Explore our FDA-cleared and CE-ready bio-sensing devices, tremor-suppression systems, and precision micro-seismographic neural monitoring instruments designed for clinical and home care deployment across Barcelona and Southern Europe.
Designed for physical therapy centers across Catalonia, this calibrated mechanical tremor bar integrates dynamic kinetic feedback to stabilize hyperkinetic involuntary movements during post-stroke and neuromuscular rehab routines.
Constructed from bio-compatible elastic PP polymers, the Felix Stick generates high-frequency micro-oscillations designed to trigger deep neuromuscular recruitment during biofeedback sessions in movement disorder clinics.
A specialized non-invasive stimulation accessory utilizing multi-frequency thermal-vibrational feedback to calibrate sensory pathways and modulate reflex arcs in patient-controlled motor assessment therapy.
A high-tensile flex bar engineered for targeted proprioceptive neuromuscular facilitation (PNF). Ideal for Barcelona healthcare providers delivering non-pharmacological tone management programs.
High-sensitivity micro-seismographic sensor architecture modified for physiological wave sampling, capturing high-resolution muscular oscillations to benchmark digital therapeutic intervention efficacy.
Built with medical-grade non-allergenic rubber handles, this removable vibrating rod aids posture dynamics and core stability for neuromuscular rehabilitation regimens in geriatric physical therapy hubs.
An advanced analytical diagnostic instrument optimized for bio-mechanical monitoring laboratories and clinical trial centers, evaluating micro-tremor velocity profiles in motor control research.
A modular elastic training rod designed for rapid assembly, providing clinical-grade resistive resonance to target upper-body essential tremor conditions during home-based therapeutic sessions.
Bridging over two decades of neural signal decoding expertise with ISO 13485 cleanroom contract manufacturing to power the next generation of software-and-hardware integrated medicine.
Traditional medical devices deliver fixed, pre-programmed stimulation doses that fail to adapt to the dynamic physiological shifts of individual patients throughout the day. Our flagship technology—exemplified by the Felix NeuroAI™ Wristband platform and the Fasikl-X™ Nerve-Computer Interface—fundamentally transforms this standard. By integrating multi-channel surface biosensors directly into high-durability wearables, our hardware captures real-time neuromuscular electrical signatures through intact skin.
Proprietary filtering algorithms on edge microprocessors separate pathological tremor frequencies from voluntary motor movements. These decoded biosignals are transmitted to cloud-based neural AI models that continuously map the user’s dynamic "tremor fingerprint." The system then commands localized peripheral nerve stimulation to modulate pathological neural circuits at the wrist. This continuous loop—Sense, Decide, Treat—delivers individualized therapeutic efficacy without the surgical risks of Deep Brain Stimulation (DBS) or the systemic side effects of pharmacological therapies.
From rapid prototyping in cleanrooms to regulatory dossier preparation for AEMPS and European Notified Bodies, our manufacturing ecosystem simplifies DTx market entry.
Our manufacturing sites maintain Class 8 cleanrooms dedicated to bio-compatible polymer processing, precision SMT surface mount electronic assembly, and automated micro-sensory calibration.
We supply OEM sub-assemblies featuring custom electrode arrays, high-SNR analog front-ends (AFE), and ultra-low-power Bluetooth/Wi-Fi telemetry tailored for real-time cloud AI signal processing.
We deliver comprehensive technical dossiers (STED), biocompatibility documentation (ISO 10993), cyber-security compliance, and risk management validation (ISO 14971) for European market access.
Barcelona stands as a premier European hub for life sciences, home to world-renowned research institutes, public healthcare networks under CatSalut, and digital health innovation hubs.
The Metropolitan Area of Barcelona (AMB) represents a unique healthcare market where the public system—Servei Català de la Salut (CatSalut)—increasingly integrates validated digital health solutions (Digital Therapeutics) to lessen the burden of chronic neurodegenerative conditions on tertiary hospitals.
Our bio-electronic hardware and peripheral nerve stimulation wristbands are engineered for direct integration into clinical trial workflows at academic centers such as Hospital Vall d'Hebron, Hospital Clínic de Barcelona, and the Sant Pau Biomedical Research Institute.
