In which regions and regulatory frameworks is the Corsano CardioWatch available?

The Corsano CardioWatch platform is CE-MDR certified as a Class IIa medical device in Europe and FDA 510(k) cleared in the United States. In other worldwide jurisdictions, it is available as an Investigational Device or for research evaluation under ISO 13485 quality standards.

What are the physical dimensions and battery life specs of CardioWatch 287-2?

CardioWatch 287-2 weighs 18 grams with physical dimensions of 24.4 x 40.4 x 9.8 mm. It features up to 15 days of battery life depending on active sensor sampling rates, 8MB on-device flash memory, and charges fully in 3 hours using a self-aligning magnetic USB charger.

Which vital parameters and raw signals can be extracted from the wearable?

CardioWatch derives up to 19 vital parameters including Pulse Rate, Heart Rate Variability (HRV), SpO2, Respiration Rate, Core Body Temperature, NIBP, Sleep Staging, Activity, and Posture. Unrestricted raw signals for 3-axis Accelerometer, multi-wavelength PPG (Green/Red/Infrared), and BioZ/ECG are exportable up to 128 Hz.

How does Corsano ensure data security and compliance with international standards?

The Corsano cloud architecture is hosted on Amazon Web Services (AWS) with full encryption at rest and in transit. The system fully complies with GDPR, HIPAA, and ISO 27001 data security guidelines with strict role-based access control.

How has the CardioWatch 287 platform been clinically validated?

Core algorithms have undergone analytical and clinical validation in university hospitals and consortia, including RadboudMC, ErasmusMC, Haaglanden Clinics, Reinier de Graaf, and CMC for parameters such as SpO2 across all Fitzpatrick skin types (I-VI), pulse rate, respiration rate, and cardiac arrhythmia detection.

FAQ | Corsano Health Medical-Grade Continuous Vital Signs Monitoring

CE-MDR Certified Class IIa Medical Device
FDA 510(k) Cleared Platform
ISO 13485 Manufactured Quality System
GDPR & HIPAA Compliant Security
Raw Multi-Sensor Data Export up to 128 Hz

Medical Wearable FAQ

Technical, Regulatory & Clinical Procurement Insights

Designed as a configurable, single-purpose medical bracelet, the Corsano CardioWatch platform combines multi-sensor vital sign acquisition with non-invasive continuous patient monitoring for hospitals, CROs, and remote care teams.

1. Availability & Regulatory Status

In which countries is the Corsano CardioWatch 287 certified and available for procurement?

The Corsano CardioWatch 287 platform is CE-MDR certified (Class IIa Medical Device under EU MDR regulations audited by Kiwa) in Europe and FDA 510(k) cleared in the United States. In other international jurisdictions, CardioWatch is supplied as an Investigational Device or research monitor under ISO 13485 quality standards, adhering to local regulatory requirements for clinical trials and post-discharge evaluation.

How quickly can global healthcare institutions or research teams launch a study with Corsano?

Study leads and hospital administrators can configure new protocols, set vital sign thresholds, and provision wearable devices in the Corsano Research Portal within minutes. Standard compliance documentation, including Data Processing Agreements (DPA) and legal transfers, typically complete within 1 to 2 months depending on regional ethics committee requirements.

2. Hardware & Technical Specifications

What is the battery operational life, memory storage, and charging mechanism of CardioWatch 287-2?

CardioWatch 287-2 features an operational battery life of up to 15 days on a single charge. Battery performance varies based on active sensor configurations, PPG optical sampling modes, and transmission intervals.

On-Device Memory: Up to 8MB internal flash storage, preventing data loss during wireless connection dropouts.
Low Power Safeguard: Automatically shifts into Low Power Mode when capacity drops, notifying clinical staff via the gateway application.
Recharging Time: Reaches 100% capacity in approximately 3 hours using a self-aligning magnetic USB charger. Data collection temporarily pauses during charging cycles for patient safety.

What are the physical dimensions, weight, and wear ergonomics of the device?

