NeuroTech Newsletter #6
Executive Summary
Welcome to the 6th edition of the Carter Sciences Neurotech Newsletter!
Strong funding momentum across the sector with significant capital raises and regulatory wins driving the transition toward next-generation neurotherapeutics.
Robust capital inflows—from Salvia BioElectronics' $60M Series B and Syndeio Biosciences' $90M stealth launch to Neuralink's massive $600M round at $9B valuation—highlight investor confidence in implantable neuromodulation, synaptic repair pharmacology, and high-bandwidth brain-computer interfaces. FDA clearances for Hyperfine's Optive AI™ MRI software, VIVATRONIX's UNWIND cluster headache therapy, and Stryker's OptaBlate nerve ablation system demonstrate growing regulatory support for AI-enabled diagnostics and precision-targeted interventions, marking a shift from symptom management toward mechanism-based, circuit-level therapies.
Operationally, new AMA CPT codes for continuous EEG monitoring and expanding focused ultrasound trials are establishing a data-driven, personalized neurotherapeutic ecosystem. Strategic leadership appointments at Natus Neuro, Medtronic, Stimdia, Brainomix, Salvia, and ABILITY Neurotech underscore the critical importance of financial, regulatory, and R&D expertise in scaling global commercialization. Moving forward, companies should integrate regulatory and reimbursement planning into early R&D, pursue cross-sector partnerships between device, AI imaging, and biopharma players, and invest in health economics and real-world evidence generation. By late 2026, integrated platforms converging diagnostics, neuromodulation, and BCI capabilities will command premium valuations and drive strategic M&A activity.
Check out the highlights below and as always send through any recommendations or feedback to chay@cartersciences.com
Funding News
Salvia BioElectronics Secures $60M Series B
GlobeNewswire2025-05-27
Salvia BioElectronics completed a $60 million Series B financing led by Innovation Industries with participation from Invest-NL, the EIC Fund and existing investors to advance MySalvia Therapy, an ultra-thin implantable neuromodulation device for chronic migraine. The funding will support the ongoing RECLAIM multi-center, double-blind, sham-controlled trial, planned U.S. studies, and regulatory submissions for FDA market authorization alongside CE and TGA approvals. With FDA Breakthrough Device designation and a minimally invasive design featuring dual implants and an external wearable stimulator, MySalvia aims to reduce migraine frequency and intensity and shows potential in treating cluster headache.
Syndeio Advances Synapse Repair for CNS Disorders
FirstWord2025-05-27
Syndeio Biosciences emerged from stealth with $90 million in funding to propel its Boost Synapse Pharmacology Platform, designed to repair synaptic structure and function in central nervous system disorders. Its lead candidate, zelquistinel, an NMDAR positive allosteric modulator in Phase II for major depressive disorder, and a second NMDAR modulator, apimostinel, in Phase IIa for acute depression, will be evaluated alongside planned synaptic biomarker trials in Alzheimer's disease. The capital infusion enables integration of electrophysiology, behavioral assays and biomarker readouts to refine patient selection, dosing and trial design while exploring targets such as AMPAR, mGluR and 5HT2A to restore synaptic plasticity.
Neuralink Reaches $9B Valuation
Benzinga2025-05-27
Elon Musk's Neuralink secured $600 million in new financing, raising its valuation to $9 billion after demonstrating successful brain-chip implants in three individuals, including a non-verbal ALS patient. The round reflects growing investor confidence as Neuralink prepares to launch human trials of its Blindsight implant by 2026, targeting vision restoration for blind individuals. These milestones underscore the company's progress in brain-computer interface development and its potential to revolutionize healthcare and assistive communication technologies.
Summary
The recent wave of funding into implantable neuromodulation, precision synaptic therapeutics and brain-computer interfaces underscores a broader shift toward targeting neural circuits and synapses directly. These capital infusions will accelerate clinical development, expand regulatory strategies and foster collaborations across medtech, pharmaceutical and digital health sectors. By enabling advanced trial designs with sham controls and biomarker readouts, they promise to de-risk pathways for devices and therapies addressing migraine, depression, Alzheimer's and sensory deficits, thereby broadening the neurotechnology market and attracting further investment.
