinguished history as a medtech executive includes leading Axonics through public listing and sale, as well as significant roles in the successful scaling of medical device companies. His expertise in hydrogels, neurology, and commercialization is expected to accelerate Tulavi's Adaptive Hydrogel Technology strategy as the company expands its reach in peripheral nerve surgery.

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Dr. Rice Joins Scientific Advisory Board

Evren Technologies | 2025-06-17

Evren Technologies, a developer of non-invasive neuromodulation solutions for mental health, has appointed Dr. Laura Rice to its Scientific Advisory Board. Dr. Rice is CEO of LR Consulting Group and a former FDA regulatory lead, bringing comprehensive experience in neuroscience, translational device research, and regulatory strategy. Her expertise is set to support Evren's commitment to evidence-based, accessible therapies as the company pursues regulatory milestones for its PTSD-focused devices.

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Trent Campbell joins Boston Scientific as VP of Marketing for Pelvic Health

Boston Scientific | 2025-06-17

Boston Scientific has appointed Trent Campbell as Vice President of Marketing, Pelvic Health. Campbell previously contributed to Axonics' notable market successes and is now poised to strengthen Boston Scientific's market leadership in urology and pelvic health, indicating continued strategic emphasis on commercial growth and patient engagement.

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Ehud Gelblum joins iota Biosciences as CFO

iota Biosciences | 2025-06-16

iota Biosciences, powered by Astellas, has welcomed Ehud Gelblum as Chief Financial Officer. Gelblum brings extensive finance and technical leadership from successful tenures at Flatiron Health and a range of healthcare startups, blending venture experience with deep R&D insight. His appointment prepares iota Biosciences for its next phase of scaling within the neurotechnology landscape.

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Hyperfine Announces Key Executive Appointments to Strengthen its Leadership Position in AI-Powered Portable MRI

Hyperfine | 2025-06-11

Hyperfine has expanded its leadership team with Rob Fasciano, PhD, as Chief Regulatory and Quality Officer, and Rafael O'Halloran, PhD, as Vice President of Technology. Dr. Fasciano brings over 25 years in regulatory affairs and quality systems, while Dr. O'Halloran is recognized for driving AI-powered MRI advancements at Hyperfine and in academic institutions. Their roles will focus on global commercialization and technological innovation in portable brain imaging, supporting the Swoop® system's ongoing market rollout.

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Emily Johns Appointed as General Counsel

GlobeNewswire | 2025-06-03

NeuroOne Medical Technologies has named Emily Johns as General Counsel and Corporate Secretary, aligning with its strategic scaling. Johns, previously a partner at Honigman LLP and a seasoned public company counsel, brings a robust legal background and growth expertise. Her appointment is paired with incentives for other newly promoted leadership, evidencing NeuroOne's commitment to expanding its management bench to support accelerated business development and regulatory compliance.

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Leadership Impact Analysis

This wave of leadership changes and executive appointments demonstrates an industry-wide drive to bring in seasoned, multidisciplinary talent to support aggressive growth, technology commercialization, and regulatory advancements in neurotechnology. The new CEOs and board-level leaders, such as those at Avivomed, THYNK, and Tulavi, underscore a focus on scaling innovation, achieving regulatory milestones, and preparing for larger commercial or strategic transitions. The recruitment of experts in neuromodulation, AI, and regulatory affairs at firms like Ruten, Hyperfine, and Evren Technologies signals a deliberate strengthening of technical and scientific capabilities to remain competitive in an evolving landscape. Similarly, senior functional appointments—such as at iota Biosciences and NeuroOne—stress the criticality of robust financial and legal governance as companies transition from innovation to commercialization.

Executive Trend Conclusion

A recurring trend is the infusion of executive talent with deep expertise in both innovation and commercialization, bridging the gap between R&D and go-to-market execution. The prominence of advisors and board members with track records in successful exits, IPOs, or large-scale regulatory approvals suggests that neurotechnology companies are positioning themselves not just for scientific breakthroughs but also for market leadership and eventual strategic transactions. The convergence of scientific, financial, and legal leadership in this round of appointments highlights the industry's maturation, with organizations prioritizing seasoned stewardship to navigate forthcoming growth phases and regulatory demands.

Closing Thoughts

Key Strategic Insights

The past month's neurotechnology news cycle signals a market in accelerated convergence mode—where capital, policy, clinical outcomes, and commercial ambition are collectively pushing the boundaries of what is possible, and redefining what is expected. Non-invasive, AI-enabled devices attracted marquee funding and generated major downstream ripples: from Sanmai's $500 brain wearable to the MW20 EEG earphones, these advancements signal that seamless human-computer integration is moving quickly toward mainstream, consumer-mediated mental health and cognition. Parallel regulatory waves—FDA nods for wearable neurostimulation, surgical robotics, and mapping software—demonstrate that innovation is now running not only at the technical and scientific edge, but also increasingly within accepted regulatory frameworks. At the clinical interface, the tangible benefits of advanced BCIs and neuromodulation are no longer aspirational but quantifiable in better patient communication, functional recovery, and substantial health economic savings. Market-wise, bold commercial moves, high-velocity product launches, and strategic leadership appointments indicate that industry players are orchestrating their ascent with fresh expertise, positioning themselves for a mature phase of scale, competition, and cross-sector infusion.

Cross-Functional Analysis

These stories jointly highlight an ecosystem breaking down silos: investors, clinicians, engineers, and regulators are now directly collaborating to collapse timelines between scientific discovery, clinical validation, and full-scale adoption. The interplay between consumer and clinical-grade technology is increasingly fluid—"wellbeing" products quickly find medical relevance, and regulated neurodevices are now in the hands of patients at home. AI and advanced analytics are a universal lever, powering both diagnostic breakthroughs (age-specific autism biomarkers, deep-learning EEG platforms) and individualized therapies (precision rTMS, closed-loop VNS), while also informing smarter business and regulatory decision-making. Leadership trends further amplify this fusion; companies are actively recruiting executives with experience in both pioneering innovation and operational scale to ensure seamless translation from research bench to global market. Ultimately, cross-functional integration is driving not only product development but also the very models by which neurotechnology is delivered and monetized.

Future Outlook & Recommendations

The sector is clearly on the cusp of large-scale transformation: expect boundary-blurring partnerships, more hybrid clinical-consumer devices, and a heavy uptick in M&A as companies seek differentiated scale and defensible market share. Executives must prioritize strategic agility—pursuing regulatory engagement early, supporting modular product design for multi-market applicability, and investing in educational pipelines to expand talent and user bases. Operational readiness is now as critical as technological innovation; robust financial, legal, and regulatory infrastructure will be deciding factors as market leaders contend with rapid uptake and inevitable competitive pressures. Continued investments in AI and data platforms will be essential, driving personalization at scale across diagnostics and therapeutics. The ultimate winners will be those organizations that anticipate and shape this convergence, positioning themselves as trusted, versatile partners for patients, clinicians, and payers alike.

Final Word

Neurotechnology is no longer just a promise—it is an ecosystem in full acceleration, with every signal pointing toward integrated, personalized, and accessible brain health solutions. Savvy leadership and adaptive strategy will distinguish those who not only keep pace with the wave but define its direction.

© 2025 Carter Sciences. All rights reserved.

This newsletter is compiled for professionals in the Neurotechnology industry.

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