Medical-Grade Digital Biomarker Wearables & Hardware
Explore our CE-MDR certified and clinically validated screenless smart bracelets engineered for continuous physiological data collection, decentralised clinical trials (DCTs), and remote patient monitoring across Paris.
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Medical-Grade Continuous Vital Signs & Digital Biomarker Infrastructure
Bridging the gap between clinical ward spot-checks and decentralized pharmaceutical research through continuous multi-sensor telemetry, validated signal processing algorithms, and open API architecture.
1. The Paradigm Shift: Continuous Monitoring vs. Episodic Spot-Checks
In traditional clinical environments—including major hospital networks across Paris and the broader Île-de-France region—patient vital signs are historically captured through manual nursing rounds every 4 to 8 hours. This episodic measurement paradigm creates substantial clinical blind spots. Physiological deterioration, sudden cardiac events, drug toxicity responses, and respiratory distress often develop rapidly within these unmonitored windows, leading to delayed interventions, higher ICU transfer rates, and prolonged hospital stays.
Our CE-MDR certified digital biomarker platform fundamentally alters this paradigm. By capturing continuous continuous physiological telemetry—deriving up to 19 distinct vital parameters directly from a lightweight, screenless wrist-worn wearable—clinicians and clinical trial sponsors transition from reactive snapshot management to proactive, data-driven trajectory analysis.
2. Multi-Sensor Data Acquisition Architecture & Raw Signal Access
Unlike consumer-grade smartwatches that restrict data output to proprietary, pre-aggregated heuristics, our pharmaceutical digital biomarker platform offers unrestricted access to high-fidelity, raw multi-sensor telemetry. Designed under strict ISO 13485 quality standards, the CardioWatch architecture captures raw signals at sampling frequencies up to 128 Hz across five primary sensor modalities:
Single-Lead ECG
High-resolution electrocardiogram strips for precise arrhythmia detection, QT interval tracking, atrial fibrillation monitoring, and heart rate variability (HRV) feature extraction.
Multi-Wavelength PPG
Green, Red, and Infrared photoplethysmography sensors for continuous blood oxygen saturation (SpO2), pulse wave velocity, peripheral microcirculation, and respiration rate estimation.
Skin & Core Temperature
Continuous thermal sensing for fever onset tracking, inflammatory cascade monitoring, and circadian rhythm variations in oncology and immunology trials.
3-Axis Accelerometry
Granular motion analytics providing objective mobility scoring, posture classification, fall detection, tremors, and sleep stage architecture analysis.
Galvanic Skin Response (GSR)
Electrodermal activity monitoring for real-time autonomic nervous system stress response measurement and pain index modeling.
IP-Free Open APIs/SDKs
Unrestricted payload access via documented RESTful APIs and mobile SDKs, allowing seamless integration into custom EMR, electronic Clinical Outcome Assessment (eCOA), and AI pipelines.
Global Clinical Footprint & Data Reliability
Our medical-grade hardware and cloud platform back millions of patient monitoring hours across leading academic medical centers, contract research organizations (CROs), and pharmaceutical leaders.
Tailored Application Scenarios serving Paris Healthcare & Life Sciences
How Parisian hospital systems, clinical research networks, and biotechnology firms deploy our digital biomarker platform across acute care and decentralized trial pathways.
1. AP-HP & Regional Hospital General Ward Continuous Telemetry
Within major public hospital networks like the Assistance Publique – Hôpitaux de Paris (AP-HP) and private healthcare facilities across Île-de-France, acute care wards utilize our continuous smart bracelets to replace traditional manual vitals documentation. By feeding continuous pulse rate, SpO2, respiration, and temperature directly into hospital Electronic Health Records (EHR), nursing teams reduce manual observation workloads by up to 60% while eliminating transcription errors and enabling early detection of patient deterioration.
2. Decentralized Clinical Trials (DCTs) in the Paris BioMed Cluster
Paris hosts one of Europe’s densest clusters of pharmaceutical companies, clinical trial CROs, and biotech startups (e.g., along the Seine Valley and Biotech Santé networks). Sponsors running Phase I-IV decentralised clinical trials leverage our screenless wearables to continuously track drug efficacy and safety endpoints in ambulatory patients. High participant compliance is maintained through screenless, zero-interaction hardware that operates autonomously in the background.
3. Post-Discharge Ambulatory Care (Hôpital à Domicile - HAD)
Under French Hôpital à Domicile (HAD) post-discharge care frameworks, patients recovering from major cardiac procedures, oncology therapies, or severe respiratory infections are discharged home wearing the same bracelet assigned during ward admission. This unbroken continuity of care ensures immediate notification if secondary complications or readmission risk indicators emerge, aligning with French national health system goals to reduce hospital re-admission rates.
4. Early Warning Alerting & Cardiac Research Partnerships
In collaboration with leading European cardiology networks and research institutions (such as participating teams in the European DETECT consortium and Hôpital Foch in Paris region), our platform’s continuous high-frequency PPG and ECG signals are analyzed by machine learning models to detect silent atrial fibrillation, nocturnal apneas, and predictive indicators of out-of-hospital cardiac arrest.