Collectively, these financings highlight a move from symptom management to functional restoration of neural networks, powered by minimally invasive hardware and data-driven pharmacology platforms. The surge in high-value rounds and skyrocketing valuations reflects growing investor appetite for neurotech ventures that blend implantable devices with precision biomarker strategies. This trend signals a maturing industry poised to redefine standard-of-care in neurological and psychiatric medicine through targeted circuit modulation and synaptic repair.
FDA News
Hyperfine Announces FDA Clearance of Optive AI™ Software
hyperfine.io2025-05-28
Hyperfine secured FDA 510(k) clearance for its Optive AI™ software upgrade to the Swoop® portable MRI system, delivering the most substantial image quality improvement at ultra-low-field strength to date. The AI-driven enhancement spans noise cancellation, acquisition, reconstruction and post-processing, producing brain images approaching 1.5 T clarity. A Q3 2025 rollout aims to expand access to advanced point-of-care neuroimaging in hospitals and neurology offices.
NeuroDiscovery AI partners with athenahealth
NeuroDiscovery AI2025-05-28
NeuroDiscovery AI launched its advanced AI-powered reporting and analytics platform on the athenahealth Marketplace, enabling neurology practices to integrate decision support tools directly within their EHR workflow. This marketplace integration streamlines adoption of AI-driven neurodiagnostic insights without additional regulatory filings, accelerating deployment across U.S. practices.
FDA Approved Breakthrough in Cluster Headache Treatment
VIVATRONIX2025-05-27
VIVATRONIX's UNWIND noninvasive neuromodulation therapy received FDA approval for acute and preventive cluster headache treatment, addressing one of neurology's most painful disorders. The device delivers rapid relief with zero pharmacologic side effects while reducing attack frequency and improving sleep quality. This first-of-its-kind FDA-endorsed therapy expands neuromodulation into headache management.
Stryker wins FDA clearance for minimally invasive back pain treatment
MedTech Dive2025-05-22
The FDA granted 510(k) clearance to Stryker's OptaBlate basivertebral nerve ablation system for chronic vertebrogenic low back pain, extending its indication beyond malignant spine lesions. Using targeted radiofrequency energy to lesion the basivertebral nerve in seven minutes, the minimally invasive procedure disrupts pain signals at the vertebral endplates. This expanded clearance positions Stryker as a challenger in the growing interventional back pain market.
Natus Launches BrainWatch EEG
PRNewswire2025-05-20
Natus Medical introduced BrainWatch™, a point-of-care EEG system for emergency and ICU settings, integrating FDA-cleared Persyst algorithms within the NeuroWorks platform. The wearable, wireless device sets up in under five minutes to deliver ACNS-compliant rapid EEG with on-device seizure detection and remote neurologist collaboration. BrainWatch aims to streamline acute neurodiagnostic workflows and enhance access in underserved hospitals.
Summary
These developments reflect a regulatory environment increasingly receptive to AI-driven imaging enhancements, minimally invasive therapies and point-of-care neurodiagnostics. FDA clearances for software upgrades like Optive AI and for new indications such as Stryker's OptaBlate system signal streamlined pathways for software as a medical device and expanded procedural uses. Approval of VIVATRONIX's UNWIND neuromodulation adds a nonpharmacologic therapy option for severe headache disorders, while Natus's BrainWatch launch underscores demand for rapid EEG in critical care. Concurrently, NeuroDiscovery's integration into athenahealth highlights how commercial partnerships leverage existing compliance frameworks to accelerate AI adoption without new filings. Together, these milestones lower barriers to advanced neurotechnology deployment, fostering broader clinical access and competitive innovation.