Clinical Focus Area: Non-pharmacological essential tremor management, post-stroke motor function retraining, and outpatient neuro-rehabilitation monitoring across Catalonia's primary care centers (CAPs).
Understanding the shifting regulatory, reimbursement, and industrial landscapes governing software-as-a-medical-device (SaMD) and connected neuro-rehabilitation devices in Southern Europe.
European buyers and medical device distributors in Barcelona are under heightened pressure following the full implementation of EU MDR 2017/745. Hardware connected to algorithmic software classified as Digital Therapeutics must meet rigorous clinical evaluation standards. Furthermore, with the rollout of the EU Artificial Intelligence Act, Neuro-AI platforms utilizing closed-loop feedback loops require strict transparency, risk classification, and cybersecurity audits.
Our manufacturing facilities operate with complete traceability, providing European partners with full design history files (DHF), biocompatibility testing data (ISO 10993-1), and pre-validated software development lifecycle compliance (IEC 62304).
As Spain’s Spanish Agency of Medicines and Medical Devices (AEMPS) and regional health authorities like CatSalut streamline pathways for prescription digital therapeutics, medical equipment suppliers are shifting away from passive physical tools toward smart, sensor-enabled biofeedback systems.
Hospitals and outpatient providers demand devices capable of generating objective, quantifiably measurable clinical outcomes. Hardware suppliers capable of delivering built-in signal telemetry and standardized data exports allow DTx operators to demonstrate real-world evidence (RWE) required for national public health coverage and insurance reimbursement.
Environmental sustainability policies across the European Union require medical technology vendors to prioritize eco-conscious packaging, lead-free RoHS-compliant PCB manufacturing, and localized warehousing near major logistics hubs like the Port of Barcelona Free Trade Zone (Zal Port) and Josep Tarradellas Barcelona-El Prat Airport. Our optimized global freight routing ensures rapid sample fulfillment and bulk container delivery straight into Catalonia's biomedical logistics corridors.
Addressing common queries regarding OEM/ODM customization, regulatory documentation, local supply chain logistics, and clinical sample fulfillment.
Yes. Our medical wearable lines and bio-sensing electronics are manufactured in full compliance with European Medical Device Regulation (EU MDR 2017/745). We provide complete CE declaration of conformity documentation, technical files, and clinical evaluation reports required for commercialization across Spain and the broader European Economic Area (EEA).
Absolutely. We specialize in contract manufacturing for DTx venture platforms, pharmaceutical brand extensions, and private healthcare hospital groups. Customization options include custom enclosure tooling, bio-compatible strap materials, tailored Bluetooth protocol integration, private-label branding, and custom firmware optimized for your cloud API software.
Air-freight express shipments for clinical evaluation samples and prototype batches typically arrive in Barcelona within 5 to 7 business days via El Prat Logistics Center. Standard production container orders shipped to the Port of Barcelona require approximately 25 to 35 transit days, complete with automated import customs clearance paperwork.
Our connected sensory devices do not store personally identifiable patient information (PII) on the physical device level. Raw bio-signal micro-data is encrypted at rest using AES-256 and transmitted via secure, TLS-encrypted Bluetooth Low Energy (BLE) channels directly to authorized, GDPR-compliant EU cloud servers managed by your healthcare organization.
Unlike oral pharmaceuticals (such as beta-blockers or anticonvulsants) which often cause cognitive fatigue, sedation, or loss of efficacy over time, or invasive neurosurgeries like Deep Brain Stimulation (DBS), our wrist-worn non-invasive nerve stimulation technologies deliver targeted closed-loop motor modulation directly through peripheral nerves, presenting zero surgical risk and immediate dynamic control.
Yes, we maintain flexible MOQ structures specifically designed to accommodate pilot clinical trials, academic research grants at Barcelona university hospitals, and early-stage market validation launches. Contact our supply management team to discuss scalable production tiers.
Whether you are a digital health company scaling a therapeutic software platform, a public health institution in Catalonia seeking innovative motor rehab devices, or an OEM medical distributor in Southern Europe, our team is ready to support your supply chain.
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