Engineered specifically for continuous 24/7 patient tolerance, the CardioWatch bracelet weighs just 18 grams with ultra-compact physical dimensions of 24.4 x 40.4 x 9.8 mm. Comfortable, biocompatible strap options in multiple materials (silicone rubber, hypo-allergenic cloth) enable long-term compliance in senior, adult, and pediatric study cohorts.

Can the device be exposed to water or worn during hygiene routines?

CardioWatch 287 is rated IP66 water-resistant, protecting the sensor casing against dust intrusion and high-pressure water sprays. Patients can wear the device safely during standard showers, but it should not be submerged in deep water or used during swimming routines.

3. Sensors, Vital Parameters & Raw Data Access

Which continuously derived vital parameters are monitored by CardioWatch?

CardioWatch 287 derives up to 19 validated physiological parameters continuously, eliminating snapshot gaps between manual nursing rounds:

Cardiovascular: Continuous Pulse Rate, Heart Rate Variability (HRV), Non-Invasive Blood Pressure (NIBP trends), Single-lead ECG strips.
Respiratory & Oxygenation: Respiration Rate, SpO2 (Blood Oxygen Saturation).
Thermal & Electrodermal: Core Body Temperature, Electrodermal Activity (GSR / EDA).
Biromechanics: 3-axis Activity, Posture, Sleep Staging, Gait, and Frailty biomarkers.

Is raw multi-sensor signal export available for pharmaceutical AI/ML model co-development?

Yes. Corsano provides unrestricted, IP-free raw data export through the Corsano Research Portal and REST APIs. Research teams can access unfiltered raw signals at selectable sampling rates (25 Hz, 32 Hz, 64 Hz, or 128 Hz) for:

3-axis Accelerometer (ACC)
Multi-Wavelength Optical Photoplethysmography (PPG Green, Red, Infrared)
Bioimpedance / Single-Lead Electrocardiogram (BIOZ / ECG)

How does the optical PPG sensor perform across different Fitzpatrick skin tones?

The multi-wavelength PPG optical architecture in CardioWatch adjusts LED intensity and wavelength dynamically. Clinical trials benchmarking Pulse Rate, SpO2, and Respiration Rate against gold-standard reference monitors demonstrated equal signal fidelity and accuracy across all Fitzpatrick skin types (I through VI).

4. System Integration & Data Security

How does Corsano integrate continuous vital signs into existing hospital EMR dashboards?

Physiological trend outputs and Early Warning Scores (EWS) sync seamlessly via documented REST APIs, mobile SDKs, and gateway applications. This architecture connects directly with electronic medical record platforms, nurse station dashboards, or custom clinical research databases without altering established nursing workflows.

What cyber-security measures and privacy frameworks safeguard patient health data?

Data security is managed through enterprise-grade cloud architecture on Amazon Web Services (AWS). End-to-end encryption protects stored and transmitted data under strict compliance with EU GDPR, US HIPAA, and ISO 27001 guidelines. Data ownership stays fully with the clinical institution or sponsor; records are archived securely and purged upon official protocol request.

5. Clinical Validation & Evidence

Which clinical research centers have benchmarked and validated Corsano's vital algorithms?

Corsano's vital sign algorithms are backed by clinical trial validations conducted across leading European medical institutions, including Radboud University Medical Center, Erasmus MC, Amsterdam UMC, Haaglanden Clinics, and Reinier de Graaf Hospital. Validated domains cover continuous SpO2 accuracy, PPG-based sleep staging, atrial fibrillation detection, core body temperature tracking, and early warning scores for cardiac deterioration.

Can auxiliary medical devices be paired into the Corsano patient ecosystem?

Yes. The Corsano hub ecosystem integrates peripheral Bluetooth medical sensors into one unified record, including Corsano Wireless Blood Pressure Cuffs, Precision Weight Scales, MIR Spirometers, and auxiliary ECG patches.

Evaluate Continuous Patient Monitoring for Your Institution

Consult with our clinical device specialists to review parameter configurations, API integration guides, bulk procurement options, or trial pilot protocols.

Feature availability, specific algorithm clearance, and product configurations may vary by country or region subject to applicable regulatory approvals, local clearances, and medical device requirements.