The convergence of AI-enhanced imaging, software-driven device upgrades and minimally invasive therapeutic clearances illustrates a maturing FDA stance toward digital health and neuromodulation. The agency's willingness to clear iterative software improvements and broaden device indications, combined with the rise of point-of-care solutions and EHR marketplace integrations, signals a trend toward decentralizing neurodiagnostics and embedding AI tools seamlessly into clinical workflows. This regulatory momentum is poised to drive rapid adoption of next-generation neurotechnologies across care settings.
Clinical News
Interim 36-Month Outcomes in Neurostimulation Study
Inner CosmosMay 21, 2025
Inner Cosmos has released interim data from its FDA-approved early safety and feasibility trial of a minimally invasive, skull-embedded neurostimulation device for treatment-resistant depression. Among three adult participants, no serious adverse events were reported and all exceeded prior TMS outcomes with symptom reductions of 41%, 83% and 54%, respectively. The mobile system enabled home-based delivery, sustained mood and functional gains, and demonstrated potential to overcome access and compliance barriers inherent to clinic-bound TMS.
AMA New CPT Codes for EEG Monitoring
EpiminderMay 17, 2025
The AMA has introduced five new Category III CPT codes to support interpretation, reporting and remote monitoring of continuous EEG data from Epiminder's sub-scalp implantable system for epilepsy. Developed in partnership with the American Clinical Neurophysiology Society, these codes—effective January 2026—will enable clinicians to bill for longitudinal EEG review and telemonitored care, laying the groundwork for broader adoption of implant-based seizure tracking and data-driven treatment adjustments.
Focused Ultrasound and Stroke Trials
FUS FoundationMay 15, 2025
Two recent clinical studies have demonstrated novel ultrasound applications in stroke recovery and diagnosis. In a Duke University Phase I neuromodulation trial, low-intensity focused ultrasound applied to the motor cortex in 18 post-stroke patients proved safe and yielded dose-dependent enhancements in motor learning and corticospinal excitability, supporting advancement into Phase II efficacy testing. Separately, UT Southwestern researchers used high-intensity focused ultrasound thalamotomy to trigger plasma GFAP release, identifying this protein as a promising biomarker for acute brain injury and stroke diagnosis pending further validation.
Summary
Collectively, these developments signal a shift toward minimally invasive, home-based neuromodulation and continuous physiological monitoring in neuropsychiatric and neurovascular care. Inner Cosmos' implantable device could redefine treatment paradigms for refractory depression by ensuring sustained, patient-controlled therapy outside the clinic. Simultaneously, the new EEG CPT codes will accelerate reimbursement for implantable monitoring platforms, empowering clinicians with real-time seizure data. Focused ultrasound research further expands noninvasive intervention and diagnostic capabilities for stroke, potentially enabling rapid therapeutic targeting and biomarker-guided patient stratification.
These articles reflect a convergence on remote-enabled, device-driven neurotherapies and diagnostics, underpinned by regulatory and reimbursement frameworks that support continuous monitoring. The field is moving toward personalized, network-targeted neuromodulation and blood-based biomarkers, with an emphasis on translating emerging technologies into scalable, patient-centered solutions.
Leadership Appointments
Tim Allen joins Natus Neuro as CFO
Natus Neuro2025-05-28
Natus Neuro has appointed Tim Allen as CFO to lead finance during its next growth phase. With extensive experience in medtech and manufacturing finance, Allen will drive strategic financial planning, enhance efficiency, and steer innovation investments to support the company's expansion in neurological diagnostics and monitoring.
Michael Carter joins Medtronic as SVP & President of Cranial & Spinal Technologies
Medtronic2025-05-22
Medtronic has named Michael Carter SVP & President of Cranial & Spinal Technologies, elevating him from his prior role as VP/GM of Spine & Biologics. Carter's two decades of medtech leadership and proven record in commercial and operational growth will guide CST's next chapter, reinforcing the division's momentum in surgical innovation and digital strategy.
Matthew McDonald joins Stimdia Medical as VP of R&D
Stimdia Medical2025-05-22
Stimdia Medical has appointed Matthew McDonald as VP of R&D to accelerate its pdSTIM neuromodulation system trial for ventilated patients. McDonald, formerly R&D director at Boston Scientific Neuromodulation, brings deep expertise in device design and innovation leadership to advance Stimdia's clinical programs and technology pipeline.
Eyal David joins BlueWind Medical as VP of R&D and Site Director
BlueWind Medical2025-05-22
BlueWind Medical has named Eyal David VP of R&D and Site Director, leveraging his two decades of communications expertise and six years in MedTech. David will oversee cross-functional development teams and drive scalable R&D initiatives, reinforcing the company's efforts in peripheral nerve stimulation solutions.
Brainomix Appoints Khush F. Mehta as Chair
PR Newswire2025-05-21
Brainomix has appointed Khush F. Mehta as Board Chair to steer its global expansion in AI-driven stroke and lung fibrosis imaging. Mehta brings over 20 years of strategic leadership in healthcare AI and regulatory markets, aiming to scale Brainomix's Footprint post-Series C investment and recent FDA breakthroughs.
Salvia Appoints VP Clinical & Regulatory Affairs
Salvia BioElectronics2025-05-20
Salvia BioElectronics has promoted Roni Diaz to VP Clinical & Regulatory Affairs to propel its MySalvia neuromodulation therapy toward approval. Diaz, the company's first US hire and former BlueWind Medical leader, will orchestrate pivotal trials and regulatory strategy to accelerate market entry in migraine treatment.
Summary
This wave of appointments underscores a strategic pivot across the neurotechnology sector toward bolstering R&D capabilities, advancing clinical and regulatory pathways, and strengthening financial leadership. With Medtronic and Natus Neuro reinforcing senior roles in operations and finance, and specialized firms like Stimdia, BlueWind and Salvia enhancing technical and regulatory expertise, companies are aligning leadership to expedite product innovation, secure approvals, and scale global commercialization.
Across senior roles, the industry is drawing on seasoned medtech executives with cross-domain experience to navigate complex regulatory environments and fast-evolving technology landscapes. There is a clear emphasis on integrating commercial acumen with deep technical and clinical insights, signaling a maturing sector focused on sustainable growth, strategic investment, and widening global footprints.
Closing Thoughts
Key Insight Summary: This issue reveals a neurotechnology sector transitioning from siloed symptom management to integrated restoration of neural function through targeted circuits and synapses. The surge in high-value financing for implantable neuromodulation, synaptic pharmacology platforms, and brain-computer interfaces, coupled with the FDA's embrace of AI-driven imaging and noninvasive neuromodulation, underscores a maturing industry poised to deliver precision therapies across migraine, mood, seizure, and sensory disorders.
Cross-Domain Analysis: Capital influx is directly enabling advanced, sham-controlled and biomarker-driven trials, whose positive safety and efficacy data in depression, stroke, and headache feed regulatory approvals and new reimbursement pathways. Simultaneously, strategic leadership hires in finance, R&D, and regulatory affairs are aligning organizational capabilities to scale and commercialize these breakthroughs globally, creating a virtuous cycle of investment, validation, and go-to-market readiness.
Actionable Recommendations & Forecasts: Executives should prioritize partnerships that bridge medtech, pharmaceutical, and digital health sectors to refine patient selection and trial design around emerging biomarkers. Budget allocations must account for AI-enhanced imaging deployments and remote-enabled device rollouts, while regulatory roadmaps anticipate evolving CPT codes and 510(k) standards. Expect consolidation around platforms that integrate at-home neuromodulation, continuous monitoring, and data analytics by late 2026, creating opportunities for value-added services and subscription models.
Forward Momentum Conclusion: As funding streams, regulatory support, and clinical momentum converge under fortified leadership teams, the neurotechnology ecosystem is set to redefine standard-of-care through personalized, network-targeted interventions. Stakeholders who integrate these insights will be best positioned to deliver next-generation therapies that transform patient outcomes and reshape market dynamics.
© 2025 Carter Sciences. All rights reserved.
This newsletter is compiled for professionals in the Neurotechnology industry.