Navigating Paris & French Digital Health Ecosystem Trends
Key regulatory, technological, and market drivers shaping the adoption of wearable digital biomarker platforms in France.
The Impact of 'France 2030' & Ségur de la Santé Digital Mandates
France’s national healthcare acceleration strategy, driven by the Ségur de la Santé and the France 2030 Healthcare Plan, emphasizes the digitization of patient pathways, interoperability through shared European standards, and the adoption of AI-driven remote monitoring algorithms. Manufacturers and suppliers providing digital biomarker platforms to Paris must meet stringent criteria:
- EU MDR Certification (Regulation 2017/745): Compliance with CE-MDR Class IIa/IIb certification is non-negotiable for clinical deployment in French medical institutions. Consumer smartwatches lacking notified-body medical clearance cannot be used for diagnostic documentation or regulatory trial submissions.
- GDPR & HDS Data Hosting Sovereignty: Health data collected within France must comply with strict Hébergeur de Données de Santé (HDS) certification standards and GDPR mandates. Our cloud architecture guarantees end-to-end data encryption, localized EU data residency, and patient anonymity protection.
- Interoperability via HL7 / FHIR APIs: Modern French hospital software stacks require frictionless API connectivity. Our open architecture allows direct RESTful API and Mobile SDK telemetry streaming into local hospital information systems (HIS).
Why Leading Global & European Healthcare Providers Trust Corsano
Engineered under Swiss and Dutch precision, backed by notified body Kiwa medical certifications, ISO 13485 quality systems, and verified clinical publications.
Regulated Medical Manufacturer
Full CE-MDR certification and FDA 510(k) clearance. Designed and audited under ISO 13485 quality management systems specifically for continuous patient care.
IP-Free Raw Signal Access
Pharmaceutical sponsors retain 100% intellectual property rights over algorithms developed on top of our raw 128 Hz accelerometer, PPG, ECG, GSR, and temperature data streams.
Patient-First Ergonomics
Ultra-lightweight, screenless, and water-resistant designs offering 14+ days of continuous battery life without requiring patient interaction or daily charging routines.
Unified Ecosystem: CardioWatch 287 medical bracelet, patient gateway application, and clinician monitoring web dashboard.
Collaborating with Global Healthcare & Research Leaders
Our platform powers major international research consortia including Eurostars LifeTime, Horizon 2020 Watch-It, and the Dutch Heart Foundation DETECT project alongside world-class institutions:
Frequently Asked Questions by Paris Procurement Teams & Researchers
Clear answers regarding medical certification, data sovereignty, clinical trial logistics, and integration protocols for organizations serving the French market.
Which continuous vital signs does the digital biomarker platform capture?
The platform captures up to 19 continuous physiological metrics including heart rate, continuous heart rate variability (HRV), respiration rate, blood oxygen saturation (SpO2), skin temperature, activity index, posture classification, sleep staging, electrodermal activity (GSR), and single-lead ECG rhythm waveforms sampled up to 128 Hz.
Is the platform fully certified under European Medical Device Regulation (CE-MDR)?
Yes. Unlike consumer fitness wearables, the platform is certified as a medical device under EU MDR 2017/745 through notified body Kiwa and carries FDA 510(k) clearance. Manufactured under strict ISO 13485 standards, all derived algorithms undergo rigorous clinical validation against hospital reference monitors.
Can research teams in Paris access raw PPG and ECG data for proprietary AI development?
Absolutely. We provide full IP-free raw data access (accelerometer, tri-wavelength PPG, ECG, GSR, temperature) at 128 Hz via open SDKs and REST APIs. Pharmaceutical sponsors and academic AI laboratories retain 100% intellectual property over digital biomarkers developed using our hardware data streams.
How does the platform ensure data protection and GDPR/HDS compliance in France?
Data security is built-in by design. All patient telemetry is end-to-end encrypted (AES-256 in transit and at rest). Cloud infrastructure supports deployment on certified French Health Data Hosting (HDS) servers and GDPR-compliant European cloud nodes, ensuring full data sovereignty.
How does the wearable integrate with local hospital Electronic Medical Record (EMR) systems?
Our cloud engine provides documented RESTful APIs, HL7, and FHIR integration interfaces. Continuous vital signs and automated Early Warning Scores (EWS) stream directly into nursing station dashboards, central hospital telemetry systems, or partner electronic health records without altering established workflows.
What is the battery autonomy and compliance management model for home-bound patients?
The screenless wearable design maximizes patient compliance and energy efficiency, offering 14+ days of uninterrupted battery autonomy on a single charge. The lack of interactive screens prevents patient anxiety and accidental setting modifications during home monitoring phases.
Accelerate Your Digital Biomarker & Clinical Telemetry Initiatives in Paris
Speak with our clinical solutions engineering team to request sample evaluation units, review clinical validation whitepapers, or schedule an API integration demonstration.
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