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OUR TECHNOLOGY
The SIVA System is a novel patient-centric and fully automated 24/7 cough detection solution, that provides longitudinal real-life cough profiles and contextual data to healthcare professionals, pharmaceutical study sponsors and researchers.​
THE DATA YOU GET
Cough Profiles
Continuous and reliable 24/7 measurement of frequency, bouts and intensity over several weeks or months
Wearing Adherence
Overview of wearing compliance and adherence monitoring
Patient-Reported Outcomes
Self-reported timing of meal intake and your choice of questionnaires for subjective outcome assesment for optimal treatment solutions
Contextual Insights
Physical activity levels, pollen load, humidity, air quality for exploratory information
SIVA WEARABLE COUGH MONITOR
The SIVA Wearable cough monitor is a small device with various sensors (sound, vibrations).
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During the day: worn around the neck on a strap at chest level
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During sleep: placed next to the bed and simultaneously charged by a charger
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The sensors record cough continuously.​​
Easy to Wear
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Inconspicious (worn under cloths, friendly appearance)
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Light-weight (30 g)
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Small (50 mm x 40 mm x 12.5 mm)
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Neck strap with magnetic closure
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Water-resistant (IP57)
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Always on (battery for up to 24h, wireless charger included)
Medical Grade
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Compliant with medical device safety standards for home use, electromagnetic compatibility, usability and biological safety: IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, IEC 60601-1-6, ISO 10993
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CE mark as medical device accessory
SIVA CORE SECURE CLOUD
​SIVA Core is the secure cloud software at the center of the SIVA Cough Monitoring System for cough data processing, data storage and visualization.
​Guaranteed Privacy
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Secure European data center infrastructure compliant with applicable data security and privacy standards (ISO 27001, ISO 27017, ISO 27018, and ISO 22301)
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Fully privacy-preserving (end-to-end data encryption from data capture to fully automated processing, no human listeners involved)
Medical Grade
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Dashboard for patient management and data monitoring, customizable visibility to respect study staff blinding requirements
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Compliant with health and medical device software standards: IEC 82304-1, IEC 62304; passed Technical Documentation assessment for cybersecurity and AI-based medical devices by European Notified Body
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Available as medical device version (CE mark, class IIa medical device) and research tool version​
SIVA SMARTPHONE APPLICATION
The SIVA Smartphone Application collects information from patients via a Daily Diary (e.g., mealtimes, patient-reported outcomes) and manages the SIVA Wearable.
​​Medical Grade
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Easy-to-use (Validated usability according to EN 62366-1)
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Compliant with health and medical device software standards: IEC 82304-1, IEC 62304
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Available as a medical-grade (CE mark, class IIa medical device accessory) and research tool version
Fully automated continuous long-term cough monitoring, designed for clinical use from the start: the SIVA System combines rigorous medical device quality, user-centric development, and innovative technology.
Optimal Placement
A cough monitor placed on the chest ensures highly specific measurement and excellent data quality.
Medical Grade
First fully automated cough monitoring system approved as a medical device (CE mark, class IIa).
Easy to Wear
Convenient neck straps allow putting on the light-weight device in seconds, and users do not notice wearing it after a few minutes.
Clinically Validated
Excellent cough detection performance and usability proven in clinical validation studies.
Guaranteed Privacy
End-to-end data encryption between sensor and automated processing unit, no human listeners involved.
VOICE AND SOUND BIOMARKERS
Our system is easily adaptable for collecting other voice and sound biomarkers. Reach out to us to discuss technology solutions!
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