Neurology

Salvia Bioelectronics Secures $60M In Series B To Advance Chronic Migraine Implant, Eyes US Trials

 
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Medtech Insight spoke with Hubert Martens, CEO of Netherlands-based neuromodulation company Salvia Bioelectronics, about the company’s innovative implant for treating chronic migraines, ongoing clinical trials and plans for US clinical trials and commercialization.

First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 

Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.

Synchron And Apple Team Up To Use ‘Mind-Thought Connection’ To Control iPhones, iPads

 
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Apple and Synchron are teaming up to develop technologies that will one day allow people who can’t use their hands or voice to control iPhones, iPads and other Apple devices by using only their thoughts.

Axoft Starts Commercializing Soft BCI-Enabling Materials For R&D Use, Aims To Rewrite BCI Playbook

 
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After publishing encouraging results from first-in-human trials of its brain-computer interface, Axoft announced plans to sell its BCI-enabling material Fleuron to researchers and private organizations for R&D use. The company sees this as a revenue stream and feedback loop to refine its BCI platform designed for safer, longer-lasting brain implants.


Consumer Healthtech Investment Totaled $4.5BN In 2024, But Bar Is High Amid Economic Uncertainty

 
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Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.

California Medtech Firms Resolve Patent Dispute Over Delivery Catheters

 

Route 92 says it has reached a settlement with Q’Apel Medical over patent claims concerning its Tenzing delivery catheters.

Subsense Develops Nonsurgical, Nanoparticle-Based Brain-Computer Interface For Neurological Disorders

 
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Neurotechnology start-up Subsense came out of stealth with $17m in seed funding to develop a nonsurgical, nanoparticle-based brain-computer interface. Medtech Insight spoke with the firm’s new neurotech lead Cyril Eleftheriou about the technology and its potentially wide applications for treating Parkinson’s, epilepsy, inner speech decoding, and more.

New Treatment For Chronic Facial Pain Could Launch By Fall 2025

 
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NeuroOne is preparing to submit its OneRF Trigeminal Nerve Ablation System to the US FDA for treating trigeminal neuralgia, a chronic facial pain condition. CEO Dave Rosa told Medtech Insight that he expects a possible product launch by fall 2025.


Q’Apel Medical Recalls, Discontinues Stroke Therapy System After FDA Warning Letter, Class I Designation

 

Q’Apel Medical has pulled its aspiration system for stroke thrombectomy from the market after concerns raised by the US FDA in a February warning letter.

Biolinq’s $100M In Series C Financing Supports Efforts To Bring Diabetic Glucose Monitoring With Needle-Free Patch To Market

 
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Biolinq plans to use the proceeds of its new venture funding to support US FDA de novo review, automation engineering and commercialization efforts with partners, CEO Rich Yang told Medtech Insight.

FDA Issues A Pair Of Early Alerts For Intravascular Catheters

 

The US FDA continues to issue early alerts as part of its communications pilot aimed at improving how the agency manages recalls. This time, the agency is notifying users about two separate intravascular catheters.

Upcoming CMS Meetings Address Tremor-Control Devices, Lab Test Reimbursement

 
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The US Medicare agency will hold three public meetings in June and July addressing tremor treatment devices and clinical diagnostic lab tests. The first meeting on June 25 will focus on endpoints for Parkinson’s device trials, while subsequent meetings will address payment rates and codes for laboratory tests.


Precision Neuroscience’s FDA Clearance For Core Component Of Brain Implant Expected to Accelerate R&D

 
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Precision’s recent FDA clearance for a core part of its next-generation wireless brain-computer interface system opens the pathway to a safer, more humane BCI for researchers to use compared to higher-risk intracortical arrays, according to BCI expert Naveen Rao.

THENA Capital ‘Makes History’ As UK’s First All-Female Early-Stage Medtech Fund

 

Only 16% of venture capital general partners in Europe are women, and only 9% of those have actual investment power. Thena Capital is aiming to "redefine the image of a venture capitalist."

Wired Health: ‘Early Diagnosis Often Benefits Science But Not The Patient’

 

Early diagnosis can be “detrimental” to patients, Suzanne O'Sullivan, neurologist and author of “The Age of Diagnosis,” argued at the Wired Health conference on 18 March. "You save one life from screening 2,000 women for breast cancer, but you also treat 10 women unnecessarily," she said.

Barcelona’s S2 Xpeed Accelerates Hardware-Based Medtech Start-Ups From Prototype To Market

 
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Barcelona-based accelerator S2 Xpeed is driving the rapid growth of medtech and hardware start-ups in Europe. Operating under a "sweat equity" model, the program helps early-stage companies move from prototype to manufacturing readiness in exchange for equity. This month, the accelerator will add a fourth cohort of 10 more start-ups, five of which are in the medtech space.


Class I Recall On Medtronic Embolization Device After 4 Deaths

 
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The company is recalling Pipeline Vantage 021 and 027 models because they pose a higher than normal risk of failing to properly attach to blood vessel walls, which can cause thrombosis, stroke or death. The recall for 027 is a product removal and for 021 is an update to the instructions for use.

AAOS 2025: AcuityMD Study Finds Innovation Continues To Drive Outpatient Spinal Procedures

 
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A new study by AcuityMD, presented at AAOS 2025, highlights the continued shift of spinal surgeries to the outpatient setting, with state-by-state variability in ASC adoption. While hospitals still dominate spinal procedures, advancements in minimally invasive techniques and medical technologies are major drivers of spinal surgeries in the ASC setting.

Neuromod Raises $10.9M To Grow US Reach And Further Real-World Evidence

 

Dublin-based Neuromod has closed a €10m ($10.9m) series B funding round to bring a "new standard of care" to patients with tinnitus.

Medtronic Widens Parkinson’s aDBS Opportunity With Key US Approvals

 

Medtronic’s US FDA approval for BrainSense aDBS and BrainSense EI software features of the Percept neurostimulator device has quickly followed CE marking in